Trial Outcomes & Findings for Efficacy and Safety of Adalimumab in Adult Chinese Subjects With Active Ankylosing Spondylitis (NCT NCT01114880)
NCT ID: NCT01114880
Last Updated: 2011-12-01
Results Overview
ASAS20 responder had improvement of 20% or more and absolute improvement of at least 10 units (on a scale of 0 \[least\] to 100 \[worst\]) from Baseline in at least 3 of the following 4 domains, with absence of deterioration (change for worse of at least 20% and net worsening of at least 10 units) in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Bath Ankylosing Spondylitis Functional Index (BASFI); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] scores).
COMPLETED
PHASE3
344 participants
Week 12
2011-12-01
Participant Flow
Participant milestones
| Measure |
Adalimumab
Blinded adalimumab from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 22
|
Placebo
Blinded placebo from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 22
|
|---|---|---|
|
Period 1 (Week 0 to Week 12)
STARTED
|
229
|
115
|
|
Period 1 (Week 0 to Week 12)
COMPLETED
|
224
|
113
|
|
Period 1 (Week 0 to Week 12)
NOT COMPLETED
|
5
|
2
|
|
Period 2 (Week 12 to Week 24)
STARTED
|
224
|
113
|
|
Period 2 (Week 12 to Week 24)
COMPLETED
|
221
|
111
|
|
Period 2 (Week 12 to Week 24)
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Adalimumab
Blinded adalimumab from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 22
|
Placebo
Blinded placebo from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 22
|
|---|---|---|
|
Period 1 (Week 0 to Week 12)
Adverse Event
|
4
|
0
|
|
Period 1 (Week 0 to Week 12)
Withdrawal by Subject
|
1
|
0
|
|
Period 1 (Week 0 to Week 12)
Lost to Follow-up
|
0
|
1
|
|
Period 1 (Week 0 to Week 12)
Poor subject compliance
|
0
|
1
|
|
Period 2 (Week 12 to Week 24)
Adverse Event
|
3
|
0
|
|
Period 2 (Week 12 to Week 24)
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
Efficacy and Safety of Adalimumab in Adult Chinese Subjects With Active Ankylosing Spondylitis
Baseline characteristics by cohort
| Measure |
Adalimumab
n=229 Participants
Blinded adalimumab from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 22
|
Placebo
n=115 Participants
Blinded placebo from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 22
|
Total
n=344 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
30.1 years
STANDARD_DEVIATION 8.73 • n=5 Participants
|
29.6 years
STANDARD_DEVIATION 7.49 • n=7 Participants
|
29.9 years
STANDARD_DEVIATION 8.33 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
185 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
280 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
229 participants
n=5 Participants
|
115 participants
n=7 Participants
|
344 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Analysis was performed on the Intent-to-Treat (ITT) analysis set, which included all subjects who were randomized and received at least 1 dose of double-blind study drug. A non-responder (NRI) imputation was used in which a missing response was imputed as non-response.
ASAS20 responder had improvement of 20% or more and absolute improvement of at least 10 units (on a scale of 0 \[least\] to 100 \[worst\]) from Baseline in at least 3 of the following 4 domains, with absence of deterioration (change for worse of at least 20% and net worsening of at least 10 units) in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Bath Ankylosing Spondylitis Functional Index (BASFI); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] scores).
Outcome measures
| Measure |
Adalimumab/Adalimumab
n=229 Participants
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
Placebo/Adalimumab
n=115 Participants
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
|---|---|---|
|
Number of Participants Meeting the Assessment of Spondyloarthritis International Society (ASAS) ASAS20 Response Criteria
|
154 participants
|
35 participants
|
SECONDARY outcome
Timeframe: Week 24Population: ITT analysis set, missing data imputed by NRI
ASAS20 responder had improvement of 20% or more and absolute improvement of at least 10 units (on a scale of 0 \[least\] to 100 \[worst\]) from Baseline in at least 3 of the following 4 domains, with absence of deterioration (change for worse of at least 20% and net worsening of at least 10 units) in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Bath Ankylosing Spondylitis Functional Index (BASFI); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] scores).
Outcome measures
| Measure |
Adalimumab/Adalimumab
n=224 Participants
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
Placebo/Adalimumab
n=113 Participants
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
|---|---|---|
|
Number of Participants Meeting the ASAS20 Response Criteria
|
180 participants
|
85 participants
|
SECONDARY outcome
Timeframe: Week 12Population: ITT analysis set, missing data imputed by NRI
An ASAS40 responder had improvement of 40% or more and absolute improvement of 20 units or more (on a scale of 0 \[least\] to 100 \[worst\]) from Baseline in at least 3 of the 4 domains identified above for the ASAS20. In addition, there must have been an absence of deterioration in the potential remaining domain, where deterioration was defined as a net worsening of greater than 0 units (on a scale of 0 to 100).
Outcome measures
| Measure |
Adalimumab/Adalimumab
n=229 Participants
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
Placebo/Adalimumab
n=115 Participants
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
|---|---|---|
|
Number of Participants Meeting the ASAS40 Response Criteria
|
102 participants
|
11 participants
|
SECONDARY outcome
Timeframe: Week 24Population: ITT analysis set, missing data imputed by NRI
An ASAS40 responder had improvement of 40% or more and absolute improvement of 20 units or more (on a scale of 0 \[least\] to 100 \[worst\]) from Baseline in at least 3 of the 4 domains identified above for the ASAS20. In addition, there must have been an absence of deterioration in the potential remaining domain, where deterioration was defined as a net worsening of greater than 0 units (on a scale of 0 to 100).
Outcome measures
| Measure |
Adalimumab/Adalimumab
n=224 Participants
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
Placebo/Adalimumab
n=113 Participants
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
|---|---|---|
|
Number of Participants Meeting the ASAS40 Response Criteria
|
134 participants
|
63 participants
|
SECONDARY outcome
Timeframe: Week 12Population: ITT analysis set, missing data imputed by NRI
An ASAS5/6 responder had an improvement from Baseline of 20% or more in 5 of the following 6 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] scores); spinal mobility (lateral lumbar flexion from Bath Ankylosing Spondylitis Metrology Index \[BASMI\]); and acute phase reactant (high-sensitivity C-reactive protein).
Outcome measures
| Measure |
Adalimumab/Adalimumab
n=229 Participants
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
Placebo/Adalimumab
n=115 Participants
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
|---|---|---|
|
Number of Participants Meeting the ASAS5/6 Response Criteria
|
128 participants
|
14 participants
|
SECONDARY outcome
Timeframe: Week 24Population: ITT analysis set, missing data imputed by NRI
An ASAS5/6 responder had an improvement from Baseline of 20% or more in 5 of the following 6 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] scores); spinal mobility (lateral lumbar flexion from Bath Ankylosing Spondylitis Metrology Index \[BASMI\]); and acute phase reactant (high-sensitivity C-reactive protein).
Outcome measures
| Measure |
Adalimumab/Adalimumab
n=224 Participants
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
Placebo/Adalimumab
n=113 Participants
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
|---|---|---|
|
Number of Participants Meeting the ASAS5/6 Response Criteria
|
150 participants
|
69 participants
|
SECONDARY outcome
Timeframe: Week 12Population: ITT analysis set, missing data imputed by NRI
Participants were classified as having achieved ASAS partial remission if they had a value of less than 20 on a scale from 0 (normal/none) to 100 (most severe) in each of 4 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); and inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] scores).
Outcome measures
| Measure |
Adalimumab/Adalimumab
n=229 Participants
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
Placebo/Adalimumab
n=115 Participants
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
|---|---|---|
|
Number of Participants With ASAS Partial Remission
|
50 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Week 24Population: ITT analysis set, missing data imputed by NRI
Participants were classified as having achieved ASAS partial remission if they had a value of less than 20 on a scale from 0 (normal/none) to 100 (most severe) in each of 4 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); and inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] scores).
Outcome measures
| Measure |
Adalimumab/Adalimumab
n=224 Participants
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
Placebo/Adalimumab
n=113 Participants
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
|---|---|---|
|
Number of Participants With ASAS Partial Remission
|
85 participants
|
33 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT analysis set, missing data imputed by last observation carried forward (LOCF)
Participants assessed their disease activity during the preceding week using a 100 millimeter (mm) visual analog scale, with responses ranging from no activity (0) to severe activity (100).
Outcome measures
| Measure |
Adalimumab/Adalimumab
n=229 Participants
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
Placebo/Adalimumab
n=115 Participants
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
|---|---|---|
|
Change From Baseline in Patient Global Assessment of Disease Activity
|
-28.8 millimeters
Standard Deviation 24.16
|
-11.7 millimeters
Standard Deviation 21.77
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ITT analysis set, missing data imputed by last observation carried forward (LOCF)
Participants assessed their disease activity during the preceding week using a 100 millimeter (mm) visual analog scale, with responses ranging from no activity (0) to severe activity (100).
Outcome measures
| Measure |
Adalimumab/Adalimumab
n=224 Participants
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
Placebo/Adalimumab
n=113 Participants
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
|---|---|---|
|
Change From Baseline in Patient Global Assessment of Disease Activity
|
-37.8 millimeters
Standard Deviation 24.47
|
-35.5 millimeters
Standard Deviation 25.03
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT analysis set, LOCF
Participants assessed their total back pain within the preceding week using a total back pain 100 mm visual analog scale, with responses ranging from no pain (0) to most severe pain (100).
Outcome measures
| Measure |
Adalimumab/Adalimumab
n=229 Participants
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
Placebo/Adalimumab
n=115 Participants
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
|---|---|---|
|
Change From Baseline in Total Back Pain Score
|
-32.0 millimeters
Standard Deviation 23.55
|
-13.7 millimeters
Standard Deviation 22.88
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ITT analysis set, LOCF
Participants assessed their total back pain within the preceding week using a total back pain 100 mm visual analog scale, with responses ranging from no pain (0) to most severe pain (100).
Outcome measures
| Measure |
Adalimumab/Adalimumab
n=224 Participants
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
Placebo/Adalimumab
n=113 Participants
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
|---|---|---|
|
Change From Baseline in Total Back Pain Score
|
-42.1 millimeters
Standard Deviation 23.29
|
-37.8 millimeters
Standard Deviation 24.20
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT analysis set, LOCF
Participants assessed their ability to perform 10 selected activities (e.g., putting on socks or tights without help or aids, bending forward from the waist to pick up a pen from the floor without an aid) during the preceding week. Responses ranged from 0 (easy) to 100 (impossible). The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 100.
Outcome measures
| Measure |
Adalimumab/Adalimumab
n=229 Participants
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
Placebo/Adalimumab
n=115 Participants
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
|---|---|---|
|
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score
|
-17.5 units on a scale
Standard Deviation 20.18
|
-4.7 units on a scale
Standard Deviation 16.40
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ITT analysis set, LOCF
Participants assessed their ability to perform 10 selected activities (e.g., putting on socks or tights without help or aids, bending forward from the waist to pick up a pen from the floor without an aid) during the preceding week. Responses ranged from 0 (easy) to 100 (impossible). The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 100.
Outcome measures
| Measure |
Adalimumab/Adalimumab
n=224 Participants
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
Placebo/Adalimumab
n=113 Participants
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
|---|---|---|
|
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score
|
-23.2 units on a scale
Standard Deviation 21.03
|
-20.9 units on a scale
Standard Deviation 21.51
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT analysis set, LOCF
The Inflammation score is the mean of the 10-cm visual analog scale scores from the 2 morning stiffness-related BASDAI questions: "How would you describe the overall level of morning stiffness you have had from the time you wake up?", with response ranging from none to very severe; and "How long does your morning stiffness last from the time you wake up?", with response ranging from 0 hours to 2 or more hours.
Outcome measures
| Measure |
Adalimumab/Adalimumab
n=229 Participants
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
Placebo/Adalimumab
n=115 Participants
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
|---|---|---|
|
Change From Baseline in Inflammation Score
|
-2.9 centimeters
Standard Deviation 2.01
|
-1.5 centimeters
Standard Deviation 2.16
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ITT analysis set, LOCF
The Inflammation score is the mean of the 10-cm visual analog scale scores from the 2 morning stiffness-related BASDAI questions: "How would you describe the overall level of morning stiffness you have had from the time you wake up?", with response ranging from none to very severe; and "How long does your morning stiffness last from the time you wake up?", with response ranging from 0 hours to 2 or more hours.
Outcome measures
| Measure |
Adalimumab/Adalimumab
n=224 Participants
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
Placebo/Adalimumab
n=113 Participants
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
|---|---|---|
|
Change From Baseline in Inflammation Score
|
-3.6 centimeters
Standard Deviation 2.21
|
-3.6 centimeters
Standard Deviation 2.24
|
SECONDARY outcome
Timeframe: Week 12Population: ITT analysis set, missing data imputed by NRI
A BASDAI50 responder had at least a 50% improvement from Baseline in BASDAI score. In the BASDAI, participants use a 10-centimeter visual analog scale to answer 6 questions pertaining to symptoms experienced in the preceding week (e.g., How would you describe the overall level of fatigue/tiredness you have experienced? How long does your morning stiffness last from the time you wake up?) Responses range from "none" to "very severe" or from 0 hours to 2 or more hours for morning stiffness. The score is calculated as 0.2 (Q1 + Q2 + Q3 + Q4 + Q5/2 + Q6/2).
Outcome measures
| Measure |
Adalimumab/Adalimumab
n=229 Participants
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
Placebo/Adalimumab
n=115 Participants
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
|---|---|---|
|
Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria
|
114 participants
|
19 participants
|
SECONDARY outcome
Timeframe: Week 24Population: ITT analysis set, missing data imputed by NRI
A BASDAI50 responder had at least a 50% improvement from Baseline in BASDAI score. In the BASDAI, participants use a 10-centimeter visual analog scale to answer 6 questions pertaining to symptoms experienced in the preceding week (e.g., How would you describe the overall level of fatigue/tiredness you have experienced? How long does your morning stiffness last from the time you wake up?) Responses range from "none" to "very severe" or from 0 hours to 2 or more hours for morning stiffness. The score is calculated as 0.2 (Q1 + Q2 + Q3 + Q4 + Q5/2 + Q6/2).
Outcome measures
| Measure |
Adalimumab/Adalimumab
n=224 Participants
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
Placebo/Adalimumab
n=113 Participants
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
|---|---|---|
|
Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria
|
156 participants
|
71 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT analysis set, LOCF
Elevation of hs-CRP is a nonspecific marker of inflammation. Values above 5 milligrams/liter (mg/L) were considered abnormally high. Decrease in level of hs-CRP indicates reduction in inflammation.
Outcome measures
| Measure |
Adalimumab/Adalimumab
n=229 Participants
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
Placebo/Adalimumab
n=115 Participants
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
|---|---|---|
|
Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)
|
-17.8 milligrams/liter
Standard Deviation 23.76
|
-4.2 milligrams/liter
Standard Deviation 21.23
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ITT analysis set, LOCF
Elevation of hs-CRP is a nonspecific marker of inflammation. Values above 5 milligrams/liter (mg/L) were considered abnormally high. Decrease in level of hs-CRP indicates reduction in inflammation.
Outcome measures
| Measure |
Adalimumab/Adalimumab
n=224 Participants
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
Placebo/Adalimumab
n=113 Participants
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
|---|---|---|
|
Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)
|
-18.2 milligrams/liter
Standard Deviation 24.27
|
-20.1 milligrams/liter
Standard Deviation 30.63
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT analysis set, observed cases
The SF-36 questionnaire, version 2, consists of 36 general health questions with 2 components, physical and mental. For each component, a transformed summary score is calculated using 8 sub-domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100. Higher scores indicate a better health state.
Outcome measures
| Measure |
Adalimumab/Adalimumab
n=226 Participants
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
Placebo/Adalimumab
n=113 Participants
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
|---|---|---|
|
Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score
|
6.6 units on a scale
Standard Deviation 6.43
|
4.0 units on a scale
Standard Deviation 6.31
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ITT analysis set, observed cases
The SF-36 questionnaire, version 2, consists of 36 general health questions with 2 components, physical and mental. For each component, a transformed summary score is calculated using 8 sub-domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100. Higher scores indicate a better health state.
Outcome measures
| Measure |
Adalimumab/Adalimumab
n=222 Participants
Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
Placebo/Adalimumab
n=110 Participants
Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
|
|---|---|---|
|
Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score
|
8.6 units on a scale
Standard Deviation 7.44
|
9.2 units on a scale
Standard Deviation 7.25
|
Adverse Events
Adalimumab (Period 1)
Placebo (Period 1)
Adalimumab/Adalimumab (Period 2)
Placebo/Adalimumab (Period 2)
Serious adverse events
| Measure |
Adalimumab (Period 1)
n=229 participants at risk
Blinded adalimumab from Week 0 to Week 10
|
Placebo (Period 1)
n=115 participants at risk
Blinded placebo from Week 0 to Week 10
|
Adalimumab/Adalimumab (Period 2)
n=224 participants at risk
Open-label adalimumab from Week 12 to Week 22 in participants previously on blinded adalimumab from Week 0 to Week 10
|
Placebo/Adalimumab (Period 2)
n=113 participants at risk
Open-label adalimumab from Week 12 to Week 22 in participants previously on blinded placebo from Week 0 to Week 10
|
|---|---|---|---|---|
|
Infections and infestations
Hepatitis viral
|
0.00%
0/229 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/115 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/224 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.88%
1/113 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.44%
1/229 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/115 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/224 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/113 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
|
Infections and infestations
Peritoneal tuberculosis
|
0.00%
0/229 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/115 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.45%
1/224 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/113 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/229 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/115 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.45%
1/224 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/113 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
|
Infections and infestations
Tuberculosis pleurisy
|
0.00%
0/229 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/115 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.45%
1/224 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/113 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/229 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/115 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.45%
1/224 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/113 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/229 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/115 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.45%
1/224 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/113 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/229 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/115 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.45%
1/224 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/113 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.00%
0/229 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.87%
1/115 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/224 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/113 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal papilloma of breast
|
0.00%
0/229 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.87%
1/115 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/224 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/113 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/229 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/115 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.45%
1/224 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/113 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
Other adverse events
| Measure |
Adalimumab (Period 1)
n=229 participants at risk
Blinded adalimumab from Week 0 to Week 10
|
Placebo (Period 1)
n=115 participants at risk
Blinded placebo from Week 0 to Week 10
|
Adalimumab/Adalimumab (Period 2)
n=224 participants at risk
Open-label adalimumab from Week 12 to Week 22 in participants previously on blinded adalimumab from Week 0 to Week 10
|
Placebo/Adalimumab (Period 2)
n=113 participants at risk
Open-label adalimumab from Week 12 to Week 22 in participants previously on blinded placebo from Week 0 to Week 10
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.3%
3/229 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/115 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.45%
1/224 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/113 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
1.3%
3/229 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/115 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/224 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/113 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
|
General disorders
Injection site erythema
|
1.7%
4/229 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/115 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/224 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.88%
1/113 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
|
General disorders
Injection site swelling
|
0.44%
1/229 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/115 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/224 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
1.8%
2/113 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
1.7%
4/229 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
1.7%
2/115 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.45%
1/224 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/113 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.7%
13/229 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
7.8%
9/115 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
5.8%
13/224 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
7.1%
8/113 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
|
Investigations
Alanine aminotransferase increased
|
11.4%
26/229 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
1.7%
2/115 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
4.9%
11/224 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
11.5%
13/113 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
|
Investigations
Aspartate aminotransferase increased
|
8.7%
20/229 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.87%
1/115 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
2.7%
6/224 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
8.0%
9/113 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
|
Investigations
Blood alkaline phosphatase increased
|
1.3%
3/229 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/115 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/224 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
1.8%
2/113 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/229 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/115 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
1.8%
4/224 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/113 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
|
Investigations
Blood triglycerides increased
|
1.3%
3/229 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.87%
1/115 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.89%
2/224 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
1.8%
2/113 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
|
Investigations
Platelet count decreased
|
0.87%
2/229 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/115 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
1.8%
4/224 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/113 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
|
Investigations
White blood cell count decreased
|
2.6%
6/229 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
1.7%
2/115 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.89%
2/224 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.88%
1/113 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.3%
3/229 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.87%
1/115 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/224 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/113 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
1.3%
3/229 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.00%
0/115 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.45%
1/224 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
0.88%
1/113 • All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected, for a maximum reporting period of 32 weeks.
|
Additional Information
Global Medical Services
Abbott
Results disclosure agreements
- Principal investigator is a sponsor employee Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER