Trial Outcomes & Findings for Etanercept Withdrawal And Retreament Study In Subjects With Nr-ax SpA (NCT NCT02509026)
NCT ID: NCT02509026
Last Updated: 2020-06-16
Results Overview
Participants who experienced ASDAS-Erythrocyte Sedimentation Rate (ESR) level of \>=2.1 were defined as being flared. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0 = no disease activity and 10= high disease activity. CRP measured in milligram per liter (mg/L) and ESR measured in millimeter per hour (mm/hr). Percentage of participants who flared within 40 weeks after the withdrawal of Etanercept treatment of 24 weeks in Induction period are reported in this outcome measure.
COMPLETED
PHASE4
210 participants
Within 40 weeks after Etanercept withdrawal (from Week 24 to Week 64)
2020-06-16
Participant Flow
The first visit of the Period 3 (re-treatment period) might occur at the same time as a regularly scheduled visit during Period 2 (withdrawal period) or as an unscheduled visit for a participant who experienced flare during Period 2.
Participant milestones
| Measure |
Etanercept
All enrolled participants with non-radiographic axial spondyloarthritis (nr-ax SpA) were treated for 24 weeks with 50-milligram (mg) weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ankylosing spondylitis disease activity scale (ASDAS) C-reactive protein (CRP) level less than (\<) 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS erythrocyte sedimentation rate (ESR) level greater than or equal to (\>=) 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
|---|---|
|
Induction Period (24 Weeks)
STARTED
|
210
|
|
Induction Period (24 Weeks)
Treated
|
209
|
|
Induction Period (24 Weeks)
COMPLETED
|
188
|
|
Induction Period (24 Weeks)
NOT COMPLETED
|
22
|
|
Withdrawal Period (40 Weeks)
STARTED
|
119
|
|
Withdrawal Period (40 Weeks)
COMPLETED
|
112
|
|
Withdrawal Period (40 Weeks)
NOT COMPLETED
|
7
|
|
Retreatment Period (12 Weeks)
STARTED
|
88
|
|
Retreatment Period (12 Weeks)
Treated
|
87
|
|
Retreatment Period (12 Weeks)
COMPLETED
|
84
|
|
Retreatment Period (12 Weeks)
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Etanercept
All enrolled participants with non-radiographic axial spondyloarthritis (nr-ax SpA) were treated for 24 weeks with 50-milligram (mg) weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ankylosing spondylitis disease activity scale (ASDAS) C-reactive protein (CRP) level less than (\<) 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS erythrocyte sedimentation rate (ESR) level greater than or equal to (\>=) 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
|---|---|
|
Induction Period (24 Weeks)
Adverse Event
|
5
|
|
Induction Period (24 Weeks)
Eligibility Criteria
|
5
|
|
Induction Period (24 Weeks)
Lack of Efficacy
|
6
|
|
Induction Period (24 Weeks)
Lost to Follow-up
|
1
|
|
Induction Period (24 Weeks)
Other
|
2
|
|
Induction Period (24 Weeks)
Protocol Violation
|
1
|
|
Induction Period (24 Weeks)
Withdrawal by Subject
|
1
|
|
Induction Period (24 Weeks)
Enrolled but not treated
|
1
|
|
Withdrawal Period (40 Weeks)
Protocol Violation
|
2
|
|
Withdrawal Period (40 Weeks)
Withdrawal by Subject
|
5
|
|
Retreatment Period (12 Weeks)
Lost to Follow-up
|
1
|
|
Retreatment Period (12 Weeks)
Withdrawal by Subject
|
2
|
|
Retreatment Period (12 Weeks)
Enrolled but not treated
|
1
|
Baseline Characteristics
Etanercept Withdrawal And Retreament Study In Subjects With Nr-ax SpA
Baseline characteristics by cohort
| Measure |
Etanercept
n=209 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
|---|---|
|
Age, Continuous
|
33.1 Years
STANDARD_DEVIATION 8.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
186 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 40 weeks after Etanercept withdrawal (from Week 24 to Week 64)Population: Full analysis set for period 2 included all participants who had at least one evaluation during period 2. Missing data was imputed using mixed last observation carried forward (LOCF).
Participants who experienced ASDAS-Erythrocyte Sedimentation Rate (ESR) level of \>=2.1 were defined as being flared. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0 = no disease activity and 10= high disease activity. CRP measured in milligram per liter (mg/L) and ESR measured in millimeter per hour (mm/hr). Percentage of participants who flared within 40 weeks after the withdrawal of Etanercept treatment of 24 weeks in Induction period are reported in this outcome measure.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Experienced Flare Within 40 Weeks Following Withdrawal of 24 Weeks of Etanercept Treatment
|
74.8 percentage of participants
Interval 66.3 to 82.04
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 40 weeks after Etanercept withdrawal (from Week 24 to Week 64)Population: Full analysis set for period 2 included all participants who had at least one evaluation during period 2.
Participants who experienced ASDAS-ESR level of \>=2.1 were defined as being flared. Time to experience flare in participants was defined as time to achieve ASDAS-ESR level of \>=2.1 after the withdrawal of Etanercept treatment of 24 weeks in induction period. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0 = no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Time to Flare Following Withdrawal of Etanercept Treatment
|
16.1 weeks
Interval 12.57 to 24.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0 \<= ASDAS-CRP \<1.3; moderate disease activity: 1.3 \<= ASDAS-CRP \<2.1; high disease activity: 2.1 \<= ASDAS-CRP \<=3.5; very high disease activity: 3.5 \< ASDAS-CRP.
Outcome measures
| Measure |
Etanercept
n=208 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 1
Baseline
|
0.5 percentage of participants
Interval 0.05 to 2.25
|
—
|
—
|
|
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 1
Week 4
|
14.4 percentage of participants
Interval 10.15 to 19.68
|
—
|
—
|
|
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 1
Week 8
|
27.4 percentage of participants
Interval 21.55 to 33.82
|
—
|
—
|
|
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 1
Week 12
|
38.1 percentage of participants
Interval 31.5 to 44.99
|
—
|
—
|
|
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 1
Week 16
|
41.9 percentage of participants
Interval 35.05 to 48.96
|
—
|
—
|
|
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 1
Week 24
|
62.6 percentage of participants
Interval 55.6 to 69.28
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 28, 32, 40, 48, 56, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Here, "number analyzed" signifies participants evaluable at specific time points.
ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0 \<= ASDAS-CRP \<1.3; moderate disease activity: 1.3 \<= ASDAS-CRP \<2.1; high disease activity: 2.1 \<= ASDAS-CRP \<=3.5; very high disease activity: 3.5 \< ASDAS-CRP.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 2
Week 28
|
52.7 percentage of participants
Interval 43.43 to 61.89
|
—
|
—
|
|
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 2
Week 32
|
45.2 percentage of participants
Interval 35.32 to 55.29
|
—
|
—
|
|
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 2
Week 40
|
48.5 percentage of participants
Interval 36.71 to 60.39
|
—
|
—
|
|
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 2
Week 48
|
42.0 percentage of participants
Interval 29.09 to 55.81
|
—
|
—
|
|
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 2
Week 56
|
56.1 percentage of participants
Interval 40.93 to 70.44
|
—
|
—
|
|
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 2
Week 64
|
55.9 percentage of participants
Interval 39.28 to 71.53
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 68, 72, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Here, "number analyzed" signifies participants evaluable at specific time points.
ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0 \<= ASDAS-CRP \<1.3; moderate disease activity: 1.3 \<= ASDAS-CRP \<2.1; high disease activity: 2.1 \<= ASDAS-CRP \<=3.5; very high disease activity: 3.5 \< ASDAS-CRP.
Outcome measures
| Measure |
Etanercept
n=87 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 3
Week 68
|
53.6 percentage of participants
Interval 42.94 to 63.96
|
—
|
—
|
|
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 3
Week 72
|
61.6 percentage of participants
Interval 51.1 to 71.38
|
—
|
—
|
|
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 3
Week 76
|
62.4 percentage of participants
Interval 51.78 to 72.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Missing data was imputed using mixed LOCF. Overall Number of Participants Analyzed" = participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0 \<= ASDAS-CRP \<1.3; moderate disease activity: 1.3 \<= ASDAS-CRP \<2.1; high disease activity: 2.1 \<= ASDAS-CRP \<=3.5; very high disease activity: 3.5 \< ASDAS-CRP.
Outcome measures
| Measure |
Etanercept
n=208 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<) 1.3: Last Observation Carried Forward (LOCF): Period 1
Baseline
|
0.5 percentage of participants
Interval 0.05 to 2.25
|
—
|
—
|
|
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<) 1.3: Last Observation Carried Forward (LOCF): Period 1
Week 4
|
14.4 percentage of participants
Interval 10.15 to 19.68
|
—
|
—
|
|
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<) 1.3: Last Observation Carried Forward (LOCF): Period 1
Week 8
|
27.4 percentage of participants
Interval 21.68 to 33.75
|
—
|
—
|
|
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<) 1.3: Last Observation Carried Forward (LOCF): Period 1
Week 12
|
36.5 percentage of participants
Interval 30.22 to 43.23
|
—
|
—
|
|
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<) 1.3: Last Observation Carried Forward (LOCF): Period 1
Week 16
|
40.4 percentage of participants
Interval 33.89 to 47.15
|
—
|
—
|
|
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<) 1.3: Last Observation Carried Forward (LOCF): Period 1
Week 24
|
58.7 percentage of participants
Interval 51.88 to 65.19
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 28, 32, 40, 48, 56, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0 \<= ASDAS-CRP \<1.3; moderate disease activity: 1.3 \<= ASDAS-CRP \<2.1; high disease activity: 2.1 \<= ASDAS-CRP \<=3.5; very high disease activity: 3.5 \< ASDAS-CRP.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<) 1.3: Last Observation Carried Forward (LOCF): Period 2
Week 28
|
52.7 percentage of participants
Interval 43.43 to 61.89
|
—
|
—
|
|
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<) 1.3: Last Observation Carried Forward (LOCF): Period 2
Week 32
|
39.8 percentage of participants
Interval 31.15 to 49.01
|
—
|
—
|
|
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<) 1.3: Last Observation Carried Forward (LOCF): Period 2
Week 40
|
34.5 percentage of participants
Interval 26.23 to 43.58
|
—
|
—
|
|
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<) 1.3: Last Observation Carried Forward (LOCF): Period 2
Week 48
|
26.5 percentage of participants
Interval 19.07 to 35.21
|
—
|
—
|
|
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<) 1.3: Last Observation Carried Forward (LOCF): Period 2
Week 56
|
29.2 percentage of participants
Interval 21.42 to 38.03
|
—
|
—
|
|
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<) 1.3: Last Observation Carried Forward (LOCF): Period 2
Week 64
|
24.8 percentage of participants
Interval 17.52 to 33.31
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 68, 72, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0 \<= ASDAS-CRP \<1.3; moderate disease activity: 1.3 \<= ASDAS-CRP \<2.1; high disease activity: 2.1 \<= ASDAS-CRP \<=3.5; very high disease activity: 3.5 \< ASDAS-CRP.
Outcome measures
| Measure |
Etanercept
n=87 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<) 1.3: Last Observation Carried Forward (LOCF): Period 3
Week 68
|
52.9 percentage of participants
Interval 42.38 to 63.31
|
—
|
—
|
|
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<) 1.3: Last Observation Carried Forward (LOCF): Period 3
Week 72
|
60.9 percentage of participants
Interval 50.45 to 70.68
|
—
|
—
|
|
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<) 1.3: Last Observation Carried Forward (LOCF): Period 3
Week 76
|
62.1 percentage of participants
Interval 51.61 to 71.74
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4, 8, 12, 16, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Here, "Overall Number of Participants Analyzed" signifies participants evaluable at this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from \[Bath Ankylosing Spondylitis Functional Index\] BASFI) and inflammation (from \[Bath Ankylosing Spondylitis Disease Activity Index\] BASDAI). ASAS 20 responders were defined as participants with at least 20% improvement from baseline in disease activity and an absolute change of at least 1 unit on a 0 to 10 cm scale (0=no disease activity; 10=high disease activity, where higher scores indicated higher disease activity) in 3 or more domains, and no worsening of \>=20% and absolute change 1 unit in the remaining domain. All 4 domains were measured on a 0-100 millimeter (mm) scale (0= no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 20.
Outcome measures
| Measure |
Etanercept
n=208 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Observed Cases (OC): Period 1
Week 4
|
58.7 percentage of participants
Interval 51.88 to 65.19
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Observed Cases (OC): Period 1
Week 8
|
68.7 percentage of participants
Interval 62.01 to 74.77
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Observed Cases (OC): Period 1
Week 12
|
71.7 percentage of participants
Interval 65.16 to 77.64
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Observed Cases (OC): Period 1
Week 16
|
78.1 percentage of participants
Interval 71.88 to 83.52
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Observed Cases (OC): Period 1
Week 24
|
85.8 percentage of participants
Interval 80.3 to 90.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 28, 32, 40, 48, 56, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Here, "number analyzed" signifies participants evaluable at specific time points.
ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 20 responders were defined as participants with at least 20% improvement from baseline in disease activity and an absolute change of at least 1 unit on a 0 to 10 cm scale (0=no disease activity; 10=high disease activity, where higher scores indicated higher disease activity) in 3 or more domains, and no worsening of \>=20% and absolute change 1 unit in the remaining domain. All 4 domains were measured on a 0-100 millimeter (mm) scale (0= no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 20.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Observed Cases (OC): Period 2
Week 28
|
86.0 percentage of participants
Interval 78.21 to 91.74
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Observed Cases (OC): Period 2
Week 32
|
88.9 percentage of participants
Interval 80.71 to 94.36
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Observed Cases (OC): Period 2
Week 40
|
83.1 percentage of participants
Interval 72.02 to 90.94
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Observed Cases (OC): Period 2
Week 48
|
91.5 percentage of participants
Interval 81.02 to 97.06
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Observed Cases (OC): Period 2
Week 56
|
91.4 percentage of participants
Interval 78.86 to 97.53
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Observed Cases (OC): Period 2
Week 64
|
92.6 percentage of participants
Interval 78.3 to 98.43
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 64, 68, 72, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Here, "number analyzed" signifies participants evaluable at specific time points.
ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 20 responders: participants with at least 20% improvement from baseline in disease activity and an absolute change of at least 1 unit on 0 to 10 cm scale(0=no disease activity; 10=high disease activity, where higher scores indicated higher disease activity)in 3 or more domains, and no worsening of \>=20% and absolute change 1 unit in the remaining domain. All 4 domains measured on 0-100 millimeter (mm) scale (0= no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 20.
Outcome measures
| Measure |
Etanercept
n=87 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Observed Cases (OC): Period 3
Week 64
|
33.3 percentage of participants
Interval 14.03 to 58.42
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Observed Cases (OC): Period 3
Week 68
|
80.0 percentage of participants
Interval 70.58 to 87.42
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Observed Cases (OC): Period 3
Week 72
|
81.6 percentage of participants
Interval 72.51 to 88.65
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Observed Cases (OC): Period 3
Week 76
|
87.1 percentage of participants
Interval 78.72 to 92.93
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4, 8, 12, 16, 24Population: FAS for Period 1 included all participants who took study medication and had one evaluation after baseline. Missing data was imputed using mixed LOCF. "Overall Number of Participants Analyzed" included participants who were evaluable for this outcome measure.
ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 20 responders were defined as participants with at least 20% improvement from baseline in disease activity and an absolute change of at least 1 unit on a 0 to 10 cm scale (0=no disease activity; 10=high disease activity, where higher scores indicated higher disease activity) in 3 or more domains, and no worsening of \>=20% and absolute change 1 unit in the remaining domain. All 4 domains were measured on a 0-100 millimeter (mm) scale (0= no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 20.
Outcome measures
| Measure |
Etanercept
n=208 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Last Observation Carried Forward (LOCF): Period 1
Week 4
|
58.7 percentage of participants
Interval 51.88 to 65.19
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Last Observation Carried Forward (LOCF): Period 1
Week 8
|
68.8 percentage of participants
Interval 62.23 to 74.76
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Last Observation Carried Forward (LOCF): Period 1
Week 12
|
71.2 percentage of participants
Interval 64.74 to 76.99
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Last Observation Carried Forward (LOCF): Period 1
Week 16
|
76.4 percentage of participants
Interval 70.34 to 81.82
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Last Observation Carried Forward (LOCF): Period 1
Week 24
|
83.2 percentage of participants
Interval 77.65 to 87.78
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 28, 32, 40, 48, 56, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 20 responders were defined as participants with at least 20% improvement from baseline in disease activity and an absolute change of at least 1 unit on a 0 to 10 cm scale (0=no disease activity; 10=high disease activity, where higher scores indicated higher disease activity) in 3 or more domains, and no worsening of \>=20% and absolute change 1 unit in the remaining domain. All 4 domains were measured on a 0-100 millimeter (mm) scale (0= no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 20.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Last Observation Carried Forward (LOCF): Period 2
Week 28
|
86.0 percentage of participants
Interval 78.21 to 91.74
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Last Observation Carried Forward (LOCF): Period 2
Week 32
|
84.3 percentage of participants
Interval 76.34 to 90.37
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Last Observation Carried Forward (LOCF): Period 2
Week 40
|
79.4 percentage of participants
Interval 70.81 to 86.37
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Last Observation Carried Forward (LOCF): Period 2
Week 48
|
79.4 percentage of participants
Interval 70.81 to 86.37
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Last Observation Carried Forward (LOCF): Period 2
Week 56
|
78.4 percentage of participants
Interval 69.73 to 85.55
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Last Observation Carried Forward (LOCF): Period 2
Week 64
|
77.5 percentage of participants
Interval 68.65 to 84.72
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 64, 68, 72, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 20 responders: participants with at least 20% improvement from baseline in disease activity and an absolute change of at least 1 unit on 0 to 10 cm scale(0=no disease activity; 10=high disease activity, where higher scores indicated higher disease activity)in 3 or more domains, and no worsening of \>=20% and absolute change 1 unit in the remaining domain. All 4 domains measured on 0-100 millimeter (mm) scale (0= no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 20.
Outcome measures
| Measure |
Etanercept
n=87 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Last Observation Carried Forward (LOCF): Period 3
Week 68
|
79.1 percentage of participants
Interval 69.6 to 86.62
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Last Observation Carried Forward (LOCF): Period 3
Week 64
|
33.3 percentage of participants
Interval 14.03 to 58.42
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Last Observation Carried Forward (LOCF): Period 3
Week 72
|
81.6 percentage of participants
Interval 72.51 to 88.65
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Last Observation Carried Forward (LOCF): Period 3
Week 76
|
86.2 percentage of participants
Interval 77.82 to 92.23
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4, 8, 12, 16, 24Population: FAS for Period 1 included all participants who took study medication and had one evaluation after baseline. Missing data was imputed using mixed LOCF. "Overall Number of Participants Analyzed" included participants who were evaluable for this outcome measure.
ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 40 responders were defined as participants with at least 40% and absolute improvement of at least 2 units on a 0 to 10 cm scale (converted from 0 to 100 mm) or an improvement of 100% for those domains that have a baseline score \<2 in at least 3 of the 4 domains: participant assessment of disease activity, mean of participants assessment of total back pain, function represented by the BASFI score, inflammation represented by the mean of the two morning stiffness-related BASDAI scores. No worsening at all in any of the domains. Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 40.
Outcome measures
| Measure |
Etanercept
n=208 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Last Observation Carried Forward (LOCF): Period 1
Week 4
|
34.6 percentage of participants
Interval 28.4 to 41.26
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Last Observation Carried Forward (LOCF): Period 1
Week 8
|
49.0 percentage of participants
Interval 42.3 to 55.81
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Last Observation Carried Forward (LOCF): Period 1
Week 12
|
51.0 percentage of participants
Interval 44.19 to 57.7
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Last Observation Carried Forward (LOCF): Period 1
Week 16
|
61.1 percentage of participants
Interval 54.32 to 67.49
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Last Observation Carried Forward (LOCF): Period 1
Week 24
|
71.6 percentage of participants
Interval 65.24 to 77.43
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 28, 32, 40, 48, 56, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 40 responders were defined as participants with at least 40% and absolute improvement of at least 2 units on a 0 to 10 cm scale (converted from 0 to 100 mm) or an improvement of 100% for those domains that have a baseline score \<2 in at least 3 of the 4 domains: participant assessment of disease activity, mean of participants assessment of total back pain, function represented by the BASFI score, inflammation represented by the mean of the two morning stiffness-related BASDAI scores. No worsening at all in any of the domains. Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 40.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Last Observation Carried Forward (LOCF): Period 2
Week 28
|
77.0 percentage of participants
Interval 68.06 to 84.4
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Last Observation Carried Forward (LOCF): Period 2
Week 32
|
72.5 percentage of participants
Interval 63.35 to 80.49
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Last Observation Carried Forward (LOCF): Period 2
Week 40
|
69.6 percentage of participants
Interval 60.23 to 77.89
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Last Observation Carried Forward (LOCF): Period 2
Week 48
|
64.7 percentage of participants
Interval 55.12 to 73.47
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Last Observation Carried Forward (LOCF): Period 2
Week 56
|
66.7 percentage of participants
Interval 57.15 to 75.25
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Last Observation Carried Forward (LOCF): Period 2
Week 64
|
62.7 percentage of participants
Interval 53.11 to 71.67
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 64, 68, 72, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 40 responders were defined as participants with at least 40% and absolute improvement of at least 2 units on a 0 to 10 cm scale (converted from 0 to 100 mm) or an improvement of 100% for those domains that have a baseline score \<2 in at least 3 of the 4 domains: participant assessment of disease activity, mean of participants assessment of total back pain, function represented by the BASFI score, inflammation represented by the mean of the two morning stiffness-related BASDAI scores. No worsening at all in any of the domains. Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 40.
Outcome measures
| Measure |
Etanercept
n=87 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Last Observation Carried Forward (LOCF): Period 3
Week 64
|
20.0 percentage of participants
Interval 5.98 to 44.36
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Last Observation Carried Forward (LOCF): Period 3
Week 68
|
67.4 percentage of participants
Interval 57.09 to 76.64
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Last Observation Carried Forward (LOCF): Period 3
Week 72
|
74.7 percentage of participants
Interval 64.88 to 82.94
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Last Observation Carried Forward (LOCF): Period 3
Week 76
|
77.0 percentage of participants
Interval 67.38 to 84.88
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4, 8, 12, 16, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Here, "Overall Number of Participants Analyzed" signifies participants evaluable at this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 40 responders were defined as participants with at least 40% and absolute improvement of at least 2 units on a 0 to 10 cm scale (converted from 0 to 100 mm) or an improvement of 100% for those domains that have a baseline score \<2 in at least 3 of the 4 domains: participant assessment of disease activity, mean of participants assessment of total back pain, function represented by the BASFI score, inflammation represented by the mean of the two morning stiffness-related BASDAI scores. No worsening at all in any of the domains. Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 40.
Outcome measures
| Measure |
Etanercept
n=208 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Observed Cases (OC): Period 1
Week 4
|
34.6 percentage of participants
Interval 28.4 to 41.26
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Observed Cases (OC): Period 1
Week 8
|
49.3 percentage of participants
Interval 42.39 to 56.13
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Observed Cases (OC): Period 1
Week 12
|
52.5 percentage of participants
Interval 45.58 to 59.4
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Observed Cases (OC): Period 1
Week 16
|
64.1 percentage of participants
Interval 57.11 to 70.6
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Observed Cases (OC): Period 1
Week 24
|
75.8 percentage of participants
Interval 69.34 to 81.46
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 28, 32, 40, 48, 56, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Here, "number analyzed" signifies participants evaluable at specific time points.
ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 40 responders were defined as participants with at least 40% and absolute improvement of at least 2 units on a 0 to 10 cm scale (converted from 0 to 100 mm) or an improvement of 100% for those domains that have a baseline score \<2 in at least 3 of the 4 domains: participant assessment of disease activity, mean of participants assessment of total back pain, function represented by the BASFI score, inflammation represented by the mean of the two morning stiffness-related BASDAI scores. No worsening at all in any of the domains. Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 40.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Observed Cases (OC): Period 2
Week 28
|
77.0 percentage of participants
Interval 68.06 to 84.4
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Observed Cases (OC): Period 2
Week 32
|
77.8 percentage of participants
Interval 67.85 to 85.76
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Observed Cases (OC): Period 2
Week 40
|
74.6 percentage of participants
Interval 62.48 to 84.33
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Observed Cases (OC): Period 2
Week 48
|
74.5 percentage of participants
Interval 60.81 to 85.22
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Observed Cases (OC): Period 2
Week 56
|
82.9 percentage of participants
Interval 68.03 to 92.51
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Observed Cases (OC): Period 2
Week 64
|
74.1 percentage of participants
Interval 55.71 to 87.58
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 64, 68, 72, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Here, "number analyzed" signifies participants evaluable at specific time points.
ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 40 responders were defined as participants with at least 40% and absolute improvement of at least 2 units on a 0 to 10 cm scale (converted from 0 to 100 mm) or an improvement of 100% for those domains that have a baseline score \<2 in at least 3 of the 4 domains: participant assessment of disease activity, mean of participants assessment of total back pain, function represented by the BASFI score, inflammation represented by the mean of the two morning stiffness-related BASDAI scores. No worsening at all in any of the domains. Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 40.
Outcome measures
| Measure |
Etanercept
n=87 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Observed Cases (OC): Period 3
Week 64
|
20.0 percentage of participants
Interval 5.98 to 44.36
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Observed Cases (OC): Period 3
Week 68
|
68.2 percentage of participants
Interval 57.86 to 77.4
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Observed Cases (OC): Period 3
Week 72
|
74.7 percentage of participants
Interval 64.88 to 82.94
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Observed Cases (OC): Period 3
Week 76
|
78.8 percentage of participants
Interval 69.27 to 86.46
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4, 8, 12, 16, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Missing data was imputed using mixed LOCF. Here, "Overall Number of Participants Analyzed" included participants who were evaluable for this outcome measure.
ASAS partial remission was defined as a score of 2 units or less (on a scale of 0-10 cm, where 0 = no disease activity and 10 = high disease activity) in each of the 4 domains of ASAS: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). Reported values were then converted into cm for analysis.
Outcome measures
| Measure |
Etanercept
n=208 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Last Observation Carried Forward (LOCF): Period 1
Week 4
|
19.2 percentage of participants
Interval 14.32 to 24.99
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Last Observation Carried Forward (LOCF): Period 1
Week 8
|
29.8 percentage of participants
Interval 23.9 to 36.27
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Last Observation Carried Forward (LOCF): Period 1
Week 12
|
37.0 percentage of participants
Interval 30.67 to 43.72
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Last Observation Carried Forward (LOCF): Period 1
Week 16
|
40.9 percentage of participants
Interval 34.35 to 47.63
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Last Observation Carried Forward (LOCF): Period 1
Week 24
|
58.2 percentage of participants
Interval 51.39 to 64.73
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 28, 32, 40, 48, 56, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
ASAS partial remission was defined as a score of 2 units or less (on a scale of 0-10 cm, where 0 = no disease activity and 10 = high disease activity) in each of the 4 domains of ASAS: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). Reported values were then converted into cm for analysis.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Last Observation Carried Forward (LOCF): Period 2
Week 28
|
63.0 percentage of participants
Interval 53.28 to 71.98
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Last Observation Carried Forward (LOCF): Period 2
Week 32
|
53.9 percentage of participants
Interval 44.25 to 63.37
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Last Observation Carried Forward (LOCF): Period 2
Week 40
|
48.0 percentage of participants
Interval 38.51 to 57.68
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Last Observation Carried Forward (LOCF): Period 2
Week 48
|
41.2 percentage of participants
Interval 31.98 to 50.86
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Last Observation Carried Forward (LOCF): Period 2
Week 56
|
44.1 percentage of participants
Interval 34.76 to 53.81
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Last Observation Carried Forward (LOCF): Period 2
Week 64
|
41.2 percentage of participants
Interval 31.98 to 50.86
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 64, 68, 72, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
ASAS partial remission was defined as a score of 2 units or less (on a scale of 0-10 cm, where 0 = no disease activity and 10 = high disease activity) in each of the 4 domains of ASAS: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). Reported values were then converted into cm for analysis.
Outcome measures
| Measure |
Etanercept
n=87 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Last Observation Carried Forward (LOCF): Period 3
Week 64
|
0.0 percentage of participants
Interval 0.0 to 15.18
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Last Observation Carried Forward (LOCF): Period 3
Week 68
|
45.3 percentage of participants
Interval 35.13 to 55.88
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Last Observation Carried Forward (LOCF): Period 3
Week 72
|
55.2 percentage of participants
Interval 44.7 to 65.31
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Last Observation Carried Forward (LOCF): Period 3
Week 76
|
52.9 percentage of participants
Interval 42.43 to 63.13
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4, 8, 12, 16, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Here, "Overall Number of Participants Analyzed" signifies participants evaluable at this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
ASAS partial remission was defined as a score of 2 units or less (on a scale of 0-10 cm, where 0 = no disease activity and 10 = high disease activity) in each of the 4 domains of ASAS: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). Reported values were then converted into cm for analysis.
Outcome measures
| Measure |
Etanercept
n=208 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Observed Cases (OC): Period 1
Week 4
|
19.2 percentage of participants
Interval 14.32 to 24.99
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Observed Cases (OC): Period 1
Week 8
|
30.3 percentage of participants
Interval 24.31 to 36.95
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Observed Cases (OC): Period 1
Week 12
|
38.9 percentage of participants
Interval 32.3 to 45.8
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Observed Cases (OC): Period 1
Week 16
|
42.7 percentage of participants
Interval 35.86 to 49.77
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Observed Cases (OC): Period 1
Week 24
|
62.1 percentage of participants
Interval 55.07 to 68.78
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 28, 32, 40, 48, 56, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Here, "number analyzed" signifies participants evaluable at specific time points.
ASAS partial remission was defined as a score of 2 units or less (on a scale of 0-10 cm, where 0 = no disease activity and 10 = high disease activity) in each of the 4 domains of ASAS: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). Reported values were then converted into cm for analysis.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Observed Cases (OC): Period 2
Week 64
|
70.4 percentage of participants
Interval 51.75 to 84.88
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Observed Cases (OC): Period 2
Week 28
|
63.0 percentage of participants
Interval 53.28 to 71.98
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Observed Cases (OC): Period 2
Week 32
|
58.0 percentage of participants
Interval 47.15 to 68.34
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Observed Cases (OC): Period 2
Week 40
|
59.3 percentage of participants
Interval 46.59 to 71.16
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Observed Cases (OC): Period 2
Week 48
|
51.1 percentage of participants
Interval 37.07 to 64.93
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Observed Cases (OC): Period 2
Week 56
|
68.6 percentage of participants
Interval 52.2 to 82.02
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 64, 68, 72, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Here, "number analyzed" signifies participants evaluable at specific time points.
ASAS partial remission was defined as a score of 2 units or less (on a scale of 0-10 cm, where 0 = no disease activity and 10 = high disease activity) in each of the 4 domains of ASAS: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). Reported values were then converted into cm for analysis.
Outcome measures
| Measure |
Etanercept
n=87 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Observed Cases (OC): Period 3
Week 64
|
0.0 percentage of participants
Interval 0.0 to 15.18
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Observed Cases (OC): Period 3
Week 68
|
45.9 percentage of participants
Interval 35.57 to 56.47
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Observed Cases (OC): Period 3
Week 72
|
55.2 percentage of participants
Interval 44.7 to 65.31
|
—
|
—
|
|
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Observed Cases (OC): Period 3
Week 76
|
52.9 percentage of participants
Interval 42.38 to 63.31
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
ASDAS: score combining assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on VAS ranging 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0\<= ASDAS-CRP \<1.3; moderate disease activity: 1.3\<= ASDAS-CRP \<2.1; high disease activity: 2.1\<= ASDAS-CRP \<=3.5; very high disease activity: 3.5\< ASDAS-CRP. The ASDAS-CRP is calculated with the following equation: 0.121\*total back pain+0.110\*participant global+0.073\*peripheral pain/swelling+0.058\*duration of morning stiffness+0.579\*Ln(CRP+1), Ln represents the natural logarithm.
Outcome measures
| Measure |
Etanercept
n=209 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 1
Baseline
|
3.54 units on a scale
Standard Deviation 0.87
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 1
Change at week 4
|
-1.27 units on a scale
Standard Deviation 1.02
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 1
Change at week 8
|
-1.53 units on a scale
Standard Deviation 1.09
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 1
Change at week 12
|
-1.62 units on a scale
Standard Deviation 1.15
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 1
Change at week 16
|
-1.77 units on a scale
Standard Deviation 1.13
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 1
Change at week 24
|
-2.02 units on a scale
Standard Deviation 1.15
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
ASDAS: score combining assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on VAS ranging 0-10 cm,where 0= no disease activity and 10= high disease activity.CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0\<= ASDAS-CRP \<1.3; moderate disease activity: 1.3\<= ASDAS-CRP \<2.1; high disease activity: 2.1\<= ASDAS-CRP \<=3.5; very high disease activity: 3.5\< ASDAS-CRP. The ASDAS-CRP is calculated with the following equation: 0.121\*total back pain+0.110\*participant global+0.073\*peripheral pain/swelling+0.058\*duration of morning stiffness+0.579\*Ln(CRP+1), Ln represents the natural logarithm.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 2
Period 2 Baseline
|
0.90 units on a scale
Standard Deviation 0.20
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 2
Change at Week 28 from Period 1 Baseline
|
-1.83 units on a scale
Standard Deviation 1.14
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 2
Change at Week 28 from Period 2 Baseline
|
0.66 units on a scale
Standard Deviation 0.89
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 2
Change at Week 32 from Period 1 Baseline
|
-1.54 units on a scale
Standard Deviation 1.17
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 2
Change at Week 32 from Period 2 Baseline
|
0.96 units on a scale
Standard Deviation 1.03
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 2
Change at Week 40 from Period 1 Baseline
|
-1.36 units on a scale
Standard Deviation 1.18
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 2
Change at Week 40 from Period 2 Baseline
|
1.14 units on a scale
Standard Deviation 1.07
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 1 Baseline
|
-1.22 units on a scale
Standard Deviation 1.18
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 2 Baseline
|
1.29 units on a scale
Standard Deviation 1.06
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 2
Change at Week 56 from Period 1 Baseline
|
-1.17 units on a scale
Standard Deviation 1.18
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 2
Change at Week 56 from Period 2 Baseline
|
1.34 units on a scale
Standard Deviation 1.07
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 1 Baseline
|
-1.05 units on a scale
Standard Deviation 1.16
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 2 Baseline
|
1.46 units on a scale
Standard Deviation 1.07
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3: Baseline (last visit before retreatment), Week 64, 68, 72, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
ASDAS: score combining assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on VAS ranging 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0\<= ASDAS-CRP \<1.3; moderate disease activity: 1.3\<= ASDAS-CRP \<2.1; high disease activity: 2.1\<= ASDAS-CRP \<=3.5; very high disease activity: 3.5\< ASDAS-CRP. The ASDAS-CRP is calculated with the following equation: 0.121\*total back pain+0.110\*participant global+0.073\*peripheral pain/swelling+0.058\*duration of morning stiffness+0.579\*Ln(CRP+1), Ln represents the natural logarithm.
Outcome measures
| Measure |
Etanercept
n=87 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 3
Period 3 Baseline
|
2.97 units on a scale
Standard Deviation 0.91
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 1 baseline
|
-0.44 units on a scale
Standard Deviation 1.45
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 2 baseline
|
2.08 units on a scale
Standard Deviation 0.80
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 3 baseline
|
0.23 units on a scale
Standard Deviation 0.68
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 3
Change at Week 68 from Period 1 baseline
|
-1.92 units on a scale
Standard Deviation 1.06
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 3
Change at Week 68 from Period 2 baseline
|
0.67 units on a scale
Standard Deviation 0.72
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 3
Change at Week 68 from Period 3 baseline
|
-1.41 units on a scale
Standard Deviation 0.98
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 3
Change at Week 72 from Period 1 baseline
|
-2.09 units on a scale
Standard Deviation 1.02
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 3
Change at Week 72 from Period 2 baseline
|
0.50 units on a scale
Standard Deviation 0.69
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 3
Change at Week 72 from Period 3 baseline
|
-1.58 units on a scale
Standard Deviation 0.99
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 1 baseline
|
-2.12 units on a scale
Standard Deviation 1.06
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 2 baseline
|
0.47 units on a scale
Standard Deviation 0.68
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 3 baseline
|
-1.61 units on a scale
Standard Deviation 1.04
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Here, "number analyzed" signifies participants evaluable at specific time points.
ASDAS: score combining assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on VAS ranging 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0\<= ASDAS-CRP \<1.3; moderate disease activity: 1.3\<= ASDAS-CRP \<2.1; high disease activity: 2.1\<= ASDAS-CRP \<=3.5; very high disease activity: 3.5\< ASDAS-CRP. The ASDAS-CRP is calculated with the following equation: 0.121\*total back pain+0.110\*participant global+0.073\*peripheral pain/swelling+0.058\*duration of morning stiffness+0.579\*Ln(CRP+1), Ln represents the natural logarithm.
Outcome measures
| Measure |
Etanercept
n=209 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 1
Baseline
|
3.54 units on a scale
Standard Deviation 0.87
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 1
Change at week 4
|
-1.27 units on a scale
Standard Deviation 1.02
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 1
Change at week 8
|
-1.54 units on a scale
Standard Deviation 1.10
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 1
Change at week 12
|
-1.66 units on a scale
Standard Deviation 1.15
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 1
Change at week 16
|
-1.85 units on a scale
Standard Deviation 1.12
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 1
Change at week 24
|
-2.13 units on a scale
Standard Deviation 1.09
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Here, "number analyzed" signifies participants evaluable at specific time points.
ASDAS: score combining assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on VAS ranging 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0\<= ASDAS-CRP \<1.3; moderate disease activity: 1.3\<= ASDAS-CRP \<2.1; high disease activity: 2.1\<= ASDAS-CRP \<=3.5; very high disease activity: 3.5\< ASDAS-CRP. The ASDAS-CRP is calculated with the following equation: 0.121\*total back pain+0.110\*participant global+0.073\*peripheral pain/swelling+0.058\*duration of morning stiffness+0.579\*Ln(CRP+1), Ln represents the natural logarithm.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 2
Period 2 Baseline
|
0.90 units on a scale
Standard Deviation 0.20
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 2
Change at Week 28 from Period 1 Baseline
|
-1.83 units on a scale
Standard Deviation 1.14
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 2
Change at Week 28 from Period 2 Baseline
|
0.66 units on a scale
Standard Deviation 0.89
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 2
Change at Week 32 from Period 1 Baseline
|
-1.76 units on a scale
Standard Deviation 1.09
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 2
Change at Week 32 from Period 2 Baseline
|
0.77 units on a scale
Standard Deviation 0.93
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 2
Change at Week 40 from Period 1 Baseline
|
-1.65 units on a scale
Standard Deviation 1.09
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 2
Change at Week 40 from Period 2 Baseline
|
0.74 units on a scale
Standard Deviation 0.90
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 2
Change at Week 48 from Period 1 Baseline
|
-1.59 units on a scale
Standard Deviation 1.05
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 2
Change at Week 48 from Period 2 Baseline
|
0.78 units on a scale
Standard Deviation 0.91
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 2
Change at Week 56 from Period 1 Baseline
|
-1.68 units on a scale
Standard Deviation 1.04
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 2
Change at Week 56 from Period 2 Baseline
|
0.63 units on a scale
Standard Deviation 0.83
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 2
Change at Week 64 from Period 1 Baseline
|
-1.46 units on a scale
Standard Deviation 1.08
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 2
Change at Week 64 from Period 2 Baseline
|
0.74 units on a scale
Standard Deviation 1.02
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Here, "number analyzed" signifies participants evaluable at specific time points.
ASDAS: score combining assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on VAS ranging 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0\<= ASDAS-CRP \<1.3; moderate disease activity: 1.3\<= ASDAS-CRP \<2.1; high disease activity: 2.1\<= ASDAS-CRP \<=3.5; very high disease activity: 3.5\< ASDAS-CRP. The ASDAS-CRP is calculated with the following equation: 0.121\*total back pain+0.110\*participant global+0.073\*peripheral pain/swelling+0.058\*duration of morning stiffness+0.579\*Ln(CRP+1), Ln represents the natural logarithm.
Outcome measures
| Measure |
Etanercept
n=87 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 3
Period 3 Baseline
|
2.97 units on a scale
Standard Deviation 0.91
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 3
Change at Week 64 from Period 1 baseline
|
-0.44 units on a scale
Standard Deviation 1.45
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 3
Change at Week 64 from Period 2 baseline
|
2.08 units on a scale
Standard Deviation 0.80
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 3
Change at Week 64 from Period 3 baseline
|
0.23 units on a scale
Standard Deviation 0.68
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 3
Change at Week 68 from Period 1 baseline
|
-1.94 units on a scale
Standard Deviation 1.05
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 3
Change at Week 68 from Period 2 baseline
|
0.65 units on a scale
Standard Deviation 0.69
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 3
Change at Week 68 from Period 3 baseline
|
-1.43 units on a scale
Standard Deviation 0.97
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 3
Change at Week 72 from Period 1 baseline
|
-2.11 units on a scale
Standard Deviation 1.00
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 3
Change at Week 72 from Period 2 baseline
|
0.47 units on a scale
Standard Deviation 0.65
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 3
Change at Week 72 from Period 3 baseline
|
-1.61 units on a scale
Standard Deviation 0.97
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 3
Change at Week 76 from Period 1 baseline
|
-2.17 units on a scale
Standard Deviation 1.03
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 3
Change at Week 76 from Period 2 baseline
|
0.45 units on a scale
Standard Deviation 0.64
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 3
Change at Week 76 from Period 3 baseline
|
-1.65 units on a scale
Standard Deviation 1.02
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0 = no disease activity and 100= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS-ESR was calculated with the following equation: 0.8\*total back pain+0.11\*participant global+0.09\*peripheral pain/swelling+0.07\*duration of morning stiffness+ 0.29\*ESR\^1/2. ASDAS ranged as inactive disease: 0 \<= ASDAS-ESR \<1.3; active disease: 1.3 \<= ASDAS-ESR =\<2.1.
Outcome measures
| Measure |
Etanercept
n=209 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 1
Baseline
|
3.59 units on a scale
Standard Deviation 0.90
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 1
Change at week 4
|
-1.27 units on a scale
Standard Deviation 0.98
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 1
Change at week 8
|
-1.56 units on a scale
Standard Deviation 1.08
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 1
Change at week 12
|
-1.70 units on a scale
Standard Deviation 1.15
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 1
Change at week 16
|
-1.81 units on a scale
Standard Deviation 1.12
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 1
Change at week 24
|
-2.05 units on a scale
Standard Deviation 1.17
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0 = no disease activity and 100= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS-ESR was calculated with the following equation: 0.8\*total back pain+0.11\*participant global+0.09\*peripheral pain/swelling+0.07\*duration of morning stiffness+ 0.29\*ESR\^1/2. ASDAS ranged as inactive disease: 0 \<= ASDAS-ESR \<1.3; active disease: 1.3 \<= ASDAS-ESR =\<2.1.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 2
Period 2 Baseline
|
0.92 units on a scale
Standard Deviation 0.37
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 2
Change at Week 28 from Period 1 Baseline
|
-1.81 units on a scale
Standard Deviation 1.17
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 2
Change at Week 28 from Period 2 Baseline
|
0.68 units on a scale
Standard Deviation 0.90
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 2
Change at Week 32 from Period 1 Baseline
|
-1.58 units on a scale
Standard Deviation 1.22
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 2
Change at Week 32 from Period 2 Baseline
|
0.93 units on a scale
Standard Deviation 1.03
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 2
Change at Week 40 from Period 1 Baseline
|
-1.34 units on a scale
Standard Deviation 1.23
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 2
Change at Week 40 from Period 2 Baseline
|
1.17 units on a scale
Standard Deviation 1.05
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 1 Baseline
|
-1.16 units on a scale
Standard Deviation 1.22
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 2 Baseline
|
1.34 units on a scale
Standard Deviation 1.05
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 2
Change at Week 56 from Period 1 Baseline
|
-1.11 units on a scale
Standard Deviation 1.22
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 2
Change at Week 56 from Period 2 Baseline
|
1.40 units on a scale
Standard Deviation 1.07
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 1 Baseline
|
-0.98 units on a scale
Standard Deviation 1.21
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 2 Baseline
|
1.52 units on a scale
Standard Deviation 1.12
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0 = no disease activity and 100= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS-ESR was calculated with the following equation: 0.8\*total back pain+0.11\*participant global+0.09\*peripheral pain/swelling+0.07\*duration of morning stiffness+ 0.29\*ESR\^1/2. ASDAS ranged as inactive disease: 0 \<= ASDAS-ESR \<1.3; active disease: 1.3 \<= ASDAS-ESR =\<2.1.
Outcome measures
| Measure |
Etanercept
n=87 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 3
Period 3 Baseline
|
3.15 units on a scale
Standard Deviation 0.72
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 1 Baseline
|
-0.54 units on a scale
Standard Deviation 1.50
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 2 Baseline
|
2.05 units on a scale
Standard Deviation 0.84
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 3 Baseline
|
0.10 units on a scale
Standard Deviation 0.71
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 3
Change at Week 68 from Period 1 Baseline
|
-1.97 units on a scale
Standard Deviation 1.01
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 3
Change at Week 68 from Period 2 Baseline
|
0.65 units on a scale
Standard Deviation 0.77
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 3
Change at Week 68 from Period 3 Baseline
|
-1.60 units on a scale
Standard Deviation 0.85
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 3
Change at Week 72 from Period 1 Baseline
|
-2.15 units on a scale
Standard Deviation 1.05
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 3
Change at Week 72 from Period 2 Baseline
|
0.46 units on a scale
Standard Deviation 0.74
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 3
Change at Week 72 from Period 3 Baseline
|
-1.77 units on a scale
Standard Deviation 0.87
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 1 Baseline
|
-2.21 units on a scale
Standard Deviation 1.09
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 2 Baseline
|
0.41 units on a scale
Standard Deviation 0.64
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 3 Baseline
|
-1.83 units on a scale
Standard Deviation 0.90
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Here, "number analyzed" signifies participants evaluable at specific time points.
ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0 = no disease activity and 100= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS-ESR was calculated with the following equation: 0.8\*total back pain+0.11\*participant global+0.09\*peripheral pain/swelling+0.07\*duration of morning stiffness+ 0.29\*ESR\^1/2. ASDAS ranged as inactive disease: 0 \<= ASDAS-ESR \<1.3; active disease: 1.3 \<= ASDAS-ESR =\<2.1.
Outcome measures
| Measure |
Etanercept
n=209 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 1
Baseline
|
3.59 units on a scale
Standard Deviation 0.90
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 1
Change at week 4
|
-1.27 units on a scale
Standard Deviation 0.98
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 1
Change at week 8
|
-1.57 units on a scale
Standard Deviation 1.09
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 1
Change at week 12
|
-1.75 units on a scale
Standard Deviation 1.16
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 1
Change at week 16
|
-1.89 units on a scale
Standard Deviation 1.11
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 1
Change at week 24
|
-2.16 units on a scale
Standard Deviation 1.12
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Here, "number analyzed" signifies participants evaluable at specific time points.
ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0 = no disease activity and 100= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS-ESR was calculated with the following equation: 0.8\*total back pain+0.11\*participant global+0.09\*peripheral pain/swelling+0.07\*duration of morning stiffness+ 0.29\*ESR\^1/2. ASDAS ranged as inactive disease: 0 \<= ASDAS-ESR \<1.3; active disease: 1.3 \<= ASDAS-ESR =\<2.1.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 2
Period 2 Baseline
|
0.92 units on a scale
Standard Deviation 0.37
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 2
Change at Week 28 from Period 1 Baseline
|
-1.81 units on a scale
Standard Deviation 1.17
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 2
Change at Week 28 from Period 2 Baseline
|
0.68 units on a scale
Standard Deviation 0.90
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 2
Change at Week 32 from Period 1 Baseline
|
-1.81 units on a scale
Standard Deviation 1.12
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 2
Change at Week 32 from Period 2 Baseline
|
0.70 units on a scale
Standard Deviation 0.90
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 2
Change at Week 40 from Period 1 Baseline
|
-1.59 units on a scale
Standard Deviation 1.13
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 2
Change at Week 40 from Period 2 Baseline
|
0.77 units on a scale
Standard Deviation 0.91
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 2
Change at Week 48 from Period 1 Baseline
|
-1.58 units on a scale
Standard Deviation 1.11
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 2
Change at Week 48 from Period 2 Baseline
|
0.81 units on a scale
Standard Deviation 1.01
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 2
Change at Week 56 from Period 1 Baseline
|
-1.71 units on a scale
Standard Deviation 1.04
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 2
Change at Week 56 from Period 2 Baseline
|
0.56 units on a scale
Standard Deviation 0.83
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 2
Change at Week 64 from Period 1 Baseline
|
-1.52 units on a scale
Standard Deviation 1.16
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 2
Change at Week 64 from Period 2 Baseline
|
0.73 units on a scale
Standard Deviation 1.23
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Here, "number analyzed" signifies participants evaluable at specific time points.
ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0 = no disease activity and 100= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS-ESR was calculated with the following equation: 0.8\*total back pain+0.11\*participant global+0.09\*peripheral pain/swelling+0.07\*duration of morning stiffness+ 0.29\*ESR\^1/2. ASDAS ranged as inactive disease: 0 \<= ASDAS-ESR \<1.3; active disease: 1.3 \<= ASDAS-ESR =\<2.1.
Outcome measures
| Measure |
Etanercept
n=87 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 3
Period 3 Baseline
|
3.15 units on a scale
Standard Deviation 0.72
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 3
Change at Week 64 from Period 1 Baseline
|
-0.54 units on a scale
Standard Deviation 1.50
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 3
Change at Week 64 from Period 2 Baseline
|
2.05 units on a scale
Standard Deviation 0.84
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 3
Change at Week 64 from Period 3 Baseline
|
0.10 units on a scale
Standard Deviation 0.71
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 3
Change at Week 68 from Period 1 Baseline
|
-1.99 units on a scale
Standard Deviation 1.01
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 3
Change at Week 68 from Period 2 Baseline
|
0.63 units on a scale
Standard Deviation 0.74
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 3
Change at Week 68 from Period 3 Baseline
|
-1.62 units on a scale
Standard Deviation 0.83
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 3
Change at Week 72 from Period 1 Baseline
|
-2.17 units on a scale
Standard Deviation 1.04
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 3
Change at Week 72 from Period 2 Baseline
|
0.43 units on a scale
Standard Deviation 0.69
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 3
Change at Week 72 from Period 3 Baseline
|
-1.80 units on a scale
Standard Deviation 0.84
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 3
Change at Week 76 from Period 1 Baseline
|
-2.22 units on a scale
Standard Deviation 1.07
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 3
Change at Week 76 from Period 2 Baseline
|
0.39 units on a scale
Standard Deviation 0.59
|
—
|
—
|
|
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 3
Change at Week 76 from Period 3 Baseline
|
-1.85 units on a scale
Standard Deviation 0.88
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4, 8, 12, 16, 24Population: FAS for Period 1 included all participants who took study medication and had one evaluation after baseline. Missing data was imputed using mixed LOCF. "Overall Number of Participants Analyzed" included participants who were evaluable for this outcome measure.
Major improvement in ASDAS-CRP was defined as decrease from baseline \>= 2.0 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121\*total back pain+0.110\*participant global+0.073\*peripheral pain/swelling+0.058\*duration of morning stiffness+0.579\*Ln(CRP+1), Ln represents the natural logarithm.
Outcome measures
| Measure |
Etanercept
n=208 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Last Observation Carried Forward (LOCF): Period 1
Week 4
|
26.0 percentage of participants
Interval 20.36 to 32.22
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Last Observation Carried Forward (LOCF): Period 1
Week 8
|
32.2 percentage of participants
Interval 26.14 to 38.77
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Last Observation Carried Forward (LOCF): Period 1
Week 12
|
36.1 percentage of participants
Interval 29.76 to 42.74
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Last Observation Carried Forward (LOCF): Period 1
Week 16
|
39.9 percentage of participants
Interval 33.43 to 46.66
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Last Observation Carried Forward (LOCF): Period 1
Week 24
|
49.0 percentage of participants
Interval 42.3 to 55.81
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 28, 32, 40, 48, 56, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
Major improvement in ASDAS-CRP was defined as decrease from baseline \>= 2.0 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121\*total back pain+0.110\*participant global+0.073\*peripheral pain/swelling+0.058\*duration of morning stiffness+0.579\*Ln(CRP+1), Ln represents the natural logarithm.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Last Observation Carried Forward (LOCF): Period 2
Week 28
|
43.6 percentage of participants
Interval 34.63 to 52.97
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Last Observation Carried Forward (LOCF): Period 2
Week 32
|
34.5 percentage of participants
Interval 26.23 to 43.58
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Last Observation Carried Forward (LOCF): Period 2
Week 40
|
30.1 percentage of participants
Interval 22.22 to 38.97
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Last Observation Carried Forward (LOCF): Period 2
Week 48
|
25.7 percentage of participants
Interval 18.3 to 34.26
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Last Observation Carried Forward (LOCF): Period 2
Week 56
|
22.1 percentage of participants
Interval 15.24 to 30.42
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Last Observation Carried Forward (LOCF): Period 2
Week 64
|
18.6 percentage of participants
Interval 12.25 to 26.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 64, 68, 72, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
Major improvement in ASDAS-CRP was defined as decrease from baseline \>= 2.0 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121\*total back pain+0.110\*participant global+0.073\*peripheral pain/swelling+0.058\*duration of morning stiffness+0.579\*Ln(CRP+1), Ln represents the natural logarithm.
Outcome measures
| Measure |
Etanercept
n=87 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Last Observation Carried Forward (LOCF): Period 3
Week 64
|
6.7 percentage of participants
Interval 0.73 to 27.18
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Last Observation Carried Forward (LOCF): Period 3
Week 68
|
41.2 percentage of participants
Interval 31.15 to 51.79
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Last Observation Carried Forward (LOCF): Period 3
Week 72
|
55.2 percentage of participants
Interval 44.7 to 65.31
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Last Observation Carried Forward (LOCF): Period 3
Week 76
|
54.0 percentage of participants
Interval 43.56 to 64.22
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4, 8, 12, 16, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Here, "Overall Number of Participants Analyzed" signifies participants evaluable at this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
Major improvement in ASDAS-CRP was defined as decrease from baseline \>= 2.0 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121\*total back pain+0.110\*participant global+0.073\*peripheral pain/swelling+0.058\*duration of morning stiffness+0.579\*Ln(CRP+1), Ln represents the natural logarithm.
Outcome measures
| Measure |
Etanercept
n=208 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Observed Cases (OC): Period 1
Week 4
|
26.0 percentage of participants
Interval 20.36 to 32.22
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Observed Cases (OC): Period 1
Week 8
|
32.8 percentage of participants
Interval 26.62 to 39.54
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Observed Cases (OC): Period 1
Week 12
|
38.1 percentage of participants
Interval 31.5 to 44.99
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Observed Cases (OC): Period 1
Week 16
|
42.4 percentage of participants
Interval 35.56 to 49.49
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Observed Cases (OC): Period 1
Week 24
|
52.6 percentage of participants
Interval 45.54 to 59.65
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 28, 32, 40, 48, 56, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Here, "number analyzed" signifies participants evaluable at specific time points.
Major improvement in ASDAS-CRP was defined as decrease from baseline \>= 2.0 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121\*total back pain+0.110\*participant global+0.073\*peripheral pain/swelling+0.058\*duration of morning stiffness+0.579\*Ln(CRP+1), Ln represents the natural logarithm.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Observed Cases (OC): Period 2
Week 28
|
43.6 percentage of participants
Interval 34.63 to 52.97
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Observed Cases (OC): Period 2
Week 32
|
39.8 percentage of participants
Interval 30.27 to 49.92
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Observed Cases (OC): Period 2
Week 40
|
37.9 percentage of participants
Interval 26.9 to 49.9
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Observed Cases (OC): Period 2
Week 48
|
34.0 percentage of participants
Interval 22.06 to 47.74
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Observed Cases (OC): Period 2
Week 56
|
31.7 percentage of participants
Interval 19.08 to 46.82
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Observed Cases (OC): Period 2
Week 64
|
23.5 percentage of participants
Interval 11.8 to 39.55
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 64, 68, 72, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Here, "number analyzed" signifies participants evaluable at specific time points.
Major improvement in ASDAS-CRP was defined as decrease from baseline \>= 2.0 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121\*total back pain+0.110\*participant global+0.073\*peripheral pain/swelling+0.058\*duration of morning stiffness+0.579\*Ln(CRP+1), Ln represents the natural logarithm.
Outcome measures
| Measure |
Etanercept
n=87 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Observed Cases (OC): Period 3
Week 64
|
6.7 percentage of participants
Interval 0.73 to 27.18
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Observed Cases (OC): Period 3
Week 68
|
41.7 percentage of participants
Interval 31.55 to 52.34
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Observed Cases (OC): Period 3
Week 72
|
55.8 percentage of participants
Interval 45.27 to 65.97
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Observed Cases (OC): Period 3
Week 76
|
55.3 percentage of participants
Interval 44.7 to 65.54
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4, 8, 12, 16, 24Population: FAS for Period 1 included all participants who took study medication and had one evaluation after baseline. Missing data was imputed using mixed LOCF. "Overall Number of Participants Analyzed" included participants who were evaluable for this outcome measure.
ASDAS-CRP clinically important improvement was defined as a decrease from baseline of \>=1.1 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121\*total back pain+0.110\* participant global+0.073\*peripheral pain/swelling+0.058\*duration of morning stiffness+0.579\*Ln (CRP+1), Ln represents the natural logarithm.
Outcome measures
| Measure |
Etanercept
n=208 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Last Observation Carried Forward (LOCF): Period 1
Week 24
|
77.4 percentage of participants
Interval 71.37 to 82.68
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Last Observation Carried Forward (LOCF): Period 1
Week 4
|
55.8 percentage of participants
Interval 48.98 to 62.4
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Last Observation Carried Forward (LOCF): Period 1
Week 8
|
64.4 percentage of participants
Interval 57.75 to 70.69
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Last Observation Carried Forward (LOCF): Period 1
Week 12
|
63.9 percentage of participants
Interval 57.26 to 70.24
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Last Observation Carried Forward (LOCF): Period 1
Week 16
|
71.6 percentage of participants
Interval 65.24 to 77.43
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 28, 32, 40, 48, 56, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
ASDAS-CRP clinically important improvement was defined as a decrease from baseline of \>=1.1 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121\*total back pain+0.110\* participant global+0.073\*peripheral pain/swelling+0.058\*duration of morning stiffness+0.579\*Ln (CRP+1), Ln represents the natural logarithm.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Last Observation Carried Forward (LOCF): Period 2
Week 28
|
74.5 percentage of participants
Interval 65.84 to 81.98
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Last Observation Carried Forward (LOCF): Period 2
Week 32
|
70.8 percentage of participants
Interval 61.97 to 78.58
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Last Observation Carried Forward (LOCF): Period 2
Week 40
|
59.3 percentage of participants
Interval 50.09 to 68.02
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Last Observation Carried Forward (LOCF): Period 2
Week 48
|
55.8 percentage of participants
Interval 46.55 to 64.67
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Last Observation Carried Forward (LOCF): Period 2
Week 56
|
54.9 percentage of participants
Interval 45.67 to 63.82
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Last Observation Carried Forward (LOCF): Period 2
Week 64
|
50.4 percentage of participants
Interval 41.31 to 59.55
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 64, 68, 72, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
ASDAS-CRP clinically important improvement was defined as a decrease from baseline of \>=1.1 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121\*total back pain+0.110\* participant global+0.073\*peripheral pain/swelling+0.058\*duration of morning stiffness+0.579\*Ln (CRP+1), Ln represents the natural logarithm.
Outcome measures
| Measure |
Etanercept
n=87 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Last Observation Carried Forward (LOCF): Period 3
Week 64
|
26.7 percentage of participants
Interval 9.74 to 51.66
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Last Observation Carried Forward (LOCF): Period 3
Week 68
|
80.0 percentage of participants
Interval 70.58 to 87.42
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Last Observation Carried Forward (LOCF): Period 3
Week 72
|
82.8 percentage of participants
Interval 73.82 to 89.56
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Last Observation Carried Forward (LOCF): Period 3
Week 76
|
79.3 percentage of participants
Interval 69.93 to 86.78
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4, 8, 12, 16, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Here, "Overall Number of Participants Analyzed" signifies participants evaluable at this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
ASDAS-CRP clinically important improvement was defined as a decrease from baseline of \>=1.1 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121\*total back pain+0.110\* participant global+0.073\*peripheral pain/swelling+0.058\*duration of morning stiffness+0.579\*Ln (CRP+1), Ln represents the natural logarithm.
Outcome measures
| Measure |
Etanercept
n=208 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Observed Cases (OC): Period 1
Week 4
|
55.8 percentage of participants
Interval 48.98 to 62.4
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Observed Cases (OC): Period 1
Week 8
|
64.7 percentage of participants
Interval 57.9 to 71.04
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Observed Cases (OC): Period 1
Week 12
|
65.5 percentage of participants
Interval 58.66 to 71.86
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Observed Cases (OC): Period 1
Week 16
|
74.3 percentage of participants
Interval 67.82 to 80.14
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Observed Cases (OC): Period 1
Week 24
|
81.1 percentage of participants
Interval 75.04 to 86.13
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 28, 32, 40, 48, 56, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Here, "number analyzed" signifies participants evaluable at specific time points.
ASDAS-CRP clinically important improvement was defined as a decrease from baseline of \>=1.1 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121\*total back pain+0.110\* participant global+0.073\*peripheral pain/swelling+0.058\*duration of morning stiffness+0.579\*Ln (CRP+1), Ln represents the natural logarithm.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Observed Cases (OC): Period 2
Week 28
|
74.5 percentage of participants
Interval 65.84 to 81.98
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Observed Cases (OC): Period 2
Week 32
|
79.6 percentage of participants
Interval 70.55 to 86.79
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Observed Cases (OC): Period 2
Week 40
|
68.2 percentage of participants
Interval 56.35 to 78.46
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Observed Cases (OC): Period 2
Week 48
|
72.0 percentage of participants
Interval 58.58 to 82.96
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Observed Cases (OC): Period 2
Week 56
|
78.0 percentage of participants
Interval 63.75 to 88.55
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Observed Cases (OC): Period 2
Week 64
|
70.6 percentage of participants
Interval 54.07 to 83.77
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 64, 68, 72, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Here, "number analyzed" signifies participants evaluable at specific time points.
ASDAS-CRP clinically important improvement was defined as a decrease from baseline of \>=1.1 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121\*total back pain+0.110\* participant global+0.073\*peripheral pain/swelling+0.058\*duration of morning stiffness+0.579\*Ln (CRP+1), Ln represents the natural logarithm.
Outcome measures
| Measure |
Etanercept
n=87 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Observed Cases (OC): Period 3
Week 64
|
26.7 percentage of participants
Interval 9.74 to 51.66
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Observed Cases (OC): Period 3
Week 68
|
81.0 percentage of participants
Interval 71.59 to 88.23
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Observed Cases (OC): Period 3
Week 72
|
83.7 percentage of participants
Interval 74.87 to 90.35
|
—
|
—
|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Observed Cases (OC): Period 3
Week 76
|
81.2 percentage of participants
Interval 71.9 to 88.37
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
Participants assessed their nocturnal back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to centimeter (cm) for analysis.
Outcome measures
| Measure |
Etanercept
n=209 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 1
Baseline
|
5.92 cm
Standard Deviation 2.52
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 1
Change at week 4
|
-2.53 cm
Standard Deviation 2.55
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 1
Change at week 8
|
-3.10 cm
Standard Deviation 2.76
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 1
Change at week 12
|
-3.25 cm
Standard Deviation 2.76
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 1
Change at week 16
|
-3.55 cm
Standard Deviation 2.67
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 1
Change at week 24
|
-4.14 cm
Standard Deviation 2.88
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
Participants assessed their nocturnal back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 2
Change at Week 32 from Period 2 Baseline
|
1.80 cm
Standard Deviation 2.65
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 2 Baseline
|
2.53 cm
Standard Deviation 2.93
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 2
Period 2 Baseline
|
0.63 cm
Standard Deviation 1.07
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 2
Change at Week 28 from Period 1 Baseline
|
-3.77 cm
Standard Deviation 3.20
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 2
Change at Week 28 from Period 2 Baseline
|
1.08 cm
Standard Deviation 2.33
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 2
Change at Week 32 from Period 1 Baseline
|
-3.05 cm
Standard Deviation 3.07
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 2
Change at Week 40 from Period 1 Baseline
|
-2.64 cm
Standard Deviation 3.13
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 2
Change at Week 40 from Period 2 Baseline
|
2.22 cm
Standard Deviation 2.89
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 1 Baseline
|
-2.32 cm
Standard Deviation 3.26
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 2
Change at Week 56 from Period 1 Baseline
|
-2.11 cm
Standard Deviation 3.14
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 2
Change at Week 56 from Period 2 Baseline
|
2.74 cm
Standard Deviation 3.00
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 1 Baseline
|
-1.77 cm
Standard Deviation 3.14
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 2 Baseline
|
3.08 cm
Standard Deviation 3.06
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
Participants assessed their nocturnal back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis.
Outcome measures
| Measure |
Etanercept
n=87 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 3
Period 3 Baseline
|
5.54 cm
Standard Deviation 2.63
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 1 Baseline
|
-0.28 cm
Standard Deviation 4.01
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 2 Baseline
|
4.35 cm
Standard Deviation 2.87
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 3 Baseline
|
1.29 cm
Standard Deviation 3.36
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 3
Change at Week 68 from Period 1 Baseline
|
-4.03 cm
Standard Deviation 2.81
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 3
Change at Week 68 from Period 2 Baseline
|
1.33 cm
Standard Deviation 1.92
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 3
Change at Week 68 from Period 3 Baseline
|
-3.59 cm
Standard Deviation 2.64
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 3
Change at Week 72 from Period 1 Baseline
|
-4.43 cm
Standard Deviation 2.70
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 3
Change at Week 72 from Period 2 Baseline
|
0.94 cm
Standard Deviation 1.87
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 3
Change at Week 72 from Period 3 Baseline
|
-3.96 cm
Standard Deviation 2.64
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 1 Baseline
|
-4.72 cm
Standard Deviation 2.82
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 2 Baseline
|
0.64 cm
Standard Deviation 1.51
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 3 Baseline
|
-4.25 cm
Standard Deviation 2.74
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Here, "number analyzed" signifies participants evaluable at specific time points.
Participants assessed their nocturnal back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis.
Outcome measures
| Measure |
Etanercept
n=209 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 1
Baseline
|
5.92 cm
Standard Deviation 2.52
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 1
Change at week 4
|
-2.53 cm
Standard Deviation 2.55
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 1
Change at week 8
|
-3.10 cm
Standard Deviation 2.79
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 1
Change at week 12
|
-3.32 cm
Standard Deviation 2.78
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 1
Change at week 16
|
-3.68 cm
Standard Deviation 2.68
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 1
Change at week 24
|
-4.32 cm
Standard Deviation 2.87
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Here, "number analyzed" signifies participants evaluable at specific time points.
Participants assessed their nocturnal back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 2
Change at Week 40 from Period 2 Baseline
|
1.46 cm
Standard Deviation 2.67
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 2
Period 2 Baseline
|
0.63 cm
Standard Deviation 1.07
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 2
Change at Week 28 from Period 1 Baseline
|
-3.77 cm
Standard Deviation 3.20
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 2
Change at Week 28 from Period 2 Baseline
|
1.08 cm
Standard Deviation 2.33
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 2
Change at Week 32 from Period 1 Baseline
|
-3.50 cm
Standard Deviation 2.61
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 2
Change at Week 32 from Period 2 Baseline
|
1.33 cm
Standard Deviation 2.38
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 2
Change at Week 40 from Period 1 Baseline
|
-3.12 cm
Standard Deviation 2.79
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 2
Change at Week 48 from Period 1 Baseline
|
-3.03 cm
Standard Deviation 3.02
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 2
Change at Week 48 from Period 2 Baseline
|
1.52 cm
Standard Deviation 2.73
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 2
Change at Week 56 from Period 1 Baseline
|
-3.22 cm
Standard Deviation 2.53
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 2
Change at Week 56 from Period 2 Baseline
|
1.24 cm
Standard Deviation 2.69
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 2
Change at Week 64 from Period 1 Baseline
|
-2.28 cm
Standard Deviation 2.77
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 2
Change at Week 64 from Period 2 Baseline
|
1.53 cm
Standard Deviation 3.01
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Here, "number analyzed" signifies participants evaluable at specific time points.
Participants assessed their nocturnal back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis.
Outcome measures
| Measure |
Etanercept
n=87 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 3
Period 3 Baseline
|
5.54 cm
Standard Deviation 2.63
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 3
Change at Week 64 from Period 1 Baseline
|
-0.28 cm
Standard Deviation 4.01
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 3
Change at Week 64 from Period 2 Baseline
|
4.35 cm
Standard Deviation 2.87
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 3
Change at Week 64 from Period 3 Baseline
|
1.29 cm
Standard Deviation 3.36
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 3
Change at Week 68 from Period 1 Baseline
|
-4.07 cm
Standard Deviation 2.81
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 3
Change at Week 68 from Period 2 Baseline
|
1.34 cm
Standard Deviation 1.93
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 3
Change at Week 68 from Period 3 Baseline
|
-3.62 cm
Standard Deviation 2.64
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 3
Change at Week 72 from Period 1 Baseline
|
-4.43 cm
Standard Deviation 2.70
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 3
Change at Week 72 from Period 2 Baseline
|
0.94 cm
Standard Deviation 1.87
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 3
Change at Week 72 from Period 3 Baseline
|
-3.96 cm
Standard Deviation 2.64
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 3
Change at Week 76 from Period 1 Baseline
|
-4.84 cm
Standard Deviation 2.75
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 3
Change at Week 76 from Period 2 Baseline
|
0.64 cm
Standard Deviation 1.51
|
—
|
—
|
|
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 3
Change at Week 76 from Period 3 Baseline
|
-4.36 cm
Standard Deviation 2.68
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
Participants assessed their total back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis.
Outcome measures
| Measure |
Etanercept
n=209 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 1
Baseline
|
5.98 cm
Standard Deviation 2.41
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 1
Change at week 4
|
-2.39 cm
Standard Deviation 2.36
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 1
Change at week 8
|
-2.96 cm
Standard Deviation 2.54
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 1
Change at week 12
|
-3.15 cm
Standard Deviation 2.60
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 1
Change at week 16
|
-3.44 cm
Standard Deviation 2.54
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 1
Change at week 24
|
-4.05 cm
Standard Deviation 2.79
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
Participants assessed their total back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 2
Period 2 Baseline
|
0.71 cm
Standard Deviation 1.09
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 2
Change at Week 28 from Period 1 Baseline
|
-3.68 cm
Standard Deviation 3.04
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 2
Change at Week 28 from Period 2 Baseline
|
1.09 cm
Standard Deviation 2.20
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 2
Change at Week 32 from Period 1 Baseline
|
-2.92 cm
Standard Deviation 3.06
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 2
Change at Week 32 from Period 2 Baseline
|
1.84 cm
Standard Deviation 2.58
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 2
Change at Week 40 from Period 1 Baseline
|
-2.48 cm
Standard Deviation 3.17
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 2
Change at Week 40 from Period 2 Baseline
|
2.28 cm
Standard Deviation 2.87
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 1 Baseline
|
-2.12 cm
Standard Deviation 3.19
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 2 Baseline
|
2.64 cm
Standard Deviation 2.90
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 2
Change at Week 56 from Period 1 Baseline
|
-1.95 cm
Standard Deviation 3.16
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 2
Change at Week 56 from Period 2 Baseline
|
2.81 cm
Standard Deviation 2.96
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 1 Baseline
|
-1.66 cm
Standard Deviation 3.13
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 2 Baseline
|
3.10 cm
Standard Deviation 3.02
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
Participants assessed their total back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis.
Outcome measures
| Measure |
Etanercept
n=87 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 3
Change at Week 68 from Period 3 Baseline
|
-3.60 cm
Standard Deviation 2.55
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 3
Period 3 Baseline
|
5.66 cm
Standard Deviation 2.55
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 1 Baseline
|
-0.10 cm
Standard Deviation 4.08
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 2 Baseline
|
4.34 cm
Standard Deviation 2.70
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 3 Baseline
|
1.07 cm
Standard Deviation 2.88
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 3
Change at Week 68 from Period 1 Baseline
|
-3.73 cm
Standard Deviation 2.66
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 3
Change at Week 68 from Period 2 Baseline
|
1.35 cm
Standard Deviation 1.96
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 3
Change at Week 72 from Period 1 Baseline
|
-4.21 cm
Standard Deviation 2.42
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 3
Change at Week 72 from Period 2 Baseline
|
0.89 cm
Standard Deviation 1.81
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 3
Change at Week 72 from Period 3 Baseline
|
-4.03 cm
Standard Deviation 2.50
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 1 Baseline
|
-4.32 cm
Standard Deviation 2.70
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 2 Baseline
|
0.77 cm
Standard Deviation 1.52
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 3 Baseline
|
-4.15 cm
Standard Deviation 2.72
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Here, "number analyzed" signifies participants evaluable at specific time points.
Participants assessed their total back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis.
Outcome measures
| Measure |
Etanercept
n=209 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 1
Baseline
|
5.98 cm
Standard Deviation 2.41
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 1
Change at week 4
|
-2.39 cm
Standard Deviation 2.36
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 1
Change at week 8
|
-2.97 cm
Standard Deviation 2.56
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 1
Change at week 12
|
-3.23 cm
Standard Deviation 2.62
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 1
Change at week 16
|
-3.56 cm
Standard Deviation 2.53
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 1
Change at week 24
|
-4.24 cm
Standard Deviation 2.75
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Here, "number analyzed" signifies participants evaluable at specific time points.
Participants assessed their total back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 2
Period 2 Baseline
|
0.71 cm
Standard Deviation 1.09
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 2
Change at Week 28 from Period 1 Baseline
|
-3.68 cm
Standard Deviation 3.04
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 2
Change at Week 28 from Period 2 Baseline
|
1.09 cm
Standard Deviation 2.20
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 2
Change at Week 32 from Period 1 Baseline
|
-3.43 cm
Standard Deviation 2.67
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 2
Change at Week 32 from Period 2 Baseline
|
1.38 cm
Standard Deviation 2.35
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 2
Change at Week 40 from Period 1 Baseline
|
-2.97 cm
Standard Deviation 2.81
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 2
Change at Week 40 from Period 2 Baseline
|
1.52 cm
Standard Deviation 2.69
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 2
Change at Week 48 from Period 1 Baseline
|
-2.91 cm
Standard Deviation 2.78
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 2
Change at Week 48 from Period 2 Baseline
|
1.54 cm
Standard Deviation 2.65
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 2
Change at Week 56 from Period 1 Baseline
|
-3.15 cm
Standard Deviation 2.53
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 2
Change at Week 56 from Period 2 Baseline
|
1.15 cm
Standard Deviation 2.52
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 2
Change at Week 64 from Period 1 Baseline
|
-2.56 cm
Standard Deviation 2.73
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 2
Change at Week 64 from Period 2 Baseline
|
1.39 cm
Standard Deviation 2.96
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Here, "number analyzed" signifies participants evaluable at specific time points.
Participants assessed their total back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis.
Outcome measures
| Measure |
Etanercept
n=87 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 3
Period 3 Baseline
|
5.66 cm
Standard Deviation 2.55
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 3
Change at Week 64 from Period 1 Baseline
|
-0.10 cm
Standard Deviation 4.08
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 3
Change at Week 64 from Period 2 Baseline
|
4.34 cm
Standard Deviation 2.70
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 3
Change at Week 64 from Period 3 Baseline
|
1.07 cm
Standard Deviation 2.88
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 3
Change at Week 68 from Period 1 Baseline
|
-3.76 cm
Standard Deviation 2.67
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 3
Change at Week 68 from Period 2 Baseline
|
1.35 cm
Standard Deviation 1.97
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 3
Change at Week 68 from Period 3 Baseline
|
-3.63 cm
Standard Deviation 2.54
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 3
Change at Week 72 from Period 1 Baseline
|
-4.21 cm
Standard Deviation 2.42
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 3
Change at Week 72 from Period 2 Baseline
|
0.89 cm
Standard Deviation 1.81
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 3
Change at Week 72 from Period 3 Baseline
|
-4.03 cm
Standard Deviation 2.50
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 3
Change at Week 76 from Period 1 Baseline
|
-4.41 cm
Standard Deviation 2.67
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 3
Change at Week 76 from Period 2 Baseline
|
0.78 cm
Standard Deviation 1.53
|
—
|
—
|
|
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 3
Change at Week 76 from Period 3 Baseline
|
-4.24 cm
Standard Deviation 2.69
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Here, "number analyzed" signifies participants evaluable at specific time points.
BASFI is composed of 10 questions related to the participant's ability to function. Each question scored by the participant on a 100 mm scale ranging from 0 (easy) to 100 (impossible), where higher scores indicated more difficulty in participant's ability to function. The BASFI total score calculated as mean of the scores for these 10 questions and converted to cm for analysis. BASFI total score was ranged from 0 (easy) to 10 (impossible), where higher scores indicated more difficulty in participant's ability to function due to ankylosing spondylitis.
Outcome measures
| Measure |
Etanercept
n=209 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 1
Baseline
|
4.66 units on a scale
Standard Deviation 2.21
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 1
Change at week 4
|
-1.62 units on a scale
Standard Deviation 1.88
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 1
Change at week 8
|
-2.22 units on a scale
Standard Deviation 2.21
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 1
Change at week 12
|
-2.44 units on a scale
Standard Deviation 2.34
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 1
Change at week 16
|
-2.73 units on a scale
Standard Deviation 2.27
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 1
Change at week 24
|
-3.24 units on a scale
Standard Deviation 2.57
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Here, "number analyzed" signifies participants evaluable at specific time points.
BASFI is composed of 10 questions related to the participant's ability to function. Each question scored by the participant on a 100 mm scale ranging from 0 (easy) to 100 (impossible), where higher scores indicated more difficulty in participant's ability to function. The BASFI total score calculated as mean of the scores for these 10 questions and converted to cm for analysis. BASFI total score was ranged from 0 (easy) to 10 (impossible), where higher scores indicated more difficulty in participant's ability to function due to ankylosing spondylitis.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 2
Period 2 Baseline
|
0.59 units on a scale
Standard Deviation 0.88
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 2
Change at Week 28 from Period 1 Baseline
|
-3.00 units on a scale
Standard Deviation 2.78
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 2
Change at Week 28 from Period 2 Baseline
|
0.90 units on a scale
Standard Deviation 1.97
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 2
Change at Week 32 from Period 1 Baseline
|
-3.10 units on a scale
Standard Deviation 2.52
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 2
Change at Week 32 from Period 2 Baseline
|
0.88 units on a scale
Standard Deviation 1.86
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 2
Change at Week 40 from Period 1 Baseline
|
-2.88 units on a scale
Standard Deviation 2.41
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 2
Change at Week 40 from Period 2 Baseline
|
0.98 units on a scale
Standard Deviation 1.63
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 2
Change at Week 48 from Period 1 Baseline
|
-2.84 units on a scale
Standard Deviation 2.37
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 2
Change at Week 48 from Period 2 Baseline
|
0.98 units on a scale
Standard Deviation 1.76
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 2
Change at Week 56 from Period 1 Baseline
|
-2.97 units on a scale
Standard Deviation 2.14
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 2
Change at Week 56 from Period 2 Baseline
|
0.73 units on a scale
Standard Deviation 1.57
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 2
Change at Week 64 from Period 1 Baseline
|
-2.33 units on a scale
Standard Deviation 2.08
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 2
Change at Week 64 from Period 2 Baseline
|
1.21 units on a scale
Standard Deviation 2.41
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Here, "number analyzed" signifies participants evaluable at specific time points.
BASFI is composed of 10 questions related to the participant's ability to function. Each question scored by the participant on a 100 mm scale ranging from 0 (easy) to 100 (impossible), where higher scores indicated more difficulty in participant's ability to function. The BASFI total score calculated as mean of the scores for these 10 questions and converted to cm for analysis. BASFI total score was ranged from 0 (easy) to 10 (impossible), where higher scores indicated more difficulty in participant's ability to function due to ankylosing spondylitis.
Outcome measures
| Measure |
Etanercept
n=87 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 3
Period 3 Baseline
|
4.14 units on a scale
Standard Deviation 2.44
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 3
Change at Week 64 from Period 1 Baseline
|
-0.62 units on a scale
Standard Deviation 3.52
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 3
Change at Week 64 from Period 2 Baseline
|
3.11 units on a scale
Standard Deviation 2.16
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 3
Change at Week 64 from Period 3 Baseline
|
0.78 units on a scale
Standard Deviation 2.73
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 3
Change at Week 68 from Period 1 Baseline
|
-2.99 units on a scale
Standard Deviation 2.30
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 3
Change at Week 68 from Period 2 Baseline
|
1.13 units on a scale
Standard Deviation 1.58
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 3
Change at Week 68 from Period 3 Baseline
|
-2.41 units on a scale
Standard Deviation 2.00
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 3
Change at Week 72 from Period 1 Baseline
|
-3.25 units on a scale
Standard Deviation 2.35
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 3
Change at Week 72 from Period 2 Baseline
|
0.84 units on a scale
Standard Deviation 1.40
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 3
Change at Week 72 from Period 3 Baseline
|
-2.67 units on a scale
Standard Deviation 2.22
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 3
Change at Week 76 from Period 1 Baseline
|
-3.47 units on a scale
Standard Deviation 2.49
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 3
Change at Week 76 from Period 2 Baseline
|
0.67 units on a scale
Standard Deviation 1.30
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 3
Change at Week 76 from Period 3 Baseline
|
-2.89 units on a scale
Standard Deviation 2.23
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
BASFI is composed of 10 questions related to the participant's ability to function. Each question scored by the participant on a 100 mm scale ranging from 0 (easy) to 100 (impossible), where higher scores indicated more difficulty in participant's ability to function. The BASFI total score calculated as mean of the scores for these 10 questions and converted to cm for analysis. BASFI total score was ranged from 0 (easy) to 10 (impossible), where higher scores indicated more difficulty in participant's ability to function due to ankylosing spondylitis.
Outcome measures
| Measure |
Etanercept
n=209 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 1
Baseline
|
4.66 units on a scale
Standard Deviation 2.21
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 1
Change at week 4
|
-1.62 units on a scale
Standard Deviation 1.88
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 1
Change at week 8
|
-2.23 units on a scale
Standard Deviation 2.19
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 1
Change at week 12
|
-2.39 units on a scale
Standard Deviation 2.31
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 1
Change at week 16
|
-2.65 units on a scale
Standard Deviation 2.24
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 1
Change at week 24
|
-3.10 units on a scale
Standard Deviation 2.54
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2.Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
BASFI is composed of 10 questions related to the participant's ability to function. Each question scored by the participant on a 100 mm scale ranging from 0 (easy) to 100 (impossible), where higher scores indicated more difficulty in participant's ability to function. The BASFI total score calculated as mean of the scores for these 10 questions and converted to cm for analysis. BASFI total score was ranged from 0 (easy) to 10 (impossible), where higher scores indicated more difficulty in participant's ability to function due to ankylosing spondylitis.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 1 Baseline
|
-1.97 units on a scale
Standard Deviation 2.89
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 2
Period 2 Baseline
|
0.59 units on a scale
Standard Deviation 0.88
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 2
Change at Week 28 from Period 1 Baseline
|
-3.00 units on a scale
Standard Deviation 2.78
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 2
Change at Week 28 from Period 2 Baseline
|
0.90 units on a scale
Standard Deviation 1.97
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 2
Change at Week 32 from Period 1 Baseline
|
-2.54 units on a scale
Standard Deviation 2.88
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 2
Change at Week 32 from Period 2 Baseline
|
1.35 units on a scale
Standard Deviation 2.22
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 2
Change at Week 40 from Period 1 Baseline
|
-2.21 units on a scale
Standard Deviation 2.90
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 2
Change at Week 40 from Period 2 Baseline
|
1.67 units on a scale
Standard Deviation 2.29
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 2 Baseline
|
1.92 units on a scale
Standard Deviation 2.36
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 2
Change at Week 56 from Period 1 Baseline
|
-1.85 units on a scale
Standard Deviation 2.88
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 2
Change at Week 56 from Period 2 Baseline
|
2.03 units on a scale
Standard Deviation 2.40
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 1 Baseline
|
-1.62 units on a scale
Standard Deviation 2.84
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 2 Baseline
|
2.27 units on a scale
Standard Deviation 2.51
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
BASFI is composed of 10 questions related to the participant's ability to function. Each question scored by the participant on a 100 mm scale ranging from 0 (easy) to 100 (impossible), where higher scores indicated more difficulty in participant's ability to function. The BASFI total score calculated as mean of the scores for these 10 questions and converted to cm for analysis. BASFI total score was ranged from 0 (easy) to 10 (impossible), where higher scores indicated more difficulty in participant's ability to function due to ankylosing spondylitis.
Outcome measures
| Measure |
Etanercept
n=87 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 3
Change at Week 68 from Period 2 Baseline
|
1.14 units on a scale
Standard Deviation 1.57
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 3
Change at Week 68 from Period 3 Baseline
|
-2.38 units on a scale
Standard Deviation 2.01
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 3
Change at Week 72 from Period 1 Baseline
|
-3.25 units on a scale
Standard Deviation 2.35
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 3
Change at Week 72 from Period 2 Baseline
|
0.84 units on a scale
Standard Deviation 1.40
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 3
Change at Week 72 from Period 3 Baseline
|
-2.67 units on a scale
Standard Deviation 2.22
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 1 Baseline
|
-3.41 units on a scale
Standard Deviation 2.49
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 2 Baseline
|
0.68 units on a scale
Standard Deviation 1.29
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 3 Baseline
|
-2.83 units on a scale
Standard Deviation 2.24
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 3
Period 3 Baseline
|
4.14 units on a scale
Standard Deviation 2.44
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 1 Baseline
|
-0.62 units on a scale
Standard Deviation 3.52
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 2 Baseline
|
3.11 units on a scale
Standard Deviation 2.16
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 3 Baseline
|
0.78 units on a scale
Standard Deviation 2.73
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 3
Change at Week 68 from Period 1 Baseline
|
-2.98 units on a scale
Standard Deviation 2.29
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Here, "number analyzed" signifies participants evaluable at specific time points.
BASDAI consisted of 6 questions related to disease activity. Each of the first 5 questions was scored by the participant on a 100 mm scale ranging from 0 (none) to 100 (very severe), where higher scores indicated more severe disease activity. The sixth question, related to duration of morning stiffness measured on a scale for 0 (0 hours) to 100 (2 hours), where higher scores indicated larger duration of morning stiffness. The BASDAI score was obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 \[severity of morning stiffness\] and 6 \[duration of morning stiffness\]) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The BASDAI total score ranged from 0 to 10, where higher scores indicated more severe disease activity. The reported values were converted to cm for analysis.
Outcome measures
| Measure |
Etanercept
n=209 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 1
Baseline
|
6.41 units on a scale
Standard Deviation 1.80
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 1
Change at week 4
|
-2.39 units on a scale
Standard Deviation 1.93
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 1
Change at week 8
|
-3.08 units on a scale
Standard Deviation 2.17
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 1
Change at week 12
|
-3.40 units on a scale
Standard Deviation 2.37
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 1
Change at week 16
|
-3.91 units on a scale
Standard Deviation 2.31
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 1
Change at week 24
|
-4.65 units on a scale
Standard Deviation 2.36
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Here, "number analyzed" signifies participants evaluable at specific time points.
BASDAI consisted of 6 questions related to disease activity. Each of the first 5 questions was scored by the participant on a 100 mm scale ranging from 0 (none) to 100 (very severe), where higher scores indicated more severe disease activity. The sixth question, related to duration of morning stiffness measured on a scale for 0 (0 hours) to 100 (2 hours), where higher scores indicated larger duration of morning stiffness. The BASDAI score was obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 \[severity of morning stiffness\] and 6 \[duration of morning stiffness\]) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The BASDAI total score ranged from 0 to 10, where higher scores indicated more severe disease activity. The reported values were converted to cm for analysis.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 2
Period 2 Baseline
|
0.63 units on a scale
Standard Deviation 0.66
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 2
Change at Week 28 from Period 1 Baseline
|
-4.10 units on a scale
Standard Deviation 2.61
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 2
Change at Week 28 from Period 2 Baseline
|
1.38 units on a scale
Standard Deviation 2.27
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 2
Change at Week 32 from Period 1 Baseline
|
-4.11 units on a scale
Standard Deviation 2.40
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 2
Change at Week 32 from Period 2 Baseline
|
1.37 units on a scale
Standard Deviation 2.17
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 2
Change at Week 40 from Period 1 Baseline
|
-3.77 units on a scale
Standard Deviation 2.46
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 2
Change at Week 40 from Period 2 Baseline
|
1.60 units on a scale
Standard Deviation 2.35
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 2
Change at Week 48 from Period 1 Baseline
|
-3.78 units on a scale
Standard Deviation 2.32
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 2
Change at Week 48 from Period 2 Baseline
|
1.65 units on a scale
Standard Deviation 2.39
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 2
Change at Week 56 from Period 1 Baseline
|
-3.97 units on a scale
Standard Deviation 2.18
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 2
Change at Week 56 from Period 2 Baseline
|
1.20 units on a scale
Standard Deviation 1.83
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 2
Change at Week 64 from Period 1 Baseline
|
-3.49 units on a scale
Standard Deviation 2.47
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 2
Change at Week 64 from Period 2 Baseline
|
1.49 units on a scale
Standard Deviation 2.66
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Here, "number analyzed" signifies participants evaluable at specific time points.
BASDAI consisted of 6 questions related to disease activity. Each of the first 5 questions was scored by the participant on a 100 mm scale ranging from 0 (none) to 100 (very severe), where higher scores indicated more severe disease activity. The sixth question, related to duration of morning stiffness measured on a scale for 0 (0 hours) to 100 (2 hours), where higher scores indicated larger duration of morning stiffness. The BASDAI score was obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 \[severity of morning stiffness\] and 6 \[duration of morning stiffness\]) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The BASDAI total score ranged from 0 to 10, where higher scores indicated more severe disease activity. The reported values were converted to cm for analysis.
Outcome measures
| Measure |
Etanercept
n=87 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 3
Change at Week 64 from Period 2 Baseline
|
4.63 units on a scale
Standard Deviation 2.14
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 3
Change at Week 76 from Period 1 Baseline
|
-4.87 units on a scale
Standard Deviation 2.21
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 3
Change at Week 76 from Period 2 Baseline
|
0.91 units on a scale
Standard Deviation 1.51
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 3
Change at Week 76 from Period 3 Baseline
|
-4.03 units on a scale
Standard Deviation 2.38
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 3
Period 3 Baseline
|
5.53 units on a scale
Standard Deviation 2.24
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 3
Change at Week 64 from Period 1 Baseline
|
-0.92 units on a scale
Standard Deviation 2.82
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 3
Change at Week 64 from Period 3 Baseline
|
0.37 units on a scale
Standard Deviation 1.23
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 3
Change at Week 68 from Period 1 Baseline
|
-4.04 units on a scale
Standard Deviation 2.10
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 3
Change at Week 68 from Period 2 Baseline
|
1.66 units on a scale
Standard Deviation 1.87
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 3
Change at Week 68 from Period 3 Baseline
|
-3.26 units on a scale
Standard Deviation 2.15
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 3
Change at Week 72 from Period 1 Baseline
|
-4.47 units on a scale
Standard Deviation 2.11
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 3
Change at Week 72 from Period 2 Baseline
|
1.22 units on a scale
Standard Deviation 1.73
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 3
Change at Week 72 from Period 3 Baseline
|
-3.65 units on a scale
Standard Deviation 2.33
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
BASDAI consisted of 6 questions related to disease activity. Each of the first 5 questions was scored by the participant on a 100 mm scale ranging from 0 (none) to 100 (very severe), where higher scores indicated more severe disease activity. The sixth question, related to duration of morning stiffness measured on a scale for 0 (0 hours) to 100 (2 hours), where higher scores indicated larger duration of morning stiffness. The BASDAI score was obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 \[severity of morning stiffness\] and 6 \[duration of morning stiffness\]) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The BASDAI total score ranged from 0 to 10, where higher scores indicated more severe disease activity. The reported values were converted to cm for analysis.
Outcome measures
| Measure |
Etanercept
n=209 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Last Observation Carried Forward (LOCF): Period 1
Baseline
|
6.41 units on a scale
Standard Deviation 1.80
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Last Observation Carried Forward (LOCF): Period 1
Change at week 4
|
-2.39 units on a scale
Standard Deviation 1.93
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Last Observation Carried Forward (LOCF): Period 1
Change at week 8
|
-3.07 units on a scale
Standard Deviation 2.16
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Last Observation Carried Forward (LOCF): Period 1
Change at week 12
|
-3.34 units on a scale
Standard Deviation 2.36
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Last Observation Carried Forward (LOCF): Period 1
Change at week 16
|
-3.74 units on a scale
Standard Deviation 2.36
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Last Observation Carried Forward (LOCF): Period 1
Change at week 24
|
-4.41 units on a scale
Standard Deviation 2.49
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
BASDAI consisted of 6 questions related to disease activity. Each of the first 5 questions was scored by the participant on a 100 mm scale ranging from 0 (none) to 100 (very severe), where higher scores indicated more severe disease activity. The sixth question, related to duration of morning stiffness measured on a scale for 0 (0 hours) to 100 (2 hours), where higher scores indicated larger duration of morning stiffness. The BASDAI score was obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 \[severity of morning stiffness\] and 6 \[duration of morning stiffness\]) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The BASDAI total score ranged from 0 to 10, where higher scores indicated more severe disease activity. The reported values were converted to cm for analysis.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score:Last Observation Carried Forward (LOCF): Period 2
Change at Week 56 from Period 1 Baseline
|
-2.42 units on a scale
Standard Deviation 2.75
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score:Last Observation Carried Forward (LOCF): Period 2
Period 2 Baseline
|
0.63 units on a scale
Standard Deviation 0.66
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score:Last Observation Carried Forward (LOCF): Period 2
Change at Week 28 from Period 1 Baseline
|
-4.10 units on a scale
Standard Deviation 2.61
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score:Last Observation Carried Forward (LOCF): Period 2
Change at Week 28 from Period 2 Baseline
|
1.38 units on a scale
Standard Deviation 2.27
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score:Last Observation Carried Forward (LOCF): Period 2
Change at Week 32 from Period 1 Baseline
|
-3.49 units on a scale
Standard Deviation 2.75
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score:Last Observation Carried Forward (LOCF): Period 2
Change at Week 32 from Period 2 Baseline
|
1.99 units on a scale
Standard Deviation 2.57
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score:Last Observation Carried Forward (LOCF): Period 2
Change at Week 40 from Period 1 Baseline
|
-2.96 units on a scale
Standard Deviation 2.80
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score:Last Observation Carried Forward (LOCF): Period 2
Change at Week 40 from Period 2 Baseline
|
2.52 units on a scale
Standard Deviation 2.76
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score:Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 1 Baseline
|
-2.60 units on a scale
Standard Deviation 2.76
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score:Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 2 Baseline
|
2.88 units on a scale
Standard Deviation 2.77
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score:Last Observation Carried Forward (LOCF): Period 2
Change at Week 56 from Period 2 Baseline
|
3.06 units on a scale
Standard Deviation 2.76
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score:Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 1 Baseline
|
-2.15 units on a scale
Standard Deviation 2.71
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score:Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 2 Baseline
|
3.33 units on a scale
Standard Deviation 2.82
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
BASDAI consisted of 6 questions related to disease activity. Each of the first 5 questions was scored by the participant on a 100 mm scale ranging from 0 (none) to 100 (very severe), where higher scores indicated more severe disease activity. The sixth question, related to duration of morning stiffness measured on a scale for 0 (0 hours) to 100 (2 hours), where higher scores indicated larger duration of morning stiffness. The BASDAI score was obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 \[severity of morning stiffness\] and 6 \[duration of morning stiffness\]) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The BASDAI total score ranged from 0 to 10, where higher scores indicated more severe disease activity. The reported values were converted to cm for analysis.
Outcome measures
| Measure |
Etanercept
n=87 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Last Observation Carried Forward (LOCF): Period 3
Change at Week 68 from Period 2 Baseline
|
1.68 units on a scale
Standard Deviation 1.86
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 1 Baseline
|
-4.78 units on a scale
Standard Deviation 2.26
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Last Observation Carried Forward (LOCF): Period 3
Period 3 Baseline
|
5.53 units on a scale
Standard Deviation 2.24
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 1 Baseline
|
-0.92 units on a scale
Standard Deviation 2.82
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 2 Baseline
|
4.63 units on a scale
Standard Deviation 2.14
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 3 Baseline
|
0.37 units on a scale
Standard Deviation 1.23
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Last Observation Carried Forward (LOCF): Period 3
Change at Week 68 from Period 1 Baseline
|
-4.01 units on a scale
Standard Deviation 2.11
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Last Observation Carried Forward (LOCF): Period 3
Change at Week 68 from Period 3 Baseline
|
-3.20 units on a scale
Standard Deviation 2.19
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Last Observation Carried Forward (LOCF): Period 3
Change at Week 72 from Period 1 Baseline
|
-4.47 units on a scale
Standard Deviation 2.11
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Last Observation Carried Forward (LOCF): Period 3
Change at Week 72 from Period 2 Baseline
|
1.22 units on a scale
Standard Deviation 1.73
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Last Observation Carried Forward (LOCF): Period 3
Change at Week 72 from Period 3 Baseline
|
-3.65 units on a scale
Standard Deviation 2.33
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 2 Baseline
|
0.91 units on a scale
Standard Deviation 1.51
|
—
|
—
|
|
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 3 Baseline
|
-3.96 units on a scale
Standard Deviation 2.42
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Here, "Overall Number of Participants Analyzed" signifies participants evaluable at this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
50% improvement from baseline in BASDAI: percentage of participants who achieved 50% decrease from baseline in their BASDAI total score. BASDAI consisted: 6 questions (Q) related to disease activity. Each of first 5 questions was scored by participant on 100 mm scale, range 0=none to 100=very severe, higher scores = more severe disease activity. Sixth question: duration of morning stiffness, was on scale for 0=0 hours to 100=2 hours, higher scores = larger duration of morning stiffness. BASDAI score was obtained by computing mean score for 2 questions related to morning stiffness (Q5 \[severity of morning stiffness\], Q6 \[duration of morning stiffness\]) and adding that value to sum of the scores for first 4Q and then dividing total by 5. BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. BASDAI total score ranged from 0 to 10, higher scores = more severe disease activity. Reported values were converted to cm for analysis. Improvement was relative to baseline (Day 1).
Outcome measures
| Measure |
Etanercept
n=208 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Observed Cases (OC): Period 1
Week 4
|
33.7 percentage of participants
Interval 27.49 to 40.27
|
—
|
—
|
|
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Observed Cases (OC): Period 1
Week 8
|
50.7 percentage of participants
Interval 43.87 to 57.61
|
—
|
—
|
|
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Observed Cases (OC): Period 1
Week 12
|
57.1 percentage of participants
Interval 50.12 to 63.82
|
—
|
—
|
|
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Observed Cases (OC): Period 1
Week 16
|
66.7 percentage of participants
Interval 59.79 to 73.05
|
—
|
—
|
|
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Observed Cases (OC): Period 1
Week 24
|
78.9 percentage of participants
Interval 72.74 to 84.28
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 2 baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Here, "number analyzed" signifies participants evaluable at specific time points.
50% improvement from baseline in BASDAI: percentage of participants who achieved 50% decrease from baseline in their BASDAI total score. BASDAI consisted: 6 questions (Q) related to disease activity. Each of first 5 questions was scored by participant on 100 mm scale, range 0=none to 100=very severe, higher scores = more severe disease activity. Sixth question: duration of morning stiffness, was on scale for 0=0 hours to 100=2 hours, higher scores = larger duration of morning stiffness. BASDAI score obtained by computing mean score for 2 questions related to morning stiffness (Q5 \[severity of morning stiffness\], Q6 \[duration of morning stiffness\]) and adding that value to sum of scores for first 4Q and then dividing total by 5. BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. BASDAI total score ranged from 0 to 10, higher scores = more severe disease activity. Reported values were converted to cm for analysis. The improvement was relative to period 2 baseline(last visit before treatment withdrawal).
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Observed Cases (OC): Period 2
Week 28
|
77.7 percentage of participants
Interval 69.33 to 84.62
|
—
|
—
|
|
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Observed Cases (OC): Period 2
Week 32
|
77.7 percentage of participants
Interval 68.48 to 85.16
|
—
|
—
|
|
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Observed Cases (OC): Period 2
Week 40
|
73.9 percentage of participants
Interval 62.72 to 83.14
|
—
|
—
|
|
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Observed Cases (OC): Period 2
Week 48
|
77.4 percentage of participants
Interval 64.84 to 86.98
|
—
|
—
|
|
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Observed Cases (OC): Period 2
Week 56
|
83.3 percentage of participants
Interval 70.04 to 92.22
|
—
|
—
|
|
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Observed Cases (OC): Period 2
Week 64
|
76.5 percentage of participants
Interval 60.45 to 88.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 3 baseline (last visit before retreatment), Week 64, 68, 72, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Here, "number analyzed" signifies participants evaluable at specific time points.
50% improvement from baseline in BASDAI: percentage of participants who achieved 50% decrease from baseline in their BASDAI total score. BASDAI consisted: 6 questions (Q) related to disease activity. Each of first 5 questions was scored by participant on 100 mm scale, range 0=none to 100=very severe, higher scores = more severe disease activity. Sixth question: duration of morning stiffness, was on scale for 0=0 hours to 100=2 hours, higher scores = larger duration of morning stiffness. BASDAI score was obtained by computing mean score for 2 questions related to morning stiffness (Q5 \[severity of morning stiffness\], Q6 \[duration of morning stiffness\]) and adding that value to sum of the scores for first 4Q and then dividing total by 5. BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. BASDAI total score ranged from 0 to 10, higher scores = more severe disease activity. Reported values were converted to cm for analysis. The improvement was relative to period 3 baseline (last visit before retreatment).
Outcome measures
| Measure |
Etanercept
n=87 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Observed Cases (OC): Period 3
Week 64
|
20.0 percentage of participants
Interval 5.98 to 44.36
|
—
|
—
|
|
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Observed Cases (OC): Period 3
Week 68
|
72.9 percentage of participants
Interval 62.84 to 81.51
|
—
|
—
|
|
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Observed Cases (OC): Period 3
Week 72
|
78.2 percentage of participants
Interval 68.65 to 85.83
|
—
|
—
|
|
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Observed Cases (OC): Period 3
Week 76
|
84.7 percentage of participants
Interval 75.95 to 91.15
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Missing data was imputed using mixed LOCF. Here, "Overall Number of Participants Analyzed" included participants who were evaluable for this outcome measure.
50% improvement from baseline in BASDAI: percentage of participants who achieved 50% decrease from baseline in their BASDAI total score. BASDAI consisted: 6 questions (Q) related to disease activity. Each of first 5 questions was scored by participant on 100 mm scale, range 0=none to 100=very severe, higher scores = more severe disease activity. Sixth question: duration of morning stiffness, was on scale for 0=0 hours to 100=2 hours, higher scores = larger duration of morning stiffness. BASDAI score was obtained by computing mean score for 2 questions related to morning stiffness (Q5 \[severity of morning stiffness\], Q6 \[duration of morning stiffness\]) and adding that value to sum of the scores for first 4Q and then dividing total by 5. BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. BASDAI total score ranged from 0 to 10, higher scores = more severe disease activity. Reported values were converted to cm for analysis. Improvement was relative to baseline (Day 1).
Outcome measures
| Measure |
Etanercept
n=208 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) :Last Observation Carried Forward (LOCF): Period 1
Week 4
|
33.7 percentage of participants
Interval 27.49 to 40.27
|
—
|
—
|
|
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) :Last Observation Carried Forward (LOCF): Period 1
Week 8
|
50.5 percentage of participants
Interval 43.72 to 57.23
|
—
|
—
|
|
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) :Last Observation Carried Forward (LOCF): Period 1
Week 12
|
55.8 percentage of participants
Interval 48.98 to 62.4
|
—
|
—
|
|
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) :Last Observation Carried Forward (LOCF): Period 1
Week 16
|
63.9 percentage of participants
Interval 57.26 to 70.24
|
—
|
—
|
|
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) :Last Observation Carried Forward (LOCF): Period 1
Week 24
|
75.0 percentage of participants
Interval 68.8 to 80.51
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 2 baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
50% improvement from baseline in BASDAI: percentage of participants who achieved 50% decrease from baseline in their BASDAI total score. BASDAI consisted: 6 questions (Q) related to disease activity. Each of first 5 questions was scored by participant on 100 mm scale, range 0=none to 100=very severe, higher scores = more severe disease activity. Sixth question: duration of morning stiffness, was on scale for 0=0 hours to 100=2 hours, higher scores = larger duration of morning stiffness. BASDAI score obtained by computing mean score for 2 questions related to morning stiffness (Q5 \[severity of morning stiffness\], Q6 \[duration of morning stiffness\]) and adding that value to sum of scores for first 4Q and then dividing total by 5. BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. BASDAI total score ranged from 0 to 10, higher scores = more severe disease activity. Reported values were converted to cm for analysis. The improvement was relative to period 2 baseline(last visit before treatment withdrawal).
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) :Last Observation Carried Forward (LOCF): Period 2
Week 28
|
77.7 percentage of participants
Interval 69.33 to 84.62
|
—
|
—
|
|
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) :Last Observation Carried Forward (LOCF): Period 2
Week 32
|
67.0 percentage of participants
Interval 58.02 to 75.05
|
—
|
—
|
|
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) :Last Observation Carried Forward (LOCF): Period 2
Week 40
|
57.4 percentage of participants
Interval 48.26 to 66.15
|
—
|
—
|
|
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) :Last Observation Carried Forward (LOCF): Period 2
Week 48
|
51.3 percentage of participants
Interval 42.23 to 60.31
|
—
|
—
|
|
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) :Last Observation Carried Forward (LOCF): Period 2
Week 56
|
47.0 percentage of participants
Interval 38.01 to 56.06
|
—
|
—
|
|
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) :Last Observation Carried Forward (LOCF): Period 2
Week 64
|
41.7 percentage of participants
Interval 33.02 to 50.86
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 3 baseline (last visit before retreatment), Week 64, 68, 72, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
50% improvement from baseline in BASDAI: percentage of participants who achieved 50% decrease from baseline in their BASDAI total score. BASDAI consisted: 6 questions (Q) related to disease activity. Each of first 5 questions was scored by participant on 100 mm scale, range 0=none to 100=very severe, higher scores = more severe disease activity. Sixth question: duration of morning stiffness, was on scale for 0=0 hours to 100=2 hours, higher scores = larger duration of morning stiffness. BASDAI score was obtained by computing mean score for 2 questions related to morning stiffness (Q5 \[severity of morning stiffness\], Q6 \[duration of morning stiffness\]) and adding that value to sum of the scores for first 4Q and then dividing total by 5. BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. BASDAI total score ranged from 0 to 10, higher scores = more severe disease activity. Reported values were converted to cm for analysis. The improvement was relative to period 3 baseline (last visit before retreatment).
Outcome measures
| Measure |
Etanercept
n=87 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) :Last Observation Carried Forward (LOCF): Period 3
Week 64
|
20.0 percentage of participants
Interval 5.98 to 44.36
|
—
|
—
|
|
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) :Last Observation Carried Forward (LOCF): Period 3
Week 68
|
72.1 percentage of participants
Interval 62.0 to 80.73
|
—
|
—
|
|
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) :Last Observation Carried Forward (LOCF): Period 3
Week 72
|
78.2 percentage of participants
Interval 68.65 to 85.83
|
—
|
—
|
|
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) :Last Observation Carried Forward (LOCF): Period 3
Week 78
|
82.8 percentage of participants
Interval 73.82 to 89.56
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Here, "number analyzed" signifies participants evaluable at specific time points.
Change from baseline in hsCRP levels were reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation.
Outcome measures
| Measure |
Etanercept
n=209 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 1
Change at week 8
|
-9.20 milligram per liter (mg/L)
Standard Deviation 19.68
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 1
Change at week 12
|
-8.98 milligram per liter (mg/L)
Standard Deviation 19.92
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 1
Change at week 16
|
-9.12 milligram per liter (mg/L)
Standard Deviation 20.23
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 1
Baseline
|
12.73 milligram per liter (mg/L)
Standard Deviation 20.63
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 1
Change at week 4
|
-8.72 milligram per liter (mg/L)
Standard Deviation 19.70
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 1
Change at week 24
|
-9.73 milligram per liter (mg/L)
Standard Deviation 19.39
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Here, "number analyzed" signifies participants evaluable at specific time points.
Change from baseline in hsCRP levels were reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 2
Change at Week 40 from Period 1 Baseline
|
-5.87 mg/L
Standard Deviation 13.89
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 2
Period 2 Baseline
|
1.45 mg/L
Standard Deviation 1.54
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 2
Change at Week 28 from Period 1 Baseline
|
-7.46 mg/L
Standard Deviation 15.23
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 2
Change at Week 28 from Period 2 Baseline
|
2.60 mg/L
Standard Deviation 5.76
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 2
Change at Week 32 from Period 1 Baseline
|
-6.94 mg/L
Standard Deviation 16.83
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 2
Change at Week 32 from Period 2 Baseline
|
4.72 mg/L
Standard Deviation 12.31
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 2
Change at Week 40 from Period 2 Baseline
|
3.04 mg/L
Standard Deviation 6.95
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 2
Change at Week 48 from Period 1 Baseline
|
-5.94 mg/L
Standard Deviation 14.65
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 2
Change at Week 48 from Period 2 Baseline
|
3.29 mg/L
Standard Deviation 6.83
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 2
Change at Week 56 from Period 1 Baseline
|
-6.31 mg/L
Standard Deviation 12.65
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 2
Change at Week 56 from Period 2 Baseline
|
2.29 mg/L
Standard Deviation 4.93
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 2
Change at Week 64 from Period 1 Baseline
|
-6.47 mg/L
Standard Deviation 13.43
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 2
Change at Week 64 from Period 2 Baseline
|
2.38 mg/L
Standard Deviation 5.04
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Here, "number analyzed" signifies participants evaluable at specific time points.
Change from baseline in hsCRP levels were reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation.
Outcome measures
| Measure |
Etanercept
n=87 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 3
Period 3 Baseline
|
7.14 mg/L
Standard Deviation 11.88
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 3
Change at Week 64 from Period 1 Baseline
|
-2.58 mg/L
Standard Deviation 14.89
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 3
Change at Week 64 from Period 2 Baseline
|
9.15 mg/L
Standard Deviation 21.38
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 3
Change at Week 64 from Period 3 Baseline
|
1.61 mg/L
Standard Deviation 4.68
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 3
Change at Week 68 from Period 1 Baseline
|
-8.20 mg/L
Standard Deviation 16.77
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 3
Change at Week 68 from Period 2 Baseline
|
0.54 mg/L
Standard Deviation 3.11
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 3
Change at Week 68 from Period 3 Baseline
|
-4.52 mg/L
Standard Deviation 9.23
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 3
Change at Week 72 from Period 1 Baseline
|
-8.21 mg/L
Standard Deviation 16.69
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 3
Change at Week 72 from Period 2 Baseline
|
0.50 mg/L
Standard Deviation 4.38
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 3
Change at Week 72 from Period 3 Baseline
|
-4.46 mg/L
Standard Deviation 9.34
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 3
Change at Week 76 from Period 1 Baseline
|
-7.40 mg/L
Standard Deviation 15.98
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 3
Change at Week 76 from Period 2 Baseline
|
1.39 mg/L
Standard Deviation 5.65
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 3
Change at Week 76 from Period 3 Baseline
|
-3.49 mg/L
Standard Deviation 8.27
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
Change from baseline in hsCRP levels were reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation.
Outcome measures
| Measure |
Etanercept
n=209 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 1
Baseline
|
12.73 mg/L
Standard Deviation 20.63
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 1
Change at week 4
|
-8.72 mg/L
Standard Deviation 19.70
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 1
Change at week 8
|
-9.14 mg/L
Standard Deviation 19.59
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 1
Change at week 12
|
-8.77 mg/L
Standard Deviation 19.66
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 1
Change at week 16
|
-8.72 mg/L
Standard Deviation 19.76
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 1
Change at week 24
|
-9.28 mg/L
Standard Deviation 18.90
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
Change from baseline in hsCRP levels were reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 2
Period 2 Baseline
|
1.45 mg/L
Standard Deviation 1.54
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 2
Change at Week 28 from Period 1 Baseline
|
-7.46 mg/L
Standard Deviation 15.23
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 2
Change at Week 28 from Period 2 Baseline
|
2.60 mg/L
Standard Deviation 5.76
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 2
Change at Week 32 from Period 1 Baseline
|
-5.86 mg/L
Standard Deviation 15.73
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 2
Change at Week 32 from Period 2 Baseline
|
4.46 mg/L
Standard Deviation 11.24
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 2
Change at Week 40 from Period 1 Baseline
|
-5.56 mg/L
Standard Deviation 13.91
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 2
Change at Week 40 from Period 2 Baseline
|
4.76 mg/L
Standard Deviation 10.88
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 1 Baseline
|
-4.83 mg/L
Standard Deviation 14.26
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 2 Baseline
|
5.49 mg/L
Standard Deviation 11.51
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 2
Change at Week 56 from Period 1 Baseline
|
-5.05 mg/L
Standard Deviation 14.01
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 2
Change at Week 56 from Period 2 Baseline
|
5.27 mg/L
Standard Deviation 11.13
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 1 Baseline
|
-4.90 mg/L
Standard Deviation 13.88
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 2 Baseline
|
5.42 mg/L
Standard Deviation 11.28
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
Change from baseline in hsCRP levels were reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation.
Outcome measures
| Measure |
Etanercept
n=87 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 3
Change at Week 68 from Period 1 Baseline
|
-7.98 mg/L
Standard Deviation 16.80
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 3
Period 3 Baseline
|
7.14 mg/L
Standard Deviation 11.88
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 1 Baseline
|
-2.58 mg/L
Standard Deviation 14.89
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 2 Baseline
|
9.15 mg/L
Standard Deviation 21.38
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 3 Baseline
|
1.61 mg/L
Standard Deviation 4.68
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 3
Change at Week 68 from Period 2 Baseline
|
1.53 mg/L
Standard Deviation 9.66
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 3
Change at Week 68 from Period 3 Baseline
|
-4.32 mg/L
Standard Deviation 9.34
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 3
Change at Week 72 from Period 1 Baseline
|
-7.99 mg/L
Standard Deviation 16.71
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 3
Change at Week 72 from Period 2 Baseline
|
1.47 mg/L
Standard Deviation 10.05
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 3
Change at Week 72 from Period 3 Baseline
|
-4.27 mg/L
Standard Deviation 9.45
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 1 Baseline
|
-7.12 mg/L
Standard Deviation 15.93
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 2 Baseline
|
2.34 mg/L
Standard Deviation 10.56
|
—
|
—
|
|
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 3 Baseline
|
-3.38 mg/L
Standard Deviation 8.36
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 12, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Here, "number analyzed" signifies participants evaluable at specific time points.
The EQ-5D questionnaire is a health-related quality of life assessment (HRQOL). The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a VAS with response options. Overall EQ 5D VAS score ranged from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening. In this outcome measure, data for percentage of participants who reached the cut-off value of \> 82 is reported. This threshold was based on participant's demographic characteristics and population norm. The outcome measure was planned to be analyzed at baseline, Week 12 and 24.
Outcome measures
| Measure |
Etanercept
n=209 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 12, 24: Observed Cases (OC): Period 1
Baseline
|
4.3 percentage of participants
Interval 2.15 to 7.71
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 12, 24: Observed Cases (OC): Period 1
Week 12
|
28.5 percentage of participants
Interval 22.68 to 34.92
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 12, 24: Observed Cases (OC): Period 1
Week 24
|
50.3 percentage of participants
Interval 43.21 to 57.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 32, 48, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Here, "number analyzed" signifies participants evaluable at specific time points.
The EQ-5D questionnaire is a HRQOL. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a VAS with response options. Overall EQ 5D VAS score ranged from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening. In this outcome measure, data for percentage of participants who reached the cut-off value of \> 82 is reported. This threshold was based on participant's demographic characteristics and population norm.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 32, 48, 64: Observed Cases (OC): Period 2
Week 32
|
43.0 percentage of participants
Interval 33.9 to 52.45
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 32, 48, 64: Observed Cases (OC): Period 2
Week 48
|
37.9 percentage of participants
Interval 26.9 to 49.9
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 32, 48, 64: Observed Cases (OC): Period 2
Week 64
|
46.3 percentage of participants
Interval 31.76 to 61.42
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 64, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
The EQ-5D questionnaire is a HRQOL. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a VAS with response options. Overall EQ 5D VAS score ranged from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening. In this outcome measure, data for percentage of participants who reached the cut-off value of \> 82 is reported. This threshold was based on participant's demographic characteristics and population norm.
Outcome measures
| Measure |
Etanercept
n=86 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 64, 76: Observed Cases (OC): Period 3
Week 64
|
6.7 percentage of participants
Interval 0.73 to 27.18
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 64, 76: Observed Cases (OC): Period 3
Week 76
|
50.0 percentage of participants
Interval 39.58 to 60.42
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 12, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
The EQ-5D questionnaire is a HRQOL. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a VAS with response options. Overall EQ 5D VAS score ranged from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening. In this outcome measure, data for percentage of participants who reached the cut-off value of \> 82 is reported. This threshold was based on participant's demographic characteristics and population norm. This outcome measure was planned to be analyzed at baseline, Week 12 and 24.
Outcome measures
| Measure |
Etanercept
n=209 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Baseline
|
4.3 percentage of participants
Interval 2.15 to 7.71
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Week 12
|
28.5 percentage of participants
Interval 22.68 to 34.92
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Week 24
|
47.8 percentage of participants
Interval 41.09 to 54.62
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 32, 48, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
The EQ-5D questionnaire is a HRQOL. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a VAS with response options. Overall EQ 5D VAS score ranged from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening. In this outcome measure, data for percentage of participants who reached the cut-off value of \> 82 is reported. This threshold was based on participant's demographic characteristics and population norm.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Week 32
|
43.0 percentage of participants
Interval 33.9 to 52.45
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Week 48
|
32.4 percentage of participants
Interval 24.14 to 41.61
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Week 64
|
28.7 percentage of participants
Interval 20.82 to 37.71
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 64, 76Population: FAS Period 3: all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Missing data was imputed using mixed LOCF. Overall Number of Participants Analyzed" = participants who were evaluable for this outcome measure and "number analyzed" = participants evaluable at specific time points.
The EQ-5D questionnaire is a HRQOL. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a VAS with response options. Overall EQ 5D VAS score ranged from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening. In this outcome measure, data for percentage of participants who reached the cut-off value of \> 82 is reported. This threshold was based on participant's demographic characteristics and population norm.
Outcome measures
| Measure |
Etanercept
n=86 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Week 64
|
6.7 percentage of participants
Interval 0.73 to 27.18
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Week 76
|
50.0 percentage of participants
Interval 39.58 to 60.42
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Here, "Overall Number of Participants Analyzed" signifies participants evaluable at this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''. This outcome measure was planned to be analyzed at baseline, Week 12 and 24.
Outcome measures
| Measure |
Etanercept
n=207 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 12, 24: Observed Cases (OC): Period 1
Week 12
|
70.0 percentage of participants
Interval 63.56 to 75.98
|
—
|
—
|
|
Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 12, 24: Observed Cases (OC): Period 1
Week 24
|
79.1 percentage of participants
Interval 72.88 to 84.37
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 32, 48, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Here, "number analyzed" signifies participants evaluable at specific time points.
The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 32, 48, 64: Observed Cases (OC): Period 2
Week 32
|
72.0 percentage of participants
Interval 62.95 to 79.81
|
—
|
—
|
|
Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 32, 48, 64: Observed Cases (OC): Period 2
Week 48
|
68.2 percentage of participants
Interval 56.35 to 78.46
|
—
|
—
|
|
Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 32, 48, 64: Observed Cases (OC): Period 2
Week 64
|
75.6 percentage of participants
Interval 61.03 to 86.71
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 64, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.
Outcome measures
| Measure |
Etanercept
n=86 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 64, 76: Observed Cases (OC): Period 3
Week 64
|
53.3 percentage of participants
Interval 29.39 to 76.12
|
—
|
—
|
|
Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 64, 76: Observed Cases (OC): Period 3
Week 76
|
82.6 percentage of participants
Interval 73.53 to 89.44
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Missing data was imputed using mixed LOCF. Here, "Overall Number of Participants Analyzed" included participants who were evaluable for this outcome measure.
The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''. This outcome measure was planned to be analyzed at baseline, Week 12 and 24.
Outcome measures
| Measure |
Etanercept
n=207 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Week 12
|
70.0 percentage of participants
Interval 63.56 to 75.98
|
—
|
—
|
|
Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Week 24
|
76.8 percentage of participants
Interval 70.72 to 82.16
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 32, 48, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Week 32
|
72.0 percentage of participants
Interval 62.95 to 79.81
|
—
|
—
|
|
Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Week 48
|
62.0 percentage of participants
Interval 52.66 to 70.77
|
—
|
—
|
|
Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Week 64
|
61.1 percentage of participants
Interval 51.72 to 69.91
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 64, 76Population: FAS Period 3: all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Missing data was imputed using mixed LOCF. Overall Number of Participants Analyzed" = participants who were evaluable for this outcome measure and "number analyzed" = participants evaluable at specific time points.
The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.
Outcome measures
| Measure |
Etanercept
n=86 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Week 64
|
53.3 percentage of participants
Interval 29.39 to 76.12
|
—
|
—
|
|
Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Week 76
|
82.6 percentage of participants
Interval 73.53 to 89.44
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 12, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Here, "number analyzed" signifies participants evaluable at specific time points.
The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''. This outcome measure was planned to be analyzed at baseline, Week 12 and 24.
Outcome measures
| Measure |
Etanercept
n=209 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Observed Cases (OC): Period 1
Baseline: mobility
|
32.5 percentage of participants
Interval 26.46 to 39.09
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Observed Cases (OC): Period 1
Baseline: self-care
|
64.6 percentage of participants
Interval 57.94 to 70.84
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Observed Cases (OC): Period 1
Baseline: usual activity
|
20.6 percentage of participants
Interval 15.52 to 26.44
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Observed Cases (OC): Period 1
Baseline: pain/discomfort
|
1.9 percentage of participants
Interval 0.65 to 4.49
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Observed Cases (OC): Period 1
Baseline: anxiety/depression
|
37.3 percentage of participants
Interval 30.97 to 44.02
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Observed Cases (OC): Period 1
Week 12: mobility
|
65.2 percentage of participants
Interval 58.55 to 71.46
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Observed Cases (OC): Period 1
Week 12: self-care
|
86.5 percentage of participants
Interval 81.32 to 90.62
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Observed Cases (OC): Period 1
Week 12: usual activity
|
48.3 percentage of participants
Interval 41.56 to 55.1
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Observed Cases (OC): Period 1
Week 12: pain/discomfort
|
25.6 percentage of participants
Interval 20.03 to 31.86
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Observed Cases (OC): Period 1
Week 12: anxiety/depression
|
64.7 percentage of participants
Interval 58.06 to 71.0
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Observed Cases (OC): Period 1
Week 24: mobility
|
80.6 percentage of participants
Interval 74.59 to 85.75
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Observed Cases (OC): Period 1
Week 24: self-care
|
93.2 percentage of participants
Interval 88.96 to 96.13
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Observed Cases (OC): Period 1
Week 24: usual activity
|
64.4 percentage of participants
Interval 57.43 to 70.93
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Observed Cases (OC): Period 1
Week 24: pain/discomfort
|
44.0 percentage of participants
Interval 37.07 to 51.06
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Observed Cases (OC): Period 1
Week 24: anxiety/depression
|
78.0 percentage of participants
Interval 71.74 to 83.44
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 32, 48, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Here, "number analyzed" signifies participants evaluable at specific time points.
The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Observed Cases (OC): Period 2
Week 48: pain/discomfort
|
31.8 percentage of participants
Interval 21.54 to 43.65
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Observed Cases (OC): Period 2
Week 32: mobility
|
66.4 percentage of participants
Interval 57.06 to 74.78
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Observed Cases (OC): Period 2
Week 32: self-care
|
83.2 percentage of participants
Interval 75.25 to 89.34
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Observed Cases (OC): Period 2
Week 32: usual activity
|
55.1 percentage of participants
Interval 45.68 to 64.32
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Observed Cases (OC): Period 2
Week 32: pain/discomfort
|
28.0 percentage of participants
Interval 20.19 to 37.05
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Observed Cases (OC): Period 2
Week 32: anxiety/depression
|
70.1 percentage of participants
Interval 60.97 to 78.15
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Observed Cases (OC): Period 2
Week 48: mobility
|
71.2 percentage of participants
Interval 59.56 to 81.05
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Observed Cases (OC): Period 2
Week 48: self-care
|
87.9 percentage of participants
Interval 78.43 to 94.1
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Observed Cases (OC): Period 2
Week 48: usual activity
|
66.7 percentage of participants
Interval 54.77 to 77.14
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Observed Cases (OC): Period 2
Week 48: anxiety/depression
|
69.7 percentage of participants
Interval 57.95 to 79.76
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Observed Cases (OC): Period 2
Week 64: mobility
|
68.3 percentage of participants
Interval 53.18 to 80.92
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Observed Cases (OC): Period 2
Week 64: self-care
|
85.4 percentage of participants
Interval 72.3 to 93.65
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Observed Cases (OC): Period 2
Week 64: usual activity
|
63.4 percentage of participants
Interval 48.17 to 76.84
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Observed Cases (OC): Period 2
Week 64: pain/discomfort
|
34.1 percentage of participants
Interval 21.1 to 49.35
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Observed Cases (OC): Period 2
Week 64: anxiety/depression
|
73.2 percentage of participants
Interval 58.37 to 84.83
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 64, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.
Outcome measures
| Measure |
Etanercept
n=86 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 64, 76: Observed Cases (OC): Period 3
Week 64: mobility
|
26.7 percentage of participants
Interval 9.74 to 51.66
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 64, 76: Observed Cases (OC): Period 3
Week 64: self-care
|
73.3 percentage of participants
Interval 48.34 to 90.26
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 64, 76: Observed Cases (OC): Period 3
Week 64: usual activity
|
26.7 percentage of participants
Interval 9.74 to 51.66
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 64, 76: Observed Cases (OC): Period 3
Week 64: pain/discomfort
|
6.7 percentage of participants
Interval 0.73 to 27.18
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 64, 76: Observed Cases (OC): Period 3
Week 64: anxiety/depression
|
46.7 percentage of participants
Interval 23.88 to 70.61
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 64, 76: Observed Cases (OC): Period 3
Week 76: mobility
|
73.3 percentage of participants
Interval 63.24 to 81.73
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 64, 76: Observed Cases (OC): Period 3
Week 76: self-care
|
93.0 percentage of participants
Interval 86.19 to 97.04
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 64, 76: Observed Cases (OC): Period 3
Week 76: usual activity
|
61.6 percentage of participants
Interval 51.1 to 71.38
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 64, 76: Observed Cases (OC): Period 3
Week 76: pain/discomfort
|
40.7 percentage of participants
Interval 30.76 to 51.25
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 64, 76: Observed Cases (OC): Period 3
Week 76: anxiety/depression
|
75.6 percentage of participants
Interval 65.76 to 83.71
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 12, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''. This outcome measure was planned to be analyzed at baseline, Week 12 and 24.
Outcome measures
| Measure |
Etanercept
n=209 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Week 12: usual activity
|
48.3 percentage of participants
Interval 41.56 to 55.1
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Week 12: pain/discomfort
|
25.6 percentage of participants
Interval 20.03 to 31.86
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Week 24: pain/discomfort
|
41.1 percentage of participants
Interval 34.52 to 47.85
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Baseline: mobility
|
32.5 percentage of participants
Interval 26.46 to 39.09
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Baseline: self-care
|
64.6 percentage of participants
Interval 57.94 to 70.84
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Baseline: usual activity
|
20.6 percentage of participants
Interval 15.52 to 26.44
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Baseline: pain/discomfort
|
1.9 percentage of participants
Interval 0.65 to 4.49
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Baseline: anxiety/depression
|
37.3 percentage of participants
Interval 30.97 to 44.02
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Week 12: mobility
|
65.2 percentage of participants
Interval 58.55 to 71.46
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Week 12: self-care
|
86.5 percentage of participants
Interval 81.32 to 90.62
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Week 12: anxiety/depression
|
64.7 percentage of participants
Interval 58.06 to 71.0
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Week 24: mobility
|
77.3 percentage of participants
Interval 71.23 to 82.6
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Week 24: self-care
|
91.8 percentage of participants
Interval 87.46 to 94.95
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Week 24: usual activity
|
61.4 percentage of participants
Interval 54.6 to 67.79
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Week 24: anxiety/depression
|
75.8 percentage of participants
Interval 69.68 to 81.29
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 32, 48, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Week 32: mobility
|
66.4 percentage of participants
Interval 57.06 to 74.78
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Week 32: self-care
|
83.2 percentage of participants
Interval 75.25 to 89.34
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Week 32: usual activity
|
55.1 percentage of participants
Interval 45.68 to 64.32
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Week 32: pain/discomfort
|
28.0 percentage of participants
Interval 20.19 to 37.05
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Week 32: anxiety/depression
|
70.1 percentage of participants
Interval 60.97 to 78.15
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Week 48: mobility
|
57.4 percentage of participants
Interval 47.99 to 66.44
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Week 48: self-care
|
77.8 percentage of participants
Interval 69.27 to 84.82
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Week 48: usual activity
|
51.9 percentage of participants
Interval 42.48 to 61.12
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Week 48: pain/discomfort
|
22.2 percentage of participants
Interval 15.18 to 30.73
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Week 48: anxiety/depression
|
66.7 percentage of participants
Interval 57.43 to 75.03
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Week 64: mobility
|
51.9 percentage of participants
Interval 42.48 to 61.12
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Week 64: self-care
|
72.2 percentage of participants
Interval 63.27 to 80.0
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Week 64: usual activity
|
44.4 percentage of participants
Interval 35.32 to 53.86
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Week 64: pain/discomfort
|
16.7 percentage of participants
Interval 10.56 to 24.53
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Week 64: anxiety/depression
|
65.7 percentage of participants
Interval 56.47 to 74.18
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 64, 76Population: FAS Period 3: all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Missing data was imputed using mixed LOCF. Overall Number of Participants Analyzed" = participants who were evaluable for this outcome measure and "number analyzed" = participants evaluable at specific time points.
The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.
Outcome measures
| Measure |
Etanercept
n=86 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Week 64: mobility
|
26.7 percentage of participants
Interval 9.74 to 51.66
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Week 64: self-care
|
73.3 percentage of participants
Interval 48.34 to 90.26
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Week 64: usual activity
|
26.7 percentage of participants
Interval 9.74 to 51.66
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Week 64: pain/discomfort
|
6.7 percentage of participants
Interval 0.73 to 27.18
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Week 64: anxiety/depression
|
46.7 percentage of participants
Interval 23.88 to 70.61
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Week 76: mobility
|
73.3 percentage of participants
Interval 63.24 to 81.73
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Week 76: self-care
|
93.0 percentage of participants
Interval 86.19 to 97.04
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Week 76: usual activity
|
61.6 percentage of participants
Interval 51.1 to 71.38
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Week 76: pain/discomfort
|
40.7 percentage of participants
Interval 30.76 to 51.25
|
—
|
—
|
|
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Week 76: anxiety/depression
|
75.6 percentage of participants
Interval 65.76 to 83.71
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 12, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Here, "number analyzed" signifies participants evaluable at specific time points.
The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.
Outcome measures
| Measure |
Etanercept
n=209 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 12, 24: Observed Cases (OC): Period 1
Baseline
|
0.42 units on a scale
Standard Deviation 0.35
|
—
|
—
|
|
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 12, 24: Observed Cases (OC): Period 1
Change at week 12
|
0.30 units on a scale
Standard Deviation 0.35
|
—
|
—
|
|
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 12, 24: Observed Cases (OC): Period 1
Change at week 24
|
0.38 units on a scale
Standard Deviation 0.37
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Here, "number analyzed" signifies participants evaluable at specific time points.
The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 32, 48, 64: Observed Cases (OC): Period 2
Period 2 Baseline
|
0.89 units on a scale
Standard Deviation 0.14
|
—
|
—
|
|
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 32 from Period 1 Baseline
|
0.27 units on a scale
Standard Deviation 0.35
|
—
|
—
|
|
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 32 from Period 2 Baseline
|
-0.15 units on a scale
Standard Deviation 0.24
|
—
|
—
|
|
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 48 from Period 1 Baseline
|
0.26 units on a scale
Standard Deviation 0.32
|
—
|
—
|
|
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 48 from Period 2 Baseline
|
-0.13 units on a scale
Standard Deviation 0.25
|
—
|
—
|
|
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 64 from Period 1 Baseline
|
0.25 units on a scale
Standard Deviation 0.28
|
—
|
—
|
|
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 64 from Period 2 Baseline
|
-0.12 units on a scale
Standard Deviation 0.22
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.
Outcome measures
| Measure |
Etanercept
n=86 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 64, 76: Observed Cases (OC): Period 3
Period 3 Baseline
|
0.55 units on a scale
Standard Deviation 0.27
|
—
|
—
|
|
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 64 from Period 1 Baseline
|
0.17 units on a scale
Standard Deviation 0.51
|
—
|
—
|
|
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 64 from Period 2 Baseline
|
-0.29 units on a scale
Standard Deviation 0.27
|
—
|
—
|
|
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 64 from Period 3 Baseline
|
0.01 units on a scale
Standard Deviation 0.12
|
—
|
—
|
|
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 76 from Period 1 Baseline
|
0.43 units on a scale
Standard Deviation 0.37
|
—
|
—
|
|
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 76 from Period 2 Baseline
|
-0.06 units on a scale
Standard Deviation 0.15
|
—
|
—
|
|
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 76 from Period 3 Baseline
|
0.27 units on a scale
Standard Deviation 0.31
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 12, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.
Outcome measures
| Measure |
Etanercept
n=209 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Baseline
|
0.42 units on a scale
Standard Deviation 0.35
|
—
|
—
|
|
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Change at week 12
|
0.30 units on a scale
Standard Deviation 0.35
|
—
|
—
|
|
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Change at week 24
|
0.37 units on a scale
Standard Deviation 0.37
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 1 Baseline
|
0.24 units on a scale
Standard Deviation 0.33
|
—
|
—
|
|
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 2 Baseline
|
-0.18 units on a scale
Standard Deviation 0.27
|
—
|
—
|
|
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 1 Baseline
|
0.21 units on a scale
Standard Deviation 0.30
|
—
|
—
|
|
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Period 2 Baseline
|
0.89 units on a scale
Standard Deviation 0.14
|
—
|
—
|
|
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 32 from Period 1 Baseline
|
0.27 units on a scale
Standard Deviation 0.35
|
—
|
—
|
|
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 32 from Period 2 Baseline
|
-0.15 units on a scale
Standard Deviation 0.24
|
—
|
—
|
|
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 2 Baseline
|
-0.21 units on a scale
Standard Deviation 0.27
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76Population: FAS Period 3: all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Missing data was imputed using mixed LOCF. Overall Number of Participants Analyzed" = participants who were evaluable for this outcome measure and "number analyzed" = participants evaluable at specific time points.
The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.
Outcome measures
| Measure |
Etanercept
n=86 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Period 3 Baseline
|
0.55 units on a scale
Standard Deviation 0.27
|
—
|
—
|
|
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 1 Baseline
|
0.17 units on a scale
Standard Deviation 0.51
|
—
|
—
|
|
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 2 Baseline
|
-0.29 units on a scale
Standard Deviation 0.27
|
—
|
—
|
|
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 3 Baseline
|
0.01 units on a scale
Standard Deviation 0.12
|
—
|
—
|
|
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 1 Baseline
|
0.43 units on a scale
Standard Deviation 0.37
|
—
|
—
|
|
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 2 Baseline
|
-0.06 units on a scale
Standard Deviation 0.15
|
—
|
—
|
|
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 3 Baseline
|
0.27 units on a scale
Standard Deviation 0.31
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 12, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores (physical component scores \[PCS\]; mental component scores \[MCS\]). Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value).
Outcome measures
| Measure |
Etanercept
n=193 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 12, 24: Observed Cases (OC): Period 1
Baseline
|
33.29 units on a scale
Standard Deviation 7.13
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 12, 24: Observed Cases (OC): Period 1
Change at week 12
|
8.84 units on a scale
Standard Deviation 8.54
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 12, 24: Observed Cases (OC): Period 1
Change at week 24
|
12.90 units on a scale
Standard Deviation 9.30
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value).
Outcome measures
| Measure |
Etanercept
n=114 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 32, 48, 64: Observed Cases (OC): Period 2
Period 2 Baseline
|
50.03 units on a scale
Standard Deviation 6.96
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 32 from Period 1 Baseline
|
9.62 units on a scale
Standard Deviation 10.50
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 32 from Period 2 Baseline
|
-5.97 units on a scale
Standard Deviation 9.07
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 48 from Period 1 Baseline
|
8.02 units on a scale
Standard Deviation 9.53
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 48 from Period 2 Baseline
|
-7.84 units on a scale
Standard Deviation 8.72
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 64 from Period 1 Baseline
|
9.18 units on a scale
Standard Deviation 9.34
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 64 from Period 2 Baseline
|
-7.17 units on a scale
Standard Deviation 9.32
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value).
Outcome measures
| Measure |
Etanercept
n=82 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 64, 76: Observed Cases (OC): Period 3
Period 3 Baseline
|
34.39 units on a scale
Standard Deviation 7.16
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 64 from Period 1 Baseline
|
-0.81 units on a scale
Standard Deviation 9.87
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 64 from Period 2 Baseline
|
-16.06 units on a scale
Standard Deviation 9.61
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 64 from Period 3 Baseline
|
-2.98 units on a scale
Standard Deviation 3.72
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 76 from Period 1 Baseline
|
11.76 units on a scale
Standard Deviation 7.84
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 76 from Period 2 Baseline
|
-3.21 units on a scale
Standard Deviation 5.47
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 76 from Period 3 Baseline
|
11.36 units on a scale
Standard Deviation 8.61
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 12, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Missing data was imputed using mixed LOCF. Overall Number of Participants Analyzed" = participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value).
Outcome measures
| Measure |
Etanercept
n=193 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Baseline
|
33.29 units on a scale
Standard Deviation 7.13
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Change at week 12
|
8.84 units on a scale
Standard Deviation 8.54
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Change at week 24
|
12.14 units on a scale
Standard Deviation 9.37
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Missing data was imputed using mixed LOCF. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value).
Outcome measures
| Measure |
Etanercept
n=114 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 1 Baseline
|
6.52 units on a scale
Standard Deviation 10.40
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 2 Baseline
|
-9.19 units on a scale
Standard Deviation 9.37
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 1 Baseline
|
5.52 units on a scale
Standard Deviation 10.57
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 2 Baseline
|
-10.32 units on a scale
Standard Deviation 9.64
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Period 2 Baseline
|
50.03 units on a scale
Standard Deviation 6.96
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 32 from Period 1 Baseline
|
9.62 units on a scale
Standard Deviation 10.50
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 32 from Period 2 Baseline
|
-5.97 units on a scale
Standard Deviation 9.07
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76Population: FAS Period 3: all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Missing data was imputed using mixed LOCF. Overall Number of Participants Analyzed" = participants who were evaluable for this outcome measure and "number analyzed" = participants evaluable at specific time points.
SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value).
Outcome measures
| Measure |
Etanercept
n=82 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Period 3 Baseline
|
34.39 units on a scale
Standard Deviation 7.16
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 1 Baseline
|
-0.81 units on a scale
Standard Deviation 9.87
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 2 Baseline
|
-16.06 units on a scale
Standard Deviation 9.61
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 3 Baseline
|
-2.98 units on a scale
Standard Deviation 3.72
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 1 Baseline
|
11.76 units on a scale
Standard Deviation 7.84
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 2 Baseline
|
-3.21 units on a scale
Standard Deviation 5.47
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 3 Baseline
|
11.36 units on a scale
Standard Deviation 8.61
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 12, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). The improvement was relative to baseline (Day 1).
Outcome measures
| Measure |
Etanercept
n=197 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 12, 24: Period 1
Week 12
|
73.1 percentage of participants
Interval 66.6 to 78.92
|
—
|
—
|
|
Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 12, 24: Period 1
Week 24
|
79.6 percentage of participants
Interval 73.35 to 84.88
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 2 baseline (last visit before treatment withdrawal), Week 32, 48, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). Improvement was relative to period 2 baseline (last visit before treatment withdrawal).
Outcome measures
| Measure |
Etanercept
n=103 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 32, 48, 64: Period 2
Week 32
|
72.8 percentage of participants
Interval 63.68 to 80.69
|
—
|
—
|
|
Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 32, 48, 64: Period 2
Week 48
|
70.3 percentage of participants
Interval 58.41 to 80.42
|
—
|
—
|
|
Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 32, 48, 64: Period 2
Week 64
|
75.0 percentage of participants
Interval 60.17 to 86.36
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 3 baseline (last visit before retreatment), Week 64, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). Improvement was relative to period 3 baseline (last visit before retreatment).
Outcome measures
| Measure |
Etanercept
n=82 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 64, 76: Period 3
Week 64
|
26.7 percentage of participants
Interval 9.74 to 51.66
|
—
|
—
|
|
Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 64, 76: Period 3
Week 76
|
80.5 percentage of participants
Interval 70.94 to 87.93
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 12, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). The improvement was relative to baseline (Day 1).
Outcome measures
| Measure |
Etanercept
n=197 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 12, 24: Period 1
Week 12
|
62.4 percentage of participants
Interval 55.53 to 68.98
|
—
|
—
|
|
Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 12, 24: Period 1
Week 24
|
73.7 percentage of participants
Interval 67.0 to 79.59
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 2 baseline (last visit before treatment withdrawal), Week 32, 48, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). Improvement was relative to period 2 baseline (last visit before treatment withdrawal).
Outcome measures
| Measure |
Etanercept
n=103 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 32, 48, 64: Period 2
Week 32
|
65.0 percentage of participants
Interval 55.53 to 73.74
|
—
|
—
|
|
Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 32, 48, 64: Period 2
Week 48
|
59.4 percentage of participants
Interval 47.15 to 70.78
|
—
|
—
|
|
Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 32, 48, 64: Period 2
Week 64
|
62.5 percentage of participants
Interval 47.05 to 76.21
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 3 baseline (last visit before retreatment), Week 64, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). Improvement was relative to period 3 baseline (last visit before retreatment).
Outcome measures
| Measure |
Etanercept
n=82 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 64, 76: Period 3
Week 64
|
20.0 percentage of participants
Interval 5.98 to 44.36
|
—
|
—
|
|
Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 64, 76: Period 3
Week 76
|
74.4 percentage of participants
Interval 64.21 to 82.88
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 12, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value).
Outcome measures
| Measure |
Etanercept
n=193 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 12, 24: Observed Cases (OC): Period 1
Baseline
|
44.23 units on a scale
Standard Deviation 10.69
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 12, 24: Observed Cases (OC): Period 1
Change at week 12
|
5.24 units on a scale
Standard Deviation 9.36
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 12, 24: Observed Cases (OC): Period 1
Change at week 24
|
9.23 units on a scale
Standard Deviation 10.52
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value).
Outcome measures
| Measure |
Etanercept
n=114 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Observed Cases (OC): Period 2
Period 2 Baseline
|
55.06 units on a scale
Standard Deviation 6.33
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 32 from Period 1 Baseline
|
5.71 units on a scale
Standard Deviation 10.19
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 32 from Period 2 Baseline
|
-3.74 units on a scale
Standard Deviation 8.00
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 48 from Period 1 Baseline
|
6.36 units on a scale
Standard Deviation 9.36
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 48 from Period 2 Baseline
|
-3.19 units on a scale
Standard Deviation 7.68
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 64 from Period 1 Baseline
|
4.99 units on a scale
Standard Deviation 9.14
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 64 from Period 2 Baseline
|
-3.86 units on a scale
Standard Deviation 8.39
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value).
Outcome measures
| Measure |
Etanercept
n=82 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 76 from Period 3 Baseline
|
4.24 units on a scale
Standard Deviation 7.61
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Observed Cases (OC): Period 3
Period 3 Baseline
|
47.95 units on a scale
Standard Deviation 9.16
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 64 from Period 1 Baseline
|
0.92 units on a scale
Standard Deviation 8.80
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 64 from Period 2 Baseline
|
-7.66 units on a scale
Standard Deviation 9.63
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 64 from Period 3 Baseline
|
0.46 units on a scale
Standard Deviation 4.25
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 76 from Period 1 Baseline
|
8.81 units on a scale
Standard Deviation 9.87
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 76 from Period 2 Baseline
|
-2.13 units on a scale
Standard Deviation 7.00
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 12, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Missing data was imputed using mixed LOCF. Overall Number of Participants Analyzed" = participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value).
Outcome measures
| Measure |
Etanercept
n=193 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Baseline
|
44.23 units on a scale
Standard Deviation 10.69
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Change at week 12
|
5.24 units on a scale
Standard Deviation 9.36
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Change at week 24
|
8.39 units on a scale
Standard Deviation 10.69
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Missing data was imputed using mixed LOCF. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value).
Outcome measures
| Measure |
Etanercept
n=114 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Period 2 Baseline
|
55.06 units on a scale
Standard Deviation 6.33
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 32 from Period 1 Baseline
|
5.71 units on a scale
Standard Deviation 10.19
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 32 from Period 2 Baseline
|
-3.74 units on a scale
Standard Deviation 8.00
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 1 Baseline
|
5.83 units on a scale
Standard Deviation 9.15
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 2 Baseline
|
-3.99 units on a scale
Standard Deviation 8.14
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 1 Baseline
|
5.17 units on a scale
Standard Deviation 9.15
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 2 Baseline
|
-4.84 units on a scale
Standard Deviation 8.31
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76Population: FAS Period 3: all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Missing data was imputed using mixed LOCF. Overall Number of Participants Analyzed" = participants who were evaluable for this outcome measure and "number analyzed" = participants evaluable at specific time points.
SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value).
Outcome measures
| Measure |
Etanercept
n=82 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Period 3 Baseline
|
47.95 units on a scale
Standard Deviation 9.16
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 1 Baseline
|
0.92 units on a scale
Standard Deviation 8.80
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 2 Baseline
|
-7.66 units on a scale
Standard Deviation 9.63
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 3 Baseline
|
0.46 units on a scale
Standard Deviation 4.25
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 1 Baseline
|
8.81 units on a scale
Standard Deviation 9.87
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 2 Baseline
|
-2.13 units on a scale
Standard Deviation 7.00
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 3 Baseline
|
4.24 units on a scale
Standard Deviation 7.61
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 12, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). Improvement was relative to baseline (Day 1).
Outcome measures
| Measure |
Etanercept
n=197 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 12, 24: Period 1
Week 12
|
52.8 percentage of participants
Interval 45.82 to 59.68
|
—
|
—
|
|
Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 12, 24: Period 1
Week 24
|
67.2 percentage of participants
Interval 60.23 to 73.65
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 2 baseline (last visit before treatment withdrawal), Week 32, 48, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). Improvement was relative to period 2 baseline (last visit before treatment withdrawal).
Outcome measures
| Measure |
Etanercept
n=103 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Period 2
Week 32
|
59.2 percentage of participants
Interval 49.59 to 68.35
|
—
|
—
|
|
Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Period 2
Week 48
|
54.7 percentage of participants
Interval 42.51 to 66.45
|
—
|
—
|
|
Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Period 2
Week 64
|
60.0 percentage of participants
Interval 44.56 to 74.05
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 3 baseline (last visit before retreatment), Week 64, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). Improvement was relative to period 3 baseline (last visit before retreatment).
Outcome measures
| Measure |
Etanercept
n=82 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Period 3
Week 64
|
26.7 percentage of participants
Interval 9.74 to 51.66
|
—
|
—
|
|
Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Period 3
Week 76
|
64.6 percentage of participants
Interval 53.92 to 74.33
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 12, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). The improvement was relative to baseline (Day 1).
Outcome measures
| Measure |
Etanercept
n=197 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 12, 24: Period 1
Week 12
|
45.2 percentage of participants
Interval 38.34 to 52.16
|
—
|
—
|
|
Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 12, 24: Period 1
Week 24
|
59.7 percentage of participants
Interval 52.52 to 66.53
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 2 baseline (last visit before treatment withdrawal), Week 32, 48, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). Improvement was relative to period 2 baseline (last visit before treatment withdrawal).
Outcome measures
| Measure |
Etanercept
n=103 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Period 2
Week 32
|
48.5 percentage of participants
Interval 39.04 to 58.12
|
—
|
—
|
|
Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Period 2
Week 48
|
45.3 percentage of participants
Interval 33.55 to 57.49
|
—
|
—
|
|
Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Period 2
Week 64
|
40.0 percentage of participants
Interval 25.95 to 55.44
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 3 baseline (last visit before retreatment), Week 64, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). Improvement was relative to period 3 baseline (last visit before retreatment).
Outcome measures
| Measure |
Etanercept
n=82 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Period 3
Week 64
|
6.7 percentage of participants
Interval 0.73 to 27.18
|
—
|
—
|
|
Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Period 3
Week 76
|
56.1 percentage of participants
Interval 45.3 to 66.47
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24Population: FAS for Period 1 included all participants who took study medication and had one evaluation after baseline. Here, "Overall Number of Participants Analyzed" included participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem here "ankylosing spondylitis (AS)" affected work attendance, work productivity and productivity in non-work regular activities. Participants were asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Etanercept
n=140 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 1
Baseline
|
50.79 units on a scale
Standard Deviation 28.13
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 1
Change at week 4
|
-15.19 units on a scale
Standard Deviation 23.82
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 1
Change at week 8
|
-21.44 units on a scale
Standard Deviation 27.58
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 1
Change at week 12
|
-21.83 units on a scale
Standard Deviation 30.13
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 1
Change at week 16
|
-27.58 units on a scale
Standard Deviation 27.62
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 1
Change at week 24
|
-35.08 units on a scale
Standard Deviation 27.14
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem here "AS" affected work attendance, work productivity and productivity in non-work regular activities. Participants were asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Etanercept
n=92 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 2
Period 2 Baseline
|
10.11 units on a scale
Standard Deviation 13.05
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 2
Change at Week 28 from Period 1 Baseline
|
-31.56 units on a scale
Standard Deviation 32.37
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 2
Change at Week 28 from Period 2 Baseline
|
6.87 units on a scale
Standard Deviation 18.67
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 2
Change at Week 32 from Period 1 Baseline
|
-31.00 units on a scale
Standard Deviation 30.35
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 2
Change at Week 32 from Period 2 Baseline
|
9.70 units on a scale
Standard Deviation 19.21
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 2
Change at Week 40 from Period 1 Baseline
|
-25.71 units on a scale
Standard Deviation 32.40
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 2
Change at Week 40 from Period 2 Baseline
|
14.12 units on a scale
Standard Deviation 24.99
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 2
Change at Week 48 from Period 1 Baseline
|
-22.86 units on a scale
Standard Deviation 31.58
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 2
Change at Week 48 from Period 2 Baseline
|
20.56 units on a scale
Standard Deviation 26.07
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 2
Change at Week 56 from Period 1 Baseline
|
-32.14 units on a scale
Standard Deviation 30.11
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 2
Change at Week 56 from Period 2 Baseline
|
6.77 units on a scale
Standard Deviation 21.35
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 2
Change at Week 64 from Period 1 Baseline
|
-19.17 units on a scale
Standard Deviation 26.53
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 2
Change at Week 64 from Period 2 Baseline
|
20.77 units on a scale
Standard Deviation 37.19
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem here "AS" affected work attendance, work productivity and productivity in non-work regular activities. Participants were asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Etanercept
n=67 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 3
Change at Week 68 from Period 3 Baseline
|
-22.83 units on a scale
Standard Deviation 25.78
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 3
Period 3 Baseline
|
45.37 units on a scale
Standard Deviation 29.20
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 3
Change at Week 64 from Period 1 Baseline
|
8.00 units on a scale
Standard Deviation 33.93
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 3
Change at Week 64 from Period 2 Baseline
|
43.64 units on a scale
Standard Deviation 22.48
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 3
Change at Week 64 from Period 3 Baseline
|
13.00 units on a scale
Standard Deviation 30.57
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 3
Change at Week 68 from Period 1 Baseline
|
-26.32 units on a scale
Standard Deviation 30.86
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 3
Change at Week 68 from Period 2 Baseline
|
13.67 units on a scale
Standard Deviation 22.09
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 3
Change at Week 72 from Period 1 Baseline
|
-32.03 units on a scale
Standard Deviation 29.58
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 3
Change at Week 72 from Period 2 Baseline
|
7.97 units on a scale
Standard Deviation 18.10
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 3
Change at Week 72 from Period 3 Baseline
|
-29.05 units on a scale
Standard Deviation 23.88
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 3
Change at Week 76 from Period 1 Baseline
|
-34.41 units on a scale
Standard Deviation 27.68
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 3
Change at Week 76 from Period 2 Baseline
|
6.45 units on a scale
Standard Deviation 13.92
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 3
Change at Week 76 from Period 3 Baseline
|
-30.49 units on a scale
Standard Deviation 26.55
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24Population: FAS for Period 1 included all participants who took study medication and had one evaluation after baseline. Missing data was imputed using mixed LOCF .Here, "Overall Number of Participants Analyzed" included participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem here "AS" affected work attendance, work productivity and productivity in non-work regular activities. Participants were asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Etanercept
n=140 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 1
Baseline
|
50.79 units on a scale
Standard Deviation 28.13
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 1
Change at week 4
|
-15.19 units on a scale
Standard Deviation 23.82
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 1
Change at week 8
|
-21.25 units on a scale
Standard Deviation 27.36
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 1
Change at week 12
|
-20.44 units on a scale
Standard Deviation 29.18
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 1
Change at week 16
|
-24.53 units on a scale
Standard Deviation 28.31
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 1
Change at week 24
|
-29.93 units on a scale
Standard Deviation 29.27
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Missing data was imputed using mixed LOCF. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem here "AS" affected work attendance, work productivity and productivity in non-work regular activities. Participants were asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Etanercept
n=92 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 2
Period 2 Baseline
|
10.11 units on a scale
Standard Deviation 13.05
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 2
Change at Week 28 from Period 1 Baseline
|
-31.56 units on a scale
Standard Deviation 32.37
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 2
Change at Week 28 from Period 2 Baseline
|
6.87 units on a scale
Standard Deviation 18.67
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 2
Change at Week 32 from Period 1 Baseline
|
-24.94 units on a scale
Standard Deviation 34.34
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 2
Change at Week 32 from Period 2 Baseline
|
13.41 units on a scale
Standard Deviation 21.36
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 2
Change at Week 40 from Period 1 Baseline
|
-19.87 units on a scale
Standard Deviation 35.68
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 2
Change at Week 40 from Period 2 Baseline
|
18.12 units on a scale
Standard Deviation 24.76
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 1 Baseline
|
-17.22 units on a scale
Standard Deviation 35.26
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 2 Baseline
|
20.71 units on a scale
Standard Deviation 25.49
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 2
Change at Week 56 from Period 1 Baseline
|
-17.97 units on a scale
Standard Deviation 35.13
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 2
Change at Week 56 from Period 2 Baseline
|
19.43 units on a scale
Standard Deviation 25.76
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 1 Baseline
|
-12.91 units on a scale
Standard Deviation 33.97
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 2 Baseline
|
25.06 units on a scale
Standard Deviation 29.49
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76Population: FAS Period 3: all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Missing data was imputed using mixed LOCF. Overall Number of Participants Analyzed" = participants who were evaluable for this outcome measure and "number analyzed" = participants evaluable at specific time points.
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem here "AS" affected work attendance, work productivity and productivity in non-work regular activities. Participants were asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Etanercept
n=67 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 3
Period 3 Baseline
|
45.37 units on a scale
Standard Deviation 29.20
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 1 Baseline
|
8.00 units on a scale
Standard Deviation 33.93
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 2 Baseline
|
43.64 units on a scale
Standard Deviation 22.48
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 3 Baseline
|
13.00 units on a scale
Standard Deviation 30.57
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 3
Change at Week 68 from Period 1 Baseline
|
-25.25 units on a scale
Standard Deviation 30.98
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 3
Change at Week 68 from Period 2 Baseline
|
14.92 units on a scale
Standard Deviation 22.35
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 3
Change at Week 68 from Period 3 Baseline
|
-22.06 units on a scale
Standard Deviation 25.41
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 3
Change at Week 72 from Period 1 Baseline
|
-31.67 units on a scale
Standard Deviation 29.47
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 3
Change at Week 72 from Period 2 Baseline
|
8.46 units on a scale
Standard Deviation 18.39
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 3
Change at Week 72 from Period 3 Baseline
|
-28.44 units on a scale
Standard Deviation 24.18
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 1 Baseline
|
-33.83 units on a scale
Standard Deviation 27.81
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 2 Baseline
|
6.46 units on a scale
Standard Deviation 13.74
|
—
|
—
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 3 Baseline
|
-29.69 units on a scale
Standard Deviation 26.24
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Missing data was imputed using mixed LOCF. Overall Number of Participants Analyzed" = participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
Change from baseline in MRI score of spine was assessed using SPARCC method. Scoring was based on 6 consecutive coronal slices from posterior to anterior. Each joint was divided into 4 quadrants. Each quadrant was assigned score of 0=no lesion or 1=increased signal. This part of coring allows for total score ranging from 0-8 for the 2 joints of one coronal slice. For each slice, score was increased by 1 for each joint that exhibits an intense signal in any quadrant (thereby allowing for an increase of up to 2 points in total score for each slice). Also, for each slice, an additional score of 1 was given for each joint that includes a lesion demonstrating continuous increased signal of depth \>=1 cm from articular surface (thereby allowing for an additional increase of up to 2 points for each slice). The total minimum and maximum score for all joints across 6 slices was 0 to 72 where higher scores reflecting worse disease.
Outcome measures
| Measure |
Etanercept
n=204 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 24: Last Observation Carried Forward (LOCF): Period 1
Baseline
|
8.48 units on a scale
Standard Deviation 12.83
|
—
|
—
|
|
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 24: Last Observation Carried Forward (LOCF): Period 1
Change at week 24
|
-6.08 units on a scale
Standard Deviation 11.71
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 48, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Missing data was imputed using mixed LOCF. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
Change from baseline in MRI score of spine was assessed using SPARCC method. Scoring was based on 6 consecutive coronal slices from posterior to anterior. Each joint was divided into 4 quadrants. Each quadrant was assigned score of 0=no lesion or 1=increased signal. This part of coring allows for total score ranging from 0-8 for the 2 joints of one coronal slice. For each slice, score was increased by 1 for each joint that exhibits an intense signal in any quadrant (thereby allowing for an increase of up to 2 points in total score for each slice). Also, for each slice, an additional score of 1 was given for each joint that includes a lesion demonstrating continuous increased signal of depth \>=1 cm from articular surface (thereby allowing for an additional increase of up to 2 points for each slice). The total minimum and maximum score for all joints across 6 slices was 0 to 72 where higher scores reflecting worse disease.
Outcome measures
| Measure |
Etanercept
n=68 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 2 Baseline
|
1.45 units on a scale
Standard Deviation 4.43
|
—
|
—
|
|
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 1 Baseline
|
-6.04 units on a scale
Standard Deviation 12.99
|
—
|
—
|
|
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 2 Baseline
|
2.07 units on a scale
Standard Deviation 5.32
|
—
|
—
|
|
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 48, 64: Last Observation Carried Forward (LOCF): Period 2
Period 2 Baseline
|
2.41 units on a scale
Standard Deviation 3.59
|
—
|
—
|
|
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 1 Baseline
|
-6.81 units on a scale
Standard Deviation 13.74
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76Population: FAS Period 3: all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Missing data was imputed using mixed LOCF. Overall Number of Participants Analyzed" = participants who were evaluable for this outcome measure and "number analyzed" = participants evaluable at specific time points.
Change from baseline in MRI score of spine was assessed using SPARCC method. Scoring was based on 6 consecutive coronal slices from posterior to anterior. Each joint was divided into 4 quadrants. Each quadrant was assigned score of 0=no lesion or 1=increased signal. This part of coring allows for total score ranging from 0-8 for the 2 joints of one coronal slice. For each slice, score was increased by 1 for each joint that exhibits an intense signal in any quadrant (thereby allowing for an increase of up to 2 points in total score for each slice). Also, for each slice, an additional score of 1 was given for each joint that includes a lesion demonstrating continuous increased signal of depth \>=1 cm from articular surface (thereby allowing for an additional increase of up to 2 points for each slice). The total minimum and maximum score for all joints across 6 slices was 0 to 72 where higher scores reflecting worse disease.
Outcome measures
| Measure |
Etanercept
n=78 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Period 3 Baseline
|
3.98 units on a scale
Standard Deviation 7.28
|
—
|
—
|
|
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 1 Baseline
|
-5.17 units on a scale
Standard Deviation 8.16
|
—
|
—
|
|
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 2 Baseline
|
-2.00 units on a scale
Standard Deviation 3.37
|
—
|
—
|
|
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 3 Baseline
|
4.75 units on a scale
Standard Deviation 11.53
|
—
|
—
|
|
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 1 Baseline
|
-8.44 units on a scale
Standard Deviation 12.92
|
—
|
—
|
|
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 2 Baseline
|
-1.41 units on a scale
Standard Deviation 3.28
|
—
|
—
|
|
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 3 Baseline
|
-1.96 units on a scale
Standard Deviation 8.84
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
Change from baseline in MRI score of spine was assessed using SPARCC method. Scoring was based on 6 consecutive coronal slices from posterior to anterior. Each joint was divided into 4 quadrants. Each quadrant was assigned score of 0=no lesion or 1=increased signal. This part of coring allows for total score ranging from 0-8 for the 2 joints of one coronal slice. For each slice, score was increased by 1 for each joint that exhibits an intense signal in any quadrant (thereby allowing for an increase of up to 2 points in total score for each slice). Also, for each slice, an additional score of 1 was given for each joint that includes a lesion demonstrating continuous increased signal of depth \>=1 cm from articular surface (thereby allowing for an additional increase of up to 2 points for each slice). The total minimum and maximum score for all joints across 6 slices was 0 to 72 where higher scores reflecting worse disease.
Outcome measures
| Measure |
Etanercept
n=204 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 24: Observed Cases (OC): Period 1
Baseline
|
8.48 units on a scale
Standard Deviation 12.83
|
—
|
—
|
|
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 24: Observed Cases (OC): Period 1
Change at week 24
|
-6.08 units on a scale
Standard Deviation 11.71
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 48, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
Change from baseline in MRI score of spine was assessed using SPARCC method. Scoring was based on 6 consecutive coronal slices from posterior to anterior. Each joint was divided into 4 quadrants. Each quadrant was assigned score of 0=no lesion or 1=increased signal. This part of coring allows for total score ranging from 0-8 for the 2 joints of one coronal slice. For each slice, score was increased by 1 for each joint that exhibits an intense signal in any quadrant (thereby allowing for an increase of up to 2 points in total score for each slice). Also, for each slice, an additional score of 1 was given for each joint that includes a lesion demonstrating continuous increased signal of depth \>=1 cm from articular surface (thereby allowing for an additional increase of up to 2 points for each slice). The total minimum and maximum score for all joints across 6 slices was 0 to 72 where higher scores reflecting worse disease.
Outcome measures
| Measure |
Etanercept
n=68 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 48, 64: Observed Cases (OC): Period 2
Period 2 Baseline
|
2.41 units on a scale
Standard Deviation 3.59
|
—
|
—
|
|
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 48, 64: Observed Cases (OC): Period 2
Change at Week 64 from Period 2 Baseline
|
0.37 units on a scale
Standard Deviation 1.12
|
—
|
—
|
|
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 48, 64: Observed Cases (OC): Period 2
Change at Week 48 from Period 1 Baseline
|
-6.04 units on a scale
Standard Deviation 12.99
|
—
|
—
|
|
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 48, 64: Observed Cases (OC): Period 2
Change at Week 48 from Period 2 Baseline
|
2.07 units on a scale
Standard Deviation 5.32
|
—
|
—
|
|
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 48, 64: Observed Cases (OC): Period 2
Change at Week 64 from Period 1 Baseline
|
-5.96 units on a scale
Standard Deviation 13.83
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
Change from baseline in MRI score of spine was assessed using SPARCC method. Scoring was based on 6 consecutive coronal slices from posterior to anterior. Each joint was divided into 4 quadrants. Each quadrant was assigned score of 0=no lesion or 1=increased signal. This part of coring allows for total score ranging from 0-8 for the 2 joints of one coronal slice. For each slice, score was increased by 1 for each joint that exhibits an intense signal in any quadrant (thereby allowing for an increase of up to 2 points in total score for each slice). Also, for each slice, an additional score of 1 was given for each joint that includes a lesion demonstrating continuous increased signal of depth \>=1 cm from articular surface (thereby allowing for an additional increase of up to 2 points for each slice). The total minimum and maximum score for all joints across 6 slices was 0 to 72 where higher scores reflecting worse disease.
Outcome measures
| Measure |
Etanercept
n=78 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 64, 76: Observed Cases (OC): Period 3
Period 3 Baseline
|
3.98 units on a scale
Standard Deviation 7.28
|
—
|
—
|
|
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 76 from Period 1 Baseline
|
-8.44 units on a scale
Standard Deviation 12.92
|
—
|
—
|
|
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 64 from Period 1 Baseline
|
-5.17 units on a scale
Standard Deviation 8.16
|
—
|
—
|
|
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 64 from Period 2 Baseline
|
-2.00 units on a scale
Standard Deviation 3.37
|
—
|
—
|
|
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 64 from Period 3 Baseline
|
4.75 units on a scale
Standard Deviation 11.53
|
—
|
—
|
|
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 76 from Period 2 Baseline
|
-1.41 units on a scale
Standard Deviation 3.28
|
—
|
—
|
|
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 76 from Period 3 Baseline
|
-1.96 units on a scale
Standard Deviation 8.84
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 12 weeks of Period 3 (retreatment period from Week 64 to 76)Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy.
Time to ASDAS inactive disease was defined as the time from first dose of retreatment until the first observed event of ASDAS inactive disease. Inactive disease is defined as an ASDAS score \<1.3. for ASDAS-CRP or ASDAS score of \>=2.1 for ASDAS-ESR. Participants who did not achieve ASDAS inactive disease were censored at the time of the last ASDAS evaluation in the interval.
Outcome measures
| Measure |
Etanercept
n=87 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Time to Ankylosing Spondylitis Disease Activity Score (ASDAS) Inactive Disease After Re-treatment in Period 3
|
5.1 weeks
Interval 4.29 to 8.14
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Here, "number analyzed" signifies participants evaluable at specific time points.
Participants assessed their overall disease activity over the last 48 hours by using a 100 mm pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes.
Outcome measures
| Measure |
Etanercept
n=209 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 1
Change at week 16
|
-3.90 cm
Standard Deviation 2.74
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 1
Change at week 24
|
-4.72 cm
Standard Deviation 2.71
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 1
Baseline
|
6.34 cm
Standard Deviation 2.14
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 1
Change at week 4
|
-2.48 cm
Standard Deviation 2.45
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 1
Change at week 8
|
-3.06 cm
Standard Deviation 2.71
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 1
Change at week 12
|
-3.44 cm
Standard Deviation 2.74
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Here, "number analyzed" signifies participants evaluable at specific time points.
Participants assessed their overall disease activity over the last 48 hours by using a 100 mm pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2
Change at Week 56 from Period 2 Baseline
|
1.48 cm
Standard Deviation 2.45
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2
Period 2 Baseline
|
0.61 cm
Standard Deviation 0.57
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2
Change at Week 28 from Period 1 Baseline
|
-4.08 cm
Standard Deviation 3.01
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2
Change at Week 28 from Period 2 Baseline
|
1.46 cm
Standard Deviation 2.47
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2
Change at Week 32 from Period 1 Baseline
|
-3.87 cm
Standard Deviation 3.07
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2
Change at Week 32 from Period 2 Baseline
|
1.68 cm
Standard Deviation 2.49
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2
Change at Week 40 from Period 1 Baseline
|
-3.62 cm
Standard Deviation 2.90
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2
Change at Week 40 from Period 2 Baseline
|
1.74 cm
Standard Deviation 2.47
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2
Change at Week 48 from Period 1 Baseline
|
-3.65 cm
Standard Deviation 2.73
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2
Change at Week 48 from Period 2 Baseline
|
1.81 cm
Standard Deviation 2.70
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2
Change at Week 56 from Period 1 Baseline
|
-3.67 cm
Standard Deviation 2.63
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2
Change at Week 64 from Period 1 Baseline
|
-3.07 cm
Standard Deviation 3.01
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2
Change at Week 64 from Period 2 Baseline
|
1.66 cm
Standard Deviation 2.95
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Here, "number analyzed" signifies participants evaluable at specific time points.
Participants assessed their overall disease activity over the last 48 hours by using a 100 mm pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes.
Outcome measures
| Measure |
Etanercept
n=87 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3
Change at Week 68 from Period 1 Baseline
|
-4.21 cm
Standard Deviation 2.64
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3
Change at Week 68 from Period 2 Baseline
|
1.63 cm
Standard Deviation 1.90
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3
Change at Week 68 from Period 3 Baseline
|
-4.09 cm
Standard Deviation 2.63
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3
Period 3 Baseline
|
6.27 cm
Standard Deviation 2.24
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3
Change at Week 64 from Period 1 Baseline
|
-0.26 cm
Standard Deviation 4.09
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3
Change at Week 64 from Period 2 Baseline
|
4.95 cm
Standard Deviation 2.35
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3
Change at Week 64 from Period 3 Baseline
|
0.67 cm
Standard Deviation 2.48
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3
Change at Week 72 from Period 1 Baseline
|
-4.60 cm
Standard Deviation 2.59
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3
Change at Week 72 from Period 2 Baseline
|
1.23 cm
Standard Deviation 1.87
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3
Change at Week 72 from Period 3 Baseline
|
-4.44 cm
Standard Deviation 2.64
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3
Change at Week 76 from Period 1 Baseline
|
-4.91 cm
Standard Deviation 2.50
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3
Change at Week 76 from Period 2 Baseline
|
1.01 cm
Standard Deviation 1.42
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3
Change at Week 76 from Period 3 Baseline
|
-4.75 cm
Standard Deviation 2.49
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
Participants assessed their overall disease activity over the last 48 hours by using a 100 mm pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes.
Outcome measures
| Measure |
Etanercept
n=209 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 1
Baseline
|
6.34 cm
Standard Deviation 2.14
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 1
Change at week 4
|
-2.48 cm
Standard Deviation 2.45
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 1
Change at week 8
|
-3.04 cm
Standard Deviation 2.69
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 1
Change at week 12
|
-3.35 cm
Standard Deviation 2.74
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 1
Change at week 16
|
-3.70 cm
Standard Deviation 2.80
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 1
Change at week 24
|
-4.45 cm
Standard Deviation 2.87
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
Participants assessed their overall disease activity over the last 48 hours by using a 100 mm pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2
Period 2 Baseline
|
0.61 cm
Standard Deviation 0.57
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2
Change at Week 28 from Period 1 Baseline
|
-4.08 cm
Standard Deviation 3.01
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2
Change at Week 28 from Period 2 Baseline
|
1.46 cm
Standard Deviation 2.47
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2
Change at Week 32 from Period 1 Baseline
|
-3.24 cm
Standard Deviation 3.33
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2
Change at Week 32 from Period 2 Baseline
|
2.27 cm
Standard Deviation 2.81
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2
Change at Week 40 from Period 1 Baseline
|
-2.73 cm
Standard Deviation 3.29
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2
Change at Week 40 from Period 2 Baseline
|
2.79 cm
Standard Deviation 2.92
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 1 Baseline
|
-2.33 cm
Standard Deviation 3.22
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 2 Baseline
|
3.18 cm
Standard Deviation 2.99
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2
Change at Week 56 from Period 1 Baseline
|
-2.09 cm
Standard Deviation 3.13
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2
Change at Week 56 from Period 2 Baseline
|
3.42 cm
Standard Deviation 3.00
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 1 Baseline
|
-1.81 cm
Standard Deviation 3.10
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 2 Baseline
|
3.71 cm
Standard Deviation 3.04
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
Participants assessed their overall disease activity over the last 48 hours by using a 100 mm pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes.
Outcome measures
| Measure |
Etanercept
n=87 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3
Period 3 Baseline
|
6.27 cm
Standard Deviation 2.24
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 1 Baseline
|
-0.26 cm
Standard Deviation 4.09
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 2 Baseline
|
4.95 cm
Standard Deviation 2.35
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 3 Baseline
|
0.67 cm
Standard Deviation 2.48
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3
Change at Week 68 from Period 1 Baseline
|
-4.17 cm
Standard Deviation 2.66
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3
Change at Week 68 from Period 2 Baseline
|
1.66 cm
Standard Deviation 1.91
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3
Change at Week 68 from Period 3 Baseline
|
-4.03 cm
Standard Deviation 2.66
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3
Change at Week 72 from Period 1 Baseline
|
-4.60 cm
Standard Deviation 2.59
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3
Change at Week 72 from Period 2 Baseline
|
1.23 cm
Standard Deviation 1.87
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3
Change at Week 72 from Period 3 Baseline
|
-4.44 cm
Standard Deviation 2.64
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 1 Baseline
|
-4.83 cm
Standard Deviation 2.54
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 2 Baseline
|
1.01 cm
Standard Deviation 1.43
|
—
|
—
|
|
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 3 Baseline
|
-4.66 cm
Standard Deviation 2.52
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
The physician assessed the overall disease activity of participants over the last 48 hours by using a 100 mm VAS pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes.
Outcome measures
| Measure |
Etanercept
n=208 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 1
Baseline
|
6.07 cm
Standard Deviation 1.88
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 1
Change at week 4
|
-2.89 cm
Standard Deviation 2.41
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 1
Change at week 8
|
-3.83 cm
Standard Deviation 2.52
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 1
Change at week 12
|
-4.16 cm
Standard Deviation 2.41
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 1
Change at week 16
|
-4.57 cm
Standard Deviation 2.39
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 1
Change at week 24
|
-4.81 cm
Standard Deviation 2.26
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Here, "number analyzed" signifies participants evaluable at specific time points.
The physician assessed the overall disease activity of participants over the last 48 hours by using a 100 mm VAS pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2
Change at Week 32 from Period 1 Baseline
|
-4.27 cm
Standard Deviation 2.61
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2
Period 2 Baseline
|
0.63 cm
Standard Deviation 0.82
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2
Change at Week 28 from Period 1 Baseline
|
-4.65 cm
Standard Deviation 2.50
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2
Change at Week 28 from Period 2 Baseline
|
0.92 cm
Standard Deviation 1.69
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2
Change at Week 32 from Period 2 Baseline
|
1.33 cm
Standard Deviation 1.92
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2
Change at Week 40 from Period 1 Baseline
|
-3.98 cm
Standard Deviation 3.22
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2
Change at Week 40 from Period 2 Baseline
|
1.59 cm
Standard Deviation 2.07
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2
Change at Week 48 from Period 1 Baseline
|
-4.78 cm
Standard Deviation 2.45
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2
Change at Week 48 from Period 2 Baseline
|
1.24 cm
Standard Deviation 1.97
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2
Change at Week 56 from Period 1 Baseline
|
-4.67 cm
Standard Deviation 2.45
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2
Change at Week 56 from Period 2 Baseline
|
1.16 cm
Standard Deviation 1.79
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2
Change at Week 64 from Period 1 Baseline
|
-4.22 cm
Standard Deviation 2.63
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2
Change at Week 64 from Period 2 Baseline
|
1.40 cm
Standard Deviation 2.42
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Here, "number analyzed" signifies participants evaluable at specific time points.
The physician assessed the overall disease activity of participants over the last 48 hours by using a 100 mm VAS pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes.
Outcome measures
| Measure |
Etanercept
n=87 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3
Period 3 Baseline
|
4.89 cm
Standard Deviation 1.99
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3
Change at Week 64 from Period 1 Baseline
|
-2.18 cm
Standard Deviation 2.91
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3
Change at Week 64 from Period 2 Baseline
|
4.52 cm
Standard Deviation 1.85
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3
Change at Week 64 from Period 3 Baseline
|
1.88 cm
Standard Deviation 2.21
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3
Change at Week 68 from Period 1 Baseline
|
-4.51 cm
Standard Deviation 2.15
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3
Change at Week 68 from Period 2 Baseline
|
1.06 cm
Standard Deviation 1.31
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3
Change at Week 68 from Period 3 Baseline
|
-3.17 cm
Standard Deviation 2.09
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3
Change at Week 72 from Period 1 Baseline
|
-4.89 cm
Standard Deviation 1.92
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3
Change at Week 72 from Period 2 Baseline
|
0.70 cm
Standard Deviation 1.09
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3
Change at Week 72 from Period 3 Baseline
|
-3.52 cm
Standard Deviation 2.25
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3
Change at Week 76 from Period 1 Baseline
|
-5.25 cm
Standard Deviation 1.98
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3
Change at Week 76 from Period 2 Baseline
|
0.34 cm
Standard Deviation 0.83
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3
Change at Week 76 from Period 3 Baseline
|
-3.95 cm
Standard Deviation 2.22
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Missing data was imputed using mixed LOCF. Overall Number of Participants Analyzed" = participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
The physician assessed the overall disease activity of participants over the last 48 hours by using a 100 mm VAS pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes.
Outcome measures
| Measure |
Etanercept
n=208 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 1
Baseline
|
6.07 cm
Standard Deviation 1.88
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 1
Change at week 4
|
-2.89 cm
Standard Deviation 2.41
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 1
Change at week 8
|
-3.76 cm
Standard Deviation 2.61
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 1
Change at week 12
|
-4.02 cm
Standard Deviation 2.56
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 1
Change at week 16
|
-4.32 cm
Standard Deviation 2.58
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 1
Change at week 24
|
-4.54 cm
Standard Deviation 2.51
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
The physician assessed the overall disease activity of participants over the last 48 hours by using a 100 mm VAS pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2
Period 2 Baseline
|
0.63 cm
Standard Deviation 0.82
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2
Change at Week 28 from Period 1 Baseline
|
-4.65 cm
Standard Deviation 2.50
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2
Change at Week 28 from Period 2 Baseline
|
0.92 cm
Standard Deviation 1.69
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2
Change at Week 32 from Period 1 Baseline
|
-3.91 cm
Standard Deviation 2.69
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2
Change at Week 32 from Period 2 Baseline
|
1.64 cm
Standard Deviation 2.11
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2
Change at Week 40 from Period 1 Baseline
|
-3.31 cm
Standard Deviation 3.04
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2
Change at Week 40 from Period 2 Baseline
|
2.24 cm
Standard Deviation 2.31
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 1 Baseline
|
-3.15 cm
Standard Deviation 3.00
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 2 Baseline
|
2.40 cm
Standard Deviation 2.43
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2
Change at Week 56 from Period 1 Baseline
|
-2.89 cm
Standard Deviation 2.93
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2
Change at Week 56 from Period 2 Baseline
|
2.65 cm
Standard Deviation 2.40
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 1 Baseline
|
-2.66 cm
Standard Deviation 2.88
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 2 Baseline
|
2.88 cm
Standard Deviation 2.53
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
The physician assessed the overall disease activity of participants over the last 48 hours by using a 100 mm VAS pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes.
Outcome measures
| Measure |
Etanercept
n=87 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3
Period 3 Baseline
|
4.89 cm
Standard Deviation 1.99
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 1 Baseline
|
-2.18 cm
Standard Deviation 2.91
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 2 Baseline
|
4.52 cm
Standard Deviation 1.85
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 3 Baseline
|
1.88 cm
Standard Deviation 2.21
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3
Change at Week 68 from Period 1 Baseline
|
-4.46 cm
Standard Deviation 2.19
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3
Change at Week 68 from Period 2 Baseline
|
1.12 cm
Standard Deviation 1.42
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3
Change at Week 68 from Period 3 Baseline
|
-3.10 cm
Standard Deviation 2.18
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3
Change at Week 72 from Period 1 Baseline
|
-4.89 cm
Standard Deviation 1.92
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3
Change at Week 72 from Period 2 Baseline
|
0.70 cm
Standard Deviation 1.09
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3
Change at Week 72 from Period 3 Baseline
|
-3.52 cm
Standard Deviation 2.25
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 1 Baseline
|
-5.22 cm
Standard Deviation 1.99
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 2 Baseline
|
0.37 cm
Standard Deviation 0.89
|
—
|
—
|
|
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 3 Baseline
|
-3.85 cm
Standard Deviation 2.27
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 12, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
The BAS-G was a 2-question assessment evaluating the effect of AS on the participants well-being over the last week and last 6 months. Each question scored by the participant on a 100 mm VAS scale ranging from 0 (very Good) to 100 (very Bad), where higher scores indicated worse health condition. The total BAS-G score calculated as the average scores of these two questions and then converted into cm for analysis. Total BAS-G score ranged from 0 to 10 cm, where higher scores indicated worse health condition.
Outcome measures
| Measure |
Etanercept
n=209 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Baseline
|
6.48 cm
Standard Deviation 1.93
|
—
|
—
|
|
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Change at week 12
|
-2.58 cm
Standard Deviation 2.25
|
—
|
—
|
|
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Change at week 24
|
-3.95 cm
Standard Deviation 2.64
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
The BAS-G was a 2-question assessment evaluating the effect of AS on the participants well-being over the last week and last 6 months. Each question scored by the participant on a 100 mm VAS scale ranging from 0 (very Good) to 100 (very Bad), where higher scores indicated worse health condition. The total BAS-G score calculated as the average scores of these two questions and then converted into cm for analysis. Total BAS-G score ranged from 0 to 10 cm, where higher scores indicated worse health condition.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Period 2 Baseline
|
1.39 cm
Standard Deviation 1.49
|
—
|
—
|
|
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 32 from Period 1 Baseline
|
-3.78 cm
Standard Deviation 2.79
|
—
|
—
|
|
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 32 from Period 2 Baseline
|
1.10 cm
Standard Deviation 2.22
|
—
|
—
|
|
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 1 Baseline
|
-3.04 cm
Standard Deviation 2.80
|
—
|
—
|
|
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 2 Baseline
|
1.84 cm
Standard Deviation 2.46
|
—
|
—
|
|
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 1 Baseline
|
-2.64 cm
Standard Deviation 2.72
|
—
|
—
|
|
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 2 Baseline
|
2.24 cm
Standard Deviation 2.58
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76Population: FAS Period 3: all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Missing data was imputed using mixed LOCF. Overall Number of Participants Analyzed" = participants who were evaluable for this outcome measure and "number analyzed" = participants evaluable at specific time points.
The BAS-G was a 2-question assessment evaluating the effect of AS on the participants well-being over the last week and last 6 months. Each question scored by the participant on a 100 mm VAS scale ranging from 0 (very Good) to 100 (very Bad), where higher scores indicated worse health condition. The total BAS-G score calculated as the average scores of these two questions and then converted into cm for analysis. Total BAS-G score ranged from 0 to 10 cm, where higher scores indicated worse health condition.
Outcome measures
| Measure |
Etanercept
n=86 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Period 3 Baseline
|
4.74 cm
Standard Deviation 2.02
|
—
|
—
|
|
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 1 Baseline
|
-2.23 cm
Standard Deviation 2.41
|
—
|
—
|
|
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 2 Baseline
|
2.94 cm
Standard Deviation 1.81
|
—
|
—
|
|
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 3 Baseline
|
0.83 cm
Standard Deviation 2.16
|
—
|
—
|
|
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 1 Baseline
|
-4.35 cm
Standard Deviation 2.46
|
—
|
—
|
|
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 2 Baseline
|
0.57 cm
Standard Deviation 1.74
|
—
|
—
|
|
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 3 Baseline
|
-2.53 cm
Standard Deviation 2.10
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 12, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Here, "number analyzed" signifies participants evaluable at specific time points.
The BAS-G was a 2-question assessment evaluating the effect of AS on the participants well-being over the last week and last 6 months. Each question scored by the participant on a 100 mm VAS scale ranging from 0 (very Good) to 100 (very Bad), where higher scores indicated worse health condition. The total BAS-G score calculated as the average scores of these two questions and then converted into cm for analysis. Total BAS-G score ranged from 0 to 10 cm, where higher scores indicated worse health condition.
Outcome measures
| Measure |
Etanercept
n=209 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 12, 24: Observed Cases (OC): Period 1
Baseline
|
6.48 cm
Standard Deviation 1.93
|
—
|
—
|
|
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 12, 24: Observed Cases (OC): Period 1
Change at week 12
|
-2.58 cm
Standard Deviation 2.25
|
—
|
—
|
|
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 12, 24: Observed Cases (OC): Period 1
Change at week 24
|
-4.11 cm
Standard Deviation 2.62
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Here, "number analyzed" signifies participants evaluable at specific time points.
The BAS-G was a 2-question assessment evaluating the effect of AS on the participants well-being over the last week and last 6 months. Each question scored by the participant on a 100 mm VAS scale ranging from 0 (very Good) to 100 (very Bad), where higher scores indicated worse health condition. The total BAS-G score calculated as the average scores of these two questions and then converted into cm for analysis. Total BAS-G score ranged from 0 to 10 cm, where higher scores indicated worse health condition.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score) at Week 32, 48, 64: Observed Cases (OC): Period 2
Period 2 Baseline
|
1.39 cm
Standard Deviation 1.49
|
—
|
—
|
|
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score) at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 32 from Period 1 Baseline
|
-3.78 cm
Standard Deviation 2.79
|
—
|
—
|
|
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score) at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 32 from Period 2 Baseline
|
1.10 cm
Standard Deviation 2.22
|
—
|
—
|
|
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score) at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 48 from Period 1 Baseline
|
-3.54 cm
Standard Deviation 2.51
|
—
|
—
|
|
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score) at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 48 from Period 2 Baseline
|
1.44 cm
Standard Deviation 2.37
|
—
|
—
|
|
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score) at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 64 from Period 1 Baseline
|
-3.52 cm
Standard Deviation 2.51
|
—
|
—
|
|
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score) at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 64 from Period 2 Baseline
|
1.58 cm
Standard Deviation 2.55
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
The BAS-G was a 2-question assessment evaluating the effect of AS on the participants well-being over the last week and last 6 months. Each question scored by the participant on a 100 mm VAS scale ranging from 0 (very Good) to 100 (very Bad), where higher scores indicated worse health condition. The total BAS-G score calculated as the average scores of these two questions and then converted into cm for analysis. Total BAS-G score ranged from 0 to 10 cm, where higher scores indicated worse health condition.
Outcome measures
| Measure |
Etanercept
n=86 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 76 from Period 3 Baseline
|
-2.53 cm
Standard Deviation 2.10
|
—
|
—
|
|
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 64, 76: Observed Cases (OC): Period 3
Period 3 Baseline
|
4.74 cm
Standard Deviation 2.02
|
—
|
—
|
|
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 64 from Period 1 Baseline
|
-2.23 cm
Standard Deviation 2.41
|
—
|
—
|
|
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 64 from Period 2 Baseline
|
2.94 cm
Standard Deviation 1.81
|
—
|
—
|
|
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 64 from Period 3 Baseline
|
0.83 cm
Standard Deviation 2.16
|
—
|
—
|
|
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 76 from Period 1 Baseline
|
-4.35 cm
Standard Deviation 2.46
|
—
|
—
|
|
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 76 from Period 2 Baseline
|
0.57 cm
Standard Deviation 1.74
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 12, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
Number of swollen joints was determined by examination of 44 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling =0, swelling =1.
Outcome measures
| Measure |
Etanercept
n=147 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Number of Swollen Joint Count at Week 12, 24: Observed Cases (OC): Period 1
Baseline
|
2.32 swollen joints
Standard Deviation 3.01
|
—
|
—
|
|
Change From Baseline in Number of Swollen Joint Count at Week 12, 24: Observed Cases (OC): Period 1
Change at week 12
|
-1.72 swollen joints
Standard Deviation 3.36
|
—
|
—
|
|
Change From Baseline in Number of Swollen Joint Count at Week 12, 24: Observed Cases (OC): Period 1
Change at week 24
|
-1.85 swollen joints
Standard Deviation 3.82
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
Number of swollen joints was determined by examination of 44 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling =0, swelling =1.
Outcome measures
| Measure |
Etanercept
n=77 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Number of Swollen Joint Count at Week 32, 48, 64: Observed Cases (OC): Period 2
Period 2 Baseline
|
0.95 swollen joints
Standard Deviation 1.89
|
—
|
—
|
|
Change From Baseline in Number of Swollen Joint Count at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 32 from Period 1 Baseline
|
-2.69 swollen joints
Standard Deviation 3.28
|
—
|
—
|
|
Change From Baseline in Number of Swollen Joint Count at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 32 from Period 2 Baseline
|
0.46 swollen joints
Standard Deviation 1.79
|
—
|
—
|
|
Change From Baseline in Number of Swollen Joint Count at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 48 from Period 1 Baseline
|
-1.64 swollen joints
Standard Deviation 2.40
|
—
|
—
|
|
Change From Baseline in Number of Swollen Joint Count at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 48 from Period 2 Baseline
|
-0.59 swollen joints
Standard Deviation 2.20
|
—
|
—
|
|
Change From Baseline in Number of Swollen Joint Count at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 64 from Period 1 Baseline
|
-0.82 swollen joints
Standard Deviation 2.27
|
—
|
—
|
|
Change From Baseline in Number of Swollen Joint Count at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 64 from Period 2 Baseline
|
0.36 swollen joints
Standard Deviation 2.62
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
Number of swollen joints was determined by examination of 44 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling =0, swelling =1.
Outcome measures
| Measure |
Etanercept
n=42 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Number of Swollen Joint Count at Week 64, 76: Observed Cases (OC): Period 3
Period 3: baseline
|
1.19 swollen joints
Standard Deviation 1.76
|
—
|
—
|
|
Change From Baseline in Number of Swollen Joint Count at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 64 from Period 1 Baseline
|
-0.67 swollen joints
Standard Deviation 1.03
|
—
|
—
|
|
Change From Baseline in Number of Swollen Joint Count at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 64 from Period 2 Baseline
|
1.17 swollen joints
Standard Deviation 2.48
|
—
|
—
|
|
Change From Baseline in Number of Swollen Joint Count at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 64 from Period 3 Baseline
|
0.33 swollen joints
Standard Deviation 1.53
|
—
|
—
|
|
Change From Baseline in Number of Swollen Joint Count at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 76 from Period 1 Baseline
|
-2.50 swollen joints
Standard Deviation 3.13
|
—
|
—
|
|
Change From Baseline in Number of Swollen Joint Count at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 76 from Period 2 Baseline
|
0.50 swollen joints
Standard Deviation 1.34
|
—
|
—
|
|
Change From Baseline in Number of Swollen Joint Count at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 76 from Period 3 Baseline
|
-0.88 swollen joints
Standard Deviation 1.96
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 12, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Missing data was imputed using mixed LOCF. Overall Number of Participants Analyzed" = participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
Number of swollen joints was determined by examination of 44 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling =0, swelling =1.
Outcome measures
| Measure |
Etanercept
n=147 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Number of Swollen Joint Count at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Baseline
|
2.32 swollen joints
Standard Deviation 3.01
|
—
|
—
|
|
Change From Baseline in Number of Swollen Joint Count at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Change at week 12
|
-1.72 swollen joints
Standard Deviation 3.36
|
—
|
—
|
|
Change From Baseline in Number of Swollen Joint Count at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Change at week 24
|
-1.92 swollen joints
Standard Deviation 3.52
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Missing data was imputed using mixed LOCF. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
Number of swollen joints was determined by examination of 44 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling =0, swelling =1.
Outcome measures
| Measure |
Etanercept
n=77 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Number of Swollen Joint Count at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Period 2 Baseline
|
0.95 swollen joints
Standard Deviation 1.89
|
—
|
—
|
|
Change From Baseline in Number of Swollen Joint Count at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 32 from Period 1 Baseline
|
-2.69 swollen joints
Standard Deviation 3.28
|
—
|
—
|
|
Change From Baseline in Number of Swollen Joint Count at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 32 from Period 2 Baseline
|
0.46 swollen joints
Standard Deviation 1.79
|
—
|
—
|
|
Change From Baseline in Number of Swollen Joint Count at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 1 Baseline
|
-2.24 swollen joints
Standard Deviation 3.00
|
—
|
—
|
|
Change From Baseline in Number of Swollen Joint Count at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 2 Baseline
|
-0.02 swollen joints
Standard Deviation 2.17
|
—
|
—
|
|
Change From Baseline in Number of Swollen Joint Count at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 1 Baseline
|
-2.00 swollen joints
Standard Deviation 3.05
|
—
|
—
|
|
Change From Baseline in Number of Swollen Joint Count at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 2 Baseline
|
0.04 swollen joints
Standard Deviation 2.37
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76Population: FAS Period 3: all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Missing data was imputed using mixed LOCF. Overall Number of Participants Analyzed" = participants who were evaluable for this outcome measure and "number analyzed" = participants evaluable at specific time points.
Number of swollen joints was determined by examination of 44 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling =0, swelling =1.
Outcome measures
| Measure |
Etanercept
n=42 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Number of Swollen Joint Count at Week 64, 76 : Last Observation Carried Forward (LOCF): Period 3
Period 3 Baseline
|
1.19 swollen joints
Standard Deviation 1.76
|
—
|
—
|
|
Change From Baseline in Number of Swollen Joint Count at Week 64, 76 : Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 1 Baseline
|
-0.67 swollen joints
Standard Deviation 1.03
|
—
|
—
|
|
Change From Baseline in Number of Swollen Joint Count at Week 64, 76 : Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 2 Baseline
|
1.17 swollen joints
Standard Deviation 2.48
|
—
|
—
|
|
Change From Baseline in Number of Swollen Joint Count at Week 64, 76 : Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 3 Baseline
|
0.33 swollen joints
Standard Deviation 1.53
|
—
|
—
|
|
Change From Baseline in Number of Swollen Joint Count at Week 64, 76 : Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 1 Baseline
|
-2.32 swollen joints
Standard Deviation 3.15
|
—
|
—
|
|
Change From Baseline in Number of Swollen Joint Count at Week 64, 76 : Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 2 Baseline
|
0.53 swollen joints
Standard Deviation 1.31
|
—
|
—
|
|
Change From Baseline in Number of Swollen Joint Count at Week 64, 76 : Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 3 Baseline
|
-0.72 swollen joints
Standard Deviation 2.02
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 12, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
Number of tender joints was determined by examining 44 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.
Outcome measures
| Measure |
Etanercept
n=147 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Number of Tender Joint Count at Week 12, 24: Observed Cases (OC): Period 1
Baseline
|
5.96 tender joints
Standard Deviation 5.44
|
—
|
—
|
|
Change From Baseline in Number of Tender Joint Count at Week 12, 24: Observed Cases (OC): Period 1
Change at week 12
|
-2.82 tender joints
Standard Deviation 4.86
|
—
|
—
|
|
Change From Baseline in Number of Tender Joint Count at Week 12, 24: Observed Cases (OC): Period 1
Change at week 24
|
-3.67 tender joints
Standard Deviation 5.72
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
Number of tender joints was determined by examining 44 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.
Outcome measures
| Measure |
Etanercept
n=77 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Number of Tender Joint Count at Week 32, 48, 64: Observed Cases (OC): Period 2
Period 2 Baseline
|
2.70 tender joints
Standard Deviation 2.58
|
—
|
—
|
|
Change From Baseline in Number of Tender Joint Count at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 32 from Period 1 Baseline
|
-3.27 tender joints
Standard Deviation 4.65
|
—
|
—
|
|
Change From Baseline in Number of Tender Joint Count at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 32 from Period 2 Baseline
|
0.61 tender joints
Standard Deviation 2.70
|
—
|
—
|
|
Change From Baseline in Number of Tender Joint Count at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 48 from Period 1 Baseline
|
-2.68 tender joints
Standard Deviation 3.71
|
—
|
—
|
|
Change From Baseline in Number of Tender Joint Count at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 48 from Period 2 Baseline
|
-0.73 tender joints
Standard Deviation 3.56
|
—
|
—
|
|
Change From Baseline in Number of Tender Joint Count at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 64 from Period 1 Baseline
|
-2.27 tender joints
Standard Deviation 2.28
|
—
|
—
|
|
Change From Baseline in Number of Tender Joint Count at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 64 from Period 2 Baseline
|
0.18 tender joints
Standard Deviation 3.74
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
Number of tender joints was determined by examining 44 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.
Outcome measures
| Measure |
Etanercept
n=42 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Number of Tender Joint Count at Week 64, 76: : Observed Cases (OC): Period 3
Change at Week 64 from Period 2 Baseline
|
0.33 tender joints
Standard Deviation 1.97
|
—
|
—
|
|
Change From Baseline in Number of Tender Joint Count at Week 64, 76: : Observed Cases (OC): Period 3
Change at Week 64 from Period 3 Baseline
|
0.00 tender joints
Standard Deviation 2.00
|
—
|
—
|
|
Change From Baseline in Number of Tender Joint Count at Week 64, 76: : Observed Cases (OC): Period 3
Change at Week 76 from Period 2 Baseline
|
0.06 tender joints
Standard Deviation 1.63
|
—
|
—
|
|
Change From Baseline in Number of Tender Joint Count at Week 64, 76: : Observed Cases (OC): Period 3
Period 3 Baseline
|
3.60 tender joints
Standard Deviation 2.80
|
—
|
—
|
|
Change From Baseline in Number of Tender Joint Count at Week 64, 76: : Observed Cases (OC): Period 3
Change at Week 64 from Period 1 Baseline
|
-0.17 tender joints
Standard Deviation 1.47
|
—
|
—
|
|
Change From Baseline in Number of Tender Joint Count at Week 64, 76: : Observed Cases (OC): Period 3
Change at Week 76 from Period 1 Baseline
|
-3.56 tender joints
Standard Deviation 2.91
|
—
|
—
|
|
Change From Baseline in Number of Tender Joint Count at Week 64, 76: : Observed Cases (OC): Period 3
Change at Week 76 from Period 3 Baseline
|
-1.94 tender joints
Standard Deviation 2.41
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 12, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Missing data was imputed using mixed LOCF. Overall Number of Participants Analyzed" = participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
Number of tender joints was determined by examining 44 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.
Outcome measures
| Measure |
Etanercept
n=147 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Number of Tender Joint Count at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Change at week 24
|
-3.15 tender joints
Standard Deviation 5.26
|
—
|
—
|
|
Change From Baseline in Number of Tender Joint Count at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Baseline
|
5.96 tender joints
Standard Deviation 5.44
|
—
|
—
|
|
Change From Baseline in Number of Tender Joint Count at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Change at week 12
|
-2.82 tender joints
Standard Deviation 4.86
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Missing data was imputed using mixed LOCF. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
Number of tender joints was determined by examining 44 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.
Outcome measures
| Measure |
Etanercept
n=77 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Number of Tender Joint Count at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Period 2 Baseline
|
2.70 tender joints
Standard Deviation 2.58
|
—
|
—
|
|
Change From Baseline in Number of Tender Joint Count at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 32 from Period 1 Baseline
|
-3.27 tender joints
Standard Deviation 4.65
|
—
|
—
|
|
Change From Baseline in Number of Tender Joint Count at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 32 from Period 2 Baseline
|
0.61 tender joints
Standard Deviation 2.70
|
—
|
—
|
|
Change From Baseline in Number of Tender Joint Count at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 1 Baseline
|
-2.88 tender joints
Standard Deviation 4.11
|
—
|
—
|
|
Change From Baseline in Number of Tender Joint Count at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 2 Baseline
|
-0.05 tender joints
Standard Deviation 3.37
|
—
|
—
|
|
Change From Baseline in Number of Tender Joint Count at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 1 Baseline
|
-2.72 tender joints
Standard Deviation 3.81
|
—
|
—
|
|
Change From Baseline in Number of Tender Joint Count at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 2 Baseline
|
-0.09 tender joints
Standard Deviation 3.47
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76Population: FAS Period 3: all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Missing data was imputed using mixed LOCF. Overall Number of Participants Analyzed" = participants who were evaluable for this outcome measure and "number analyzed" = participants evaluable at specific time points.
Number of tender joints was determined by examining 44 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.
Outcome measures
| Measure |
Etanercept
n=42 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Number of Tender Joint Count at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Period 3 Baseline
|
3.60 tender joints
Standard Deviation 2.80
|
—
|
—
|
|
Change From Baseline in Number of Tender Joint Count at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 1 Baseline
|
-0.17 tender joints
Standard Deviation 1.47
|
—
|
—
|
|
Change From Baseline in Number of Tender Joint Count at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 2 Baseline
|
0.33 tender joints
Standard Deviation 1.97
|
—
|
—
|
|
Change From Baseline in Number of Tender Joint Count at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 3 Baseline
|
0.00 tender joints
Standard Deviation 2.00
|
—
|
—
|
|
Change From Baseline in Number of Tender Joint Count at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 1 Baseline
|
-3.32 tender joints
Standard Deviation 3.02
|
—
|
—
|
|
Change From Baseline in Number of Tender Joint Count at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 2 Baseline
|
0.11 tender joints
Standard Deviation 1.59
|
—
|
—
|
|
Change From Baseline in Number of Tender Joint Count at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 3 Baseline
|
-1.72 tender joints
Standard Deviation 2.52
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 12, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Here, "number analyzed" signifies participants evaluable at specific time points.
Dactylitis is the inflammation of finger and/or toe joints (digits). Dactylitis scores was calculated by evaluating each of the 10 fingers and 10 toes. Each digit was evaluated on a 4-point scale ranging from of 0 to 3 where 0 = none, 1= mild, 2 = moderate, 3 = severe inflammation. The total score was calculated as the sum of scores for the 20 digits, total score ranged from 0 to 60, where higher scores indicated severe inflammation.
Outcome measures
| Measure |
Etanercept
n=209 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Dactylitis Total Score at Week 12, 24: Observed Cases (OC): Period 1
Baseline
|
0.42 units on a scale
Standard Deviation 1.43
|
—
|
—
|
|
Change From Baseline in Dactylitis Total Score at Week 12, 24: Observed Cases (OC): Period 1
Change at week 12
|
-0.27 units on a scale
Standard Deviation 1.45
|
—
|
—
|
|
Change From Baseline in Dactylitis Total Score at Week 12, 24: Observed Cases (OC): Period 1
Change at week 24
|
-0.30 units on a scale
Standard Deviation 1.44
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Here, "number analyzed" signifies participants evaluable at specific time points.
Dactylitis is the inflammation of finger and/or toe joints (digits). Dactylitis scores was calculated by evaluating each of the 10 fingers and 10 toes. Each digit was evaluated on a 4-point scale ranging from of 0 to 3 where 0 = none, 1= mild, 2 = moderate, 3 = severe inflammation. The total score was calculated as the sum of scores for the 20 digits, total score ranged from 0 to 60, where higher scores indicated severe inflammation.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Dactylitis Total Score at Week 32, 48, 64: Observed Cases (OC): Period 2
Period 2 Baseline
|
0.02 units on a scale
Standard Deviation 0.13
|
—
|
—
|
|
Change From Baseline in Dactylitis Total Score at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 32 from Period 1 Baseline
|
-0.42 units on a scale
Standard Deviation 1.32
|
—
|
—
|
|
Change From Baseline in Dactylitis Total Score at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 32 from Period 2 Baseline
|
0.01 units on a scale
Standard Deviation 0.22
|
—
|
—
|
|
Change From Baseline in Dactylitis Total Score at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 48 from Period 1 Baseline
|
-0.36 units on a scale
Standard Deviation 1.26
|
—
|
—
|
|
Change From Baseline in Dactylitis Total Score at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 48 from Period 2 Baseline
|
0.09 units on a scale
Standard Deviation 0.74
|
—
|
—
|
|
Change From Baseline in Dactylitis Total Score at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 64 from Period 1 Baseline
|
-0.57 units on a scale
Standard Deviation 1.61
|
—
|
—
|
|
Change From Baseline in Dactylitis Total Score at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 64 from Period 2 Baseline
|
0.07 units on a scale
Standard Deviation 0.34
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
Dactylitis is the inflammation of finger and/or toe joints (digits). Dactylitis scores was calculated by evaluating each of the 10 fingers and 10 toes. Each digit was evaluated on a 4-point scale ranging from of 0 to 3 where 0 = none, 1= mild, 2 = moderate, 3 = severe inflammation. The total score was calculated as the sum of scores for the 20 digits, total score ranged from 0 to 60, where higher scores indicated severe inflammation.
Outcome measures
| Measure |
Etanercept
n=86 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Dactylitis Total Score at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 64 from Period 2 Baseline
|
0.20 units on a scale
Standard Deviation 0.56
|
—
|
—
|
|
Change From Baseline in Dactylitis Total Score at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 64 from Period 3 Baseline
|
0.25 units on a scale
Standard Deviation 0.71
|
—
|
—
|
|
Change From Baseline in Dactylitis Total Score at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 76 from Period 2 Baseline
|
0.00 units on a scale
Standard Deviation 0.15
|
—
|
—
|
|
Change From Baseline in Dactylitis Total Score at Week 64, 76: Observed Cases (OC): Period 3
Period 3 Baseline
|
0.08 units on a scale
Standard Deviation 0.35
|
—
|
—
|
|
Change From Baseline in Dactylitis Total Score at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 64 from Period 1 Baseline
|
-0.33 units on a scale
Standard Deviation 1.05
|
—
|
—
|
|
Change From Baseline in Dactylitis Total Score at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 76 from Period 1 Baseline
|
-0.50 units on a scale
Standard Deviation 1.47
|
—
|
—
|
|
Change From Baseline in Dactylitis Total Score at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 76 from Period 3 Baseline
|
-0.06 units on a scale
Standard Deviation 0.37
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 12, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
Dactylitis is the inflammation of finger and/or toe joints (digits). Dactylitis scores was calculated by evaluating each of the 10 fingers and 10 toes. Each digit was evaluated on a 4-point scale ranging from of 0 to 3 where 0 = none, 1= mild, 2 = moderate, 3 = severe inflammation. The total score was calculated as the sum of scores for the 20 digits, total score ranged from 0 to 60, where higher scores indicated severe inflammation.
Outcome measures
| Measure |
Etanercept
n=209 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Dactylitis Total Score at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Baseline
|
0.42 units on a scale
Standard Deviation 1.43
|
—
|
—
|
|
Change From Baseline in Dactylitis Total Score at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Change at week 12
|
-0.27 units on a scale
Standard Deviation 1.45
|
—
|
—
|
|
Change From Baseline in Dactylitis Total Score at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Change at week 24
|
-0.28 units on a scale
Standard Deviation 1.38
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
Dactylitis is the inflammation of finger and/or toe joints (digits). Dactylitis scores was calculated by evaluating each of the 10 fingers and 10 toes. Each digit was evaluated on a 4-point scale ranging from of 0 to 3 where 0 = none, 1= mild, 2 = moderate, 3 = severe inflammation. The total score was calculated as the sum of scores for the 20 digits, total score ranged from 0 to 60, where higher scores indicated severe inflammation.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Dactylitis Total Score at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Period 2 Baseline
|
0.02 units on a scale
Standard Deviation 0.13
|
—
|
—
|
|
Change From Baseline in Dactylitis Total Score at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 32 from Period 1 Baseline
|
-0.42 units on a scale
Standard Deviation 1.32
|
—
|
—
|
|
Change From Baseline in Dactylitis Total Score at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 32 from Period 2 Baseline
|
0.01 units on a scale
Standard Deviation 0.22
|
—
|
—
|
|
Change From Baseline in Dactylitis Total Score at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 1 Baseline
|
-0.36 units on a scale
Standard Deviation 1.24
|
—
|
—
|
|
Change From Baseline in Dactylitis Total Score at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 2 Baseline
|
0.06 units on a scale
Standard Deviation 0.62
|
—
|
—
|
|
Change From Baseline in Dactylitis Total Score at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 1 Baseline
|
-0.39 units on a scale
Standard Deviation 1.28
|
—
|
—
|
|
Change From Baseline in Dactylitis Total Score at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 2 Baseline
|
0.04 units on a scale
Standard Deviation 0.30
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76Population: FAS Period 3: all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Missing data was imputed using mixed LOCF. Overall Number of Participants Analyzed" = participants who were evaluable for this outcome measure and "number analyzed" = participants evaluable at specific time points.
Dactylitis is the inflammation of finger and/or toe joints (digits). Dactylitis scores was calculated by evaluating each of the 10 fingers and 10 toes. Each digit was evaluated on a 4-point scale ranging from of 0 to 3 where 0 = none, 1= mild, 2 = moderate, 3 = severe inflammation. The total score was calculated as the sum of scores for the 20 digits, total score ranged from 0 to 60, where higher scores indicated severe inflammation.
Outcome measures
| Measure |
Etanercept
n=86 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Dactylitis Total Score at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 2 Baseline
|
0.20 units on a scale
Standard Deviation 0.56
|
—
|
—
|
|
Change From Baseline in Dactylitis Total Score at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Period 3 Baseline
|
0.08 units on a scale
Standard Deviation 0.35
|
—
|
—
|
|
Change From Baseline in Dactylitis Total Score at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 1 Baseline
|
-0.33 units on a scale
Standard Deviation 1.05
|
—
|
—
|
|
Change From Baseline in Dactylitis Total Score at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 3 Baseline
|
0.25 units on a scale
Standard Deviation 0.71
|
—
|
—
|
|
Change From Baseline in Dactylitis Total Score at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 1 Baseline
|
-0.50 units on a scale
Standard Deviation 1.47
|
—
|
—
|
|
Change From Baseline in Dactylitis Total Score at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 2 Baseline
|
0.00 units on a scale
Standard Deviation 0.15
|
—
|
—
|
|
Change From Baseline in Dactylitis Total Score at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 3 Baseline
|
-0.06 units on a scale
Standard Deviation 0.37
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 12, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
The MASES is an index used to measure the severity of enthesitis. Enthesitis is the inflammation of enthuses (heels). The MASES assesses 13 sites for enthesitis. Each site is scored as 0 or 1 depending on whether enthesitis is present or absent. Sites assessed include 1st costochondral joint (left/right), 7 th costochondral joint (l/r), posterior superior iliac spine (l/r), posterior anterior iliac spine (l/r), iliac crest (l/r), proximal insertion of Achilles tendon (l/r) and 5th lumbar spinous process. The MASES is the sum of all site scores range from 0 (no inflammation) to 13 (worst possible inflammation) where higher scores indicate more severe inflammation of entheses.
Outcome measures
| Measure |
Etanercept
n=208 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 12, 24: Observed Cases (OC) : Period 1
Baseline
|
2.86 units on a scale
Standard Deviation 2.98
|
—
|
—
|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 12, 24: Observed Cases (OC) : Period 1
Change at week 12
|
-1.22 units on a scale
Standard Deviation 2.55
|
—
|
—
|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 12, 24: Observed Cases (OC) : Period 1
Change at week 24
|
-1.59 units on a scale
Standard Deviation 2.59
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Here, "number analyzed" signifies participants evaluable at specific time points.
The MASES is an index used to measure the severity of enthesitis. Enthesitis is the inflammation of enthuses (heels). The MASES assesses 13 sites for enthesitis. Each site is scored as 0 or 1 depending on whether enthesitis is present or absent. Sites assessed include 1st costochondral joint (left/right), 7 th costochondral joint (l/r), posterior superior iliac spine (l/r), posterior anterior iliac spine (l/r), iliac crest (l/r), proximal insertion of Achilles tendon (l/r) and 5th lumbar spinous process. The MASES is the sum of all site scores range from 0 (no inflammation) to 13 (worst possible inflammation) where higher scores indicate more severe inflammation of entheses.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 48 from Period 2 Baseline
|
0.32 units on a scale
Standard Deviation 1.15
|
—
|
—
|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 32, 48, 64: Observed Cases (OC): Period 2
Period 2 Baseline
|
0.36 units on a scale
Standard Deviation 0.97
|
—
|
—
|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 32 from Period 1 Baseline
|
-1.06 units on a scale
Standard Deviation 2.49
|
—
|
—
|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 32 from Period 2 Baseline
|
0.71 units on a scale
Standard Deviation 1.76
|
—
|
—
|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 48 from Period 1 Baseline
|
-1.50 units on a scale
Standard Deviation 2.48
|
—
|
—
|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 64 from Period 1 Baseline
|
-1.37 units on a scale
Standard Deviation 2.30
|
—
|
—
|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 32, 48, 64: Observed Cases (OC): Period 2
Change at Week 64 from Period 2 Baseline
|
0.49 units on a scale
Standard Deviation 1.00
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76Population: Full analysis set for Period 3 included all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
The MASES is an index used to measure the severity of enthesitis. Enthesitis is the inflammation of enthuses (heels). The MASES assesses 13 sites for enthesitis. Each site is scored as 0 or 1 depending on whether enthesitis is present or absent. Sites assessed include 1st costochondral joint (left/right), 7 th costochondral joint (l/r), posterior superior iliac spine (l/r), posterior anterior iliac spine (l/r), iliac crest (l/r), proximal insertion of Achilles tendon (l/r) and 5th lumbar spinous process. The MASES is the sum of all site scores range from 0 (no inflammation) to 13 (worst possible inflammation) where higher scores indicate more severe inflammation of entheses.
Outcome measures
| Measure |
Etanercept
n=86 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 64, 76: Observed Cases (OC): Period 3
Period 3 Baseline
|
1.48 units on a scale
Standard Deviation 1.80
|
—
|
—
|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 64 from Period 1 Baseline
|
-1.13 units on a scale
Standard Deviation 2.03
|
—
|
—
|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 64 from Period 2 Baseline
|
0.67 units on a scale
Standard Deviation 2.13
|
—
|
—
|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 64 from Period 3 Baseline
|
0.14 units on a scale
Standard Deviation 0.90
|
—
|
—
|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 76 from Period 1 Baseline
|
-1.86 units on a scale
Standard Deviation 2.14
|
—
|
—
|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 76 from Period 2 Baseline
|
-0.06 units on a scale
Standard Deviation 1.13
|
—
|
—
|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 64, 76: Observed Cases (OC): Period 3
Change at Week 76 from Period 3 Baseline
|
-1.08 units on a scale
Standard Deviation 1.61
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Week 1), Week 12, 24Population: Full analysis set for Period 1 included all participants who took study medication and had one evaluation after baseline. Missing data was imputed using mixed LOCF. Overall Number of Participants Analyzed" = participants who were evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points.
The MASES is an index used to measure the severity of enthesitis. Enthesitis is the inflammation of enthuses (heels). The MASES assesses 13 sites for enthesitis. Each site is scored as 0 or 1 depending on whether enthesitis is present or absent. Sites assessed include 1st costochondral joint (left/right), 7 th costochondral joint (l/r), posterior superior iliac spine (l/r), posterior anterior iliac spine (l/r), iliac crest (l/r), proximal insertion of Achilles tendon (l/r) and 5th lumbar spinous process. The MASES is the sum of all site scores range from 0 (no inflammation) to 13 (worst possible inflammation) where higher scores indicate more severe inflammation of entheses.
Outcome measures
| Measure |
Etanercept
n=208 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Baseline
|
2.86 units on a scale
Standard Deviation 2.98
|
—
|
—
|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Change at week 12
|
-1.22 units on a scale
Standard Deviation 2.55
|
—
|
—
|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1
Change at week 24
|
-1.55 units on a scale
Standard Deviation 2.64
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2: Baseline (last visit before treatment withdrawal), Week 32, 48, 64Population: Full analysis set for Period 2 included all participants who had at least one evaluation during period 2. Missing data was imputed using mixed LOCF. Here, "number analyzed" signifies participants evaluable at specific time points.
The MASES is an index used to measure the severity of enthesitis. Enthesitis is the inflammation of enthuses (heels). The MASES assesses 13 sites for enthesitis. Each site is scored as 0 or 1 depending on whether enthesitis is present or absent. Sites assessed include 1st costochondral joint (left/right), 7 th costochondral joint (l/r), posterior superior iliac spine (l/r), posterior anterior iliac spine (l/r), iliac crest (l/r), proximal insertion of Achilles tendon (l/r) and 5th lumbar spinous process. The MASES is the sum of all site scores range from 0 (no inflammation) to 13 (worst possible inflammation) where higher scores indicate more severe inflammation of entheses.
Outcome measures
| Measure |
Etanercept
n=115 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 1 Baseline
|
-1.00 units on a scale
Standard Deviation 2.24
|
—
|
—
|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Period 2 Baseline
|
0.36 units on a scale
Standard Deviation 0.97
|
—
|
—
|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 32 from Period 1 Baseline
|
-1.06 units on a scale
Standard Deviation 2.49
|
—
|
—
|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 32 from Period 2 Baseline
|
0.71 units on a scale
Standard Deviation 1.76
|
—
|
—
|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 1 Baseline
|
-1.13 units on a scale
Standard Deviation 2.47
|
—
|
—
|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 48 from Period 2 Baseline
|
0.62 units on a scale
Standard Deviation 1.55
|
—
|
—
|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2
Change at Week 64 from Period 2 Baseline
|
0.75 units on a scale
Standard Deviation 1.55
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76Population: FAS Period 3: all participants who took study retreatment medication and had at least one evaluation after restarting active therapy. Missing data was imputed using mixed LOCF. Overall Number of Participants Analyzed" = participants who were evaluable for this outcome measure and "number analyzed" = participants evaluable at specific time points.
The MASES is an index used to measure the severity of enthesitis. Enthesitis is the inflammation of enthuses (heels). The MASES assesses 13 sites for enthesitis. Each site is scored as 0 or 1 depending on whether enthesitis is present or absent. Sites assessed include 1st costochondral joint (left/right), 7 th costochondral joint (l/r), posterior superior iliac spine (l/r), posterior anterior iliac spine (l/r), iliac crest (l/r), proximal insertion of Achilles tendon (l/r) and 5th lumbar spinous process. The MASES is the sum of all site scores range from 0 (no inflammation) to 13 (worst possible inflammation) where higher scores indicate more severe inflammation of entheses.
Outcome measures
| Measure |
Etanercept
n=86 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Period 3 Baseline
|
1.48 units on a scale
Standard Deviation 1.80
|
—
|
—
|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 3 Baseline
|
-1.08 units on a scale
Standard Deviation 1.61
|
—
|
—
|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 1 Baseline
|
-1.13 units on a scale
Standard Deviation 2.03
|
—
|
—
|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 2 Baseline
|
0.67 units on a scale
Standard Deviation 2.13
|
—
|
—
|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 64 from Period 3 Baseline
|
0.14 units on a scale
Standard Deviation 0.90
|
—
|
—
|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 1 Baseline
|
-1.86 units on a scale
Standard Deviation 2.14
|
—
|
—
|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3
Change at Week 76 from Period 2 Baseline
|
-0.06 units on a scale
Standard Deviation 1.13
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks)Population: Safety analysis set for each period included all participants who entered the period and for periods 1 and 3; all participants who received 1 dose of investigational drug.
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. Treatment-emergent were events between first dose of investigational product and up to 28 days after the last dose of investigational product that were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
Etanercept
n=209 Participants
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50-mg weekly dose of Etanercept in Period 1 (Induction Period). Participants who achieved ASDAS CRP level \< 1.3 at Week 24 entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks and participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept. Participants who did not qualify for Period 2 or 3 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
n=119 Participants
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
n=87 Participants
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
147 Participants
|
37 Participants
|
29 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
6 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Etanercept: Period 1
Etanercept: Period 2
Etanercept: Period 3
Serious adverse events
| Measure |
Etanercept: Period 1
n=209 participants at risk
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50 milligram weekly dose of Etanercept in Period 1 (Induction Period). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
n=119 participants at risk
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
n=87 participants at risk
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.48%
1/209 • Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/119 • Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/87 • Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
Cellulitis
|
0.48%
1/209 • Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/119 • Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/87 • Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.48%
1/209 • Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/119 • Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/87 • Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/209 • Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.84%
1/119 • Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/87 • Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.48%
1/209 • Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/119 • Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/87 • Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Nervous system disorders
Cerebral infarction
|
0.48%
1/209 • Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/119 • Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/87 • Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.48%
1/209 • Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/119 • Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/87 • Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
Other adverse events
| Measure |
Etanercept: Period 1
n=209 participants at risk
All enrolled participants with nr-ax SpA were treated for 24 weeks with 50 milligram weekly dose of Etanercept in Period 1 (Induction Period). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 2
n=119 participants at risk
Participants who achieved ASDAS CRP level less than 1.3 at Week 24 then entered into Period 2 (Withdrawal Period). In this period, participants discontinued Etanercept for 40 weeks (from Week 24 to Week 64). Participants who did not qualify for Period 2 were followed up until 28 days after last dose of Etanercept.
|
Etanercept: Period 3
n=87 participants at risk
Participants who achieved an ASDAS ESR level \>= 2.1 by Week 64, then entered into Period 3 (Retreatment Period) of 12 weeks, treated with 50 mg weekly doses, and then followed up until 28 days after last dose of Etanercept.
|
|---|---|---|---|
|
General disorders
Injection site erythema
|
7.2%
15/209 • Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/119 • Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/87 • Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
General disorders
Injection site reaction
|
7.2%
15/209 • Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/119 • Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/87 • Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.1%
19/209 • Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/119 • Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/87 • Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
15.8%
33/209 • Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/119 • Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
9.2%
8/87 • Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER