Trial Outcomes & Findings for Moderate Rheumatoid Arthritis (RA) With Etanercept (Enbrel) (NCT NCT01313208)
NCT ID: NCT01313208
Last Updated: 2017-02-09
Results Overview
Low disease activity is defined by a disease activity score (28 joint) calculated using the C-reactive protein formula (DAS28-CRP) of less than 3.2. The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • C-Reactive Protein (CRP) level • Patient's global assessment of disease activity measured on a likert scale from 0 (no activity at all) to 10 (worst activity). The DAS28 score ranges from zero up to approximately ten. DAS28 scores above 5.1 indicate high disease activity.
COMPLETED
PHASE4
210 participants
Week 12
2017-02-09
Participant Flow
First patient enrolled on 31 March 2011; Last patient enrolled 29 November 2012
Participant milestones
| Measure |
Placebo
Participants received placebo subcutaneous injections once a week for 12 weeks and then open-label etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks. All participants continued their disease modifying anti-rheumatic drug (DMARD) treatment throughout the 24-week study period.
|
Etanercept
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then open-label etanercept 50 mg subcutaneous injection for the next 12 weeks.
All participants continued their DMARD treatment throughout the 24-week study period.
|
|---|---|---|
|
Double-blind Phase (Weeks 1 - 12)
STARTED
|
104
|
106
|
|
Double-blind Phase (Weeks 1 - 12)
COMPLETED
|
98
|
101
|
|
Double-blind Phase (Weeks 1 - 12)
NOT COMPLETED
|
6
|
5
|
|
Open-label Phase (Weeks 13 - 24)
STARTED
|
98
|
101
|
|
Open-label Phase (Weeks 13 - 24)
COMPLETED
|
92
|
98
|
|
Open-label Phase (Weeks 13 - 24)
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo subcutaneous injections once a week for 12 weeks and then open-label etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks. All participants continued their disease modifying anti-rheumatic drug (DMARD) treatment throughout the 24-week study period.
|
Etanercept
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then open-label etanercept 50 mg subcutaneous injection for the next 12 weeks.
All participants continued their DMARD treatment throughout the 24-week study period.
|
|---|---|---|
|
Double-blind Phase (Weeks 1 - 12)
Withdrawal by Subject
|
3
|
2
|
|
Double-blind Phase (Weeks 1 - 12)
Adverse Event
|
1
|
2
|
|
Double-blind Phase (Weeks 1 - 12)
Ineligibility determined
|
0
|
1
|
|
Double-blind Phase (Weeks 1 - 12)
Lost to Follow-up
|
1
|
0
|
|
Double-blind Phase (Weeks 1 - 12)
Noncompliance
|
1
|
0
|
|
Open-label Phase (Weeks 13 - 24)
Withdrawal by Subject
|
3
|
1
|
|
Open-label Phase (Weeks 13 - 24)
Noncompliance
|
0
|
2
|
|
Open-label Phase (Weeks 13 - 24)
Adverse Event
|
1
|
0
|
|
Open-label Phase (Weeks 13 - 24)
Other
|
2
|
0
|
Baseline Characteristics
Moderate Rheumatoid Arthritis (RA) With Etanercept (Enbrel)
Baseline characteristics by cohort
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks and then open-label etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks. All participants continued their disease modifying anti-rheumatic drug (DMARD) treatment throughout the 24-week study period.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then open-label etanercept 50 mg subcutaneous injection for the next 12 weeks.
All participants continued their DMARD treatment throughout the 24-week study period.
|
Total
n=210 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.5 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
56.5 years
STANDARD_DEVIATION 12.1 • n=7 Participants
|
56.0 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed race
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
90 participants
n=5 Participants
|
91 participants
n=7 Participants
|
181 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Duration of Rheumatoid Arthritis
|
7.41 years
STANDARD_DEVIATION 8.11 • n=5 Participants
|
8.26 years
STANDARD_DEVIATION 11.16 • n=7 Participants
|
7.84 years
STANDARD_DEVIATION 9.76 • n=5 Participants
|
|
Baseline methotrexate use
Yes
|
93 participants
n=5 Participants
|
94 participants
n=7 Participants
|
187 participants
n=5 Participants
|
|
Baseline methotrexate use
No
|
11 participants
n=5 Participants
|
12 participants
n=7 Participants
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Primary analysis set (all randomized participants); last observation carried forward (LOCF) imputation was used.
Low disease activity is defined by a disease activity score (28 joint) calculated using the C-reactive protein formula (DAS28-CRP) of less than 3.2. The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • C-Reactive Protein (CRP) level • Patient's global assessment of disease activity measured on a likert scale from 0 (no activity at all) to 10 (worst activity). The DAS28 score ranges from zero up to approximately ten. DAS28 scores above 5.1 indicate high disease activity.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving DAS28 Low Disease Activity at Week 12
|
21.2 percentage of participants
|
33.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: Primary analysis set; LOCF was used
Remission is defined by a DAS28 score less than 2.6. The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: * The number of swollen and tender joints assessed using the 28-joint count; * C-reactive protein (CRP) * Patient's global assessment of disease activity measured on a likert scale from 0 (no activity at all) to 10 (worst activity). The DAS28 score ranges from zero to ten. DAS28 above 5.1 indicates high disease activity.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving DAS28 Remission at Week 12
|
11.5 percentage of participants
|
18.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 16, 20 and 24Population: Primary analysis set; LOCF was used. "N" indicates the number of participants included in the analysis at each time point.
Low disease activity is defined by a disease activity score (28 joint) calculated using the C-reactive protein formula (DAS28-CRP) of less than 3.2. The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: * The number of swollen and tender joints assessed using the 28-joint count; * C-Reactive Protein (CRP) level * Patient's global assessment of disease activity measured on a likert scale from 0 (no activity at all) to 10 (worst activity). The DAS28 score ranges from zero up to approximately ten. DAS28 scores above 5.1 indicate high disease activity.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving DAS28 Low Disease Activity at All Other Timepoints
Baseline (N=104, 104)
|
2.9 percentage of participants
|
1.0 percentage of participants
|
|
Percentage of Participants Achieving DAS28 Low Disease Activity at All Other Timepoints
Week 2 (N=99, 105)
|
10.1 percentage of participants
|
21.0 percentage of participants
|
|
Percentage of Participants Achieving DAS28 Low Disease Activity at All Other Timepoints
Week 4 (N=104, 106)
|
15.4 percentage of participants
|
24.5 percentage of participants
|
|
Percentage of Participants Achieving DAS28 Low Disease Activity at All Other Timepoints
Week 8 (N=104, 106)
|
16.3 percentage of participants
|
34.0 percentage of participants
|
|
Percentage of Participants Achieving DAS28 Low Disease Activity at All Other Timepoints
Week 16 (N=104, 106)
|
37.5 percentage of participants
|
40.6 percentage of participants
|
|
Percentage of Participants Achieving DAS28 Low Disease Activity at All Other Timepoints
Week 20 (N=104, 106)
|
46.2 percentage of participants
|
45.3 percentage of participants
|
|
Percentage of Participants Achieving DAS28 Low Disease Activity at All Other Timepoints
Week 24 (N=104, 106)
|
43.3 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 16, 20 and 24Population: Primary analysis set; LOCF was used. "N" indicates the number of participants included in the analyses at each time point.
Remission is defined by a DAS28 score less than 2.6. The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: * The number of swollen and tender joints assessed using the 28-joint count; * C-reactive protein (CRP) * Patient's global assessment of disease activity measured on a likert scale from 0 (no activity at all) to 10 (worst activity). The DAS28 score ranges from zero to ten. A DAS28 above 5.1 indicates high disease activity.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving DAS28 Remission at All Other Timepoints
Baseline (N=104, 104)
|
1.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Achieving DAS28 Remission at All Other Timepoints
Week 2 (N=99, 105)
|
5.1 percentage of participants
|
8.6 percentage of participants
|
|
Percentage of Participants Achieving DAS28 Remission at All Other Timepoints
Week 4 (N=104, 106)
|
6.7 percentage of participants
|
11.3 percentage of participants
|
|
Percentage of Participants Achieving DAS28 Remission at All Other Timepoints
Week 8 (N=104, 106)
|
5.8 percentage of participants
|
25.5 percentage of participants
|
|
Percentage of Participants Achieving DAS28 Remission at All Other Timepoints
Week 16 (N=104, 106)
|
22.1 percentage of participants
|
25.5 percentage of participants
|
|
Percentage of Participants Achieving DAS28 Remission at All Other Timepoints
Week 20 (N=104, 106)
|
29.8 percentage of participants
|
26.4 percentage of participants
|
|
Percentage of Participants Achieving DAS28 Remission at All Other Timepoints
Week 24 (N=104, 106)
|
32.7 percentage of participants
|
31.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24Population: Primary analysis set; LOCF was used. "N" indicates the number of participants with available data at each time point.
A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); ◦ Patient's global assessment of disease activity (measured on a likert scale from 0 to 10); ◦ Physician's global assessment of disease activity (measured on a likert scale from 0 to 10); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]); ◦ C-Reactive Protein level.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Each Timepoint
Week 2 (N=101, 105)
|
14.9 percentage of participants
|
28.6 percentage of participants
|
|
Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Each Timepoint
Week 4 (N=104, 106)
|
19.2 percentage of participants
|
36.8 percentage of participants
|
|
Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Each Timepoint
Week 8 (N=104, 106)
|
23.1 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Each Timepoint
Week 12 (N=104, 106)
|
28.8 percentage of participants
|
40.6 percentage of participants
|
|
Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Each Timepoint
Week 16 (N=104, 106)
|
47.1 percentage of participants
|
49.1 percentage of participants
|
|
Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Each Timepoint
Week 20 (N=104, 106)
|
54.8 percentage of participants
|
51.9 percentage of participants
|
|
Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Each Timepoint
Week 24 N=104, 106)
|
46.2 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24Population: Primary analysis set; LOCF was used. "N" indicates the number of participants with available data at each time point.
A participant was a responder if the following 3 criteria for improvement from Baseline were met: * ≥ 50% improvement in tender joint count; * ≥ 50% improvement in swollen joint count; and * ≥ 50% improvement in at least 3 of the 5 following parameters: * Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a likert scale from 0 to 10); * Physician's global assessment of disease activity (measured on a likert scale from 0 to 10); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]); * C-reactive protein (CRP) level.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Each Timepoint
Week 2 (N=101, 106)
|
3.0 percentage of participants
|
5.7 percentage of participants
|
|
Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Each Timepoint
Week 4 (N=104, 106)
|
4.8 percentage of participants
|
13.2 percentage of participants
|
|
Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Each Timepoint
Week 8 (N=104, 106)
|
4.8 percentage of participants
|
19.8 percentage of participants
|
|
Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Each Timepoint
Week 12, (N=104, 106)
|
12.5 percentage of participants
|
20.8 percentage of participants
|
|
Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Each Timepoint
Week 16 (N=104, 106)
|
22.1 percentage of participants
|
30.2 percentage of participants
|
|
Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Each Timepoint
Week 20 (N=104, 106)
|
28.8 percentage of participants
|
29.2 percentage of participants
|
|
Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Each Timepoint
Week 24 (N=104, 106)
|
28.8 percentage of participants
|
33.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24Population: Primary analysis set; LOCF was used. "N" indicates the number of participants with available data at each time point.
A participant was a responder if the following 3 criteria for improvement from Baseline were met: * ≥ 70% improvement in tender joint count; * ≥ 70% improvement in swollen joint count; and * ≥ 70% improvement in at least 3 of the 5 following parameters: * Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a likert scale from 0 to 10); * Physician's global assessment of disease activity (measured on a likert scale from 0 to 10); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]); * C-reactive protein (CRP) level.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Each Timepoint
Week 2 (N=101, 106)
|
0.0 percentage of participants
|
1.9 percentage of participants
|
|
Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Each Timepoint
Week 4 (N=104, 106)
|
0.0 percentage of participants
|
1.9 percentage of participants
|
|
Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Each Timepoint
Week 8 (N=104, 106)
|
0.0 percentage of participants
|
5.7 percentage of participants
|
|
Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Each Timepoint
Week 12, (N=104, 106)
|
1.0 percentage of participants
|
5.7 percentage of participants
|
|
Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Each Timepoint
Week 16 (N=104, 106)
|
9.6 percentage of participants
|
8.5 percentage of participants
|
|
Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Each Timepoint
Week 20 (N=104, 106)
|
10.6 percentage of participants
|
17.0 percentage of participants
|
|
Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Each Timepoint
Week 24 (N=104, 106)
|
12.5 percentage of participants
|
16.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12, and 24Population: Primary analysis set; LOCF was used. "N" indicates the number of participants included in the analyses at each time point.
The Multi-Dimensional Health Assessment Questionnaire (MDHAQ) is adapted from the standard HAQ and is used for the computation of the Routine Assessment of Patient Index Data 3 (RAPID3). The RAPID 3 includes the 3 Core Data Set measures of physical function, pain, and patient global estimate. The score for physical function ranges from 0 to 10 and is calculated by adding the ten activities of daily living, each scored from 0 to 3 by the patient (0="without any difficulty", 1="with some difficulty", 2="with much difficulty", and 3="unable to do") and dividing the total raw score by 3. Pain and global estimate of health are measured on a likert scale from 0 to 10, both scored 0 (best) to 10 (worst). The three 0-10 scores for physical function, pain, and global assesment of health are added together for a composite score of 0 to 30. The RAPID3 composite score includes 4 categories: High Severity \> 12, Moderate Severity = 6.1 - 12, Low severity = 3.1 - 6, and Remission ≤ 3.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With RAPID3 Remission or Low Severity at Each Time Point
Baseline (N=96, 99)
|
9.4 percentage of participants
|
9.1 percentage of participants
|
|
Percentage of Participants With RAPID3 Remission or Low Severity at Each Time Point
Week 4 (N=95, 99)
|
21.1 percentage of participants
|
30.3 percentage of participants
|
|
Percentage of Participants With RAPID3 Remission or Low Severity at Each Time Point
Week 12 (N=102, 103)
|
21.6 percentage of participants
|
39.8 percentage of participants
|
|
Percentage of Participants With RAPID3 Remission or Low Severity at Each Time Point
Week 24 (N=103, 103)
|
41.7 percentage of participants
|
46.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24Population: Primary analysis set; LOCF was used. "N" indicates the number of participants included in the analyses at each time point.
Count remission is achieved when a participant satisfies all of the following at any given time point: - 68 tender joint count ≤ 1, - 66 swollen joint count ≤ 1, - C-reactive protein (CRP) (in mg/dL) ≤1, and - patient global assessment of disease activity ≤ 1 (measured on a likert scale from 0 to 10 ranging from "no activity at all" to "worst activity imaginable").
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving Count Remission at Each Time Point
Baseline (N=104, 106)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Achieving Count Remission at Each Time Point
Week 2 (N=101, 106)
|
1.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Achieving Count Remission at Each Time Point
Week 4 (N=104, 106)
|
0.0 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Participants Achieving Count Remission at Each Time Point
Week 8 (N=104, 106)
|
0.0 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Participants Achieving Count Remission at Each Time Point
Week 12 (N=104, 106)
|
1.9 percentage of participants
|
4.7 percentage of participants
|
|
Percentage of Participants Achieving Count Remission at Each Time Point
Week 16 (N=104, 106)
|
3.8 percentage of participants
|
5.7 percentage of participants
|
|
Percentage of Participants Achieving Count Remission at Each Time Point
Week 20 (N=104, 106)
|
5.8 percentage of participants
|
10.4 percentage of participants
|
|
Percentage of Participants Achieving Count Remission at Each Time Point
Week 24 (N=104, 106)
|
7.7 percentage of participants
|
10.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24Population: Primary analysis set; LOCF was used. "N" indicates the number of participants included in the analyses at each time point.
The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: * 28 tender joint count (TJC), * 28 swollen joint count (SJC), * Patient's Global Assessment of Disease Activity measured on a likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest; * Physician's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest. The CDAI score ranges from 0-76 where lower scores indicate less disease activity. CDAI remission is defined as a score ≤ 2.8.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving CDAI Remission at Each Time Point
Baseline (N=101, 101)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Achieving CDAI Remission at Each Time Point
Week 2 (N=99, 106)
|
1.0 percentage of participants
|
1.9 percentage of participants
|
|
Percentage of Participants Achieving CDAI Remission at Each Time Point
Week 4 (N=104, 106)
|
0.0 percentage of participants
|
0.9 percentage of participants
|
|
Percentage of Participants Achieving CDAI Remission at Each Time Point
Week 8 (N=104, 106)
|
0.0 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Participants Achieving CDAI Remission at Each Time Point
Week 12 (N=104, 106)
|
1.0 percentage of participants
|
3.8 percentage of participants
|
|
Percentage of Participants Achieving CDAI Remission at Each Time Point
Week 16 (N=104, 106)
|
3.8 percentage of participants
|
7.5 percentage of participants
|
|
Percentage of Participants Achieving CDAI Remission at Each Time Point
Week 20 (N=104, 106)
|
6.7 percentage of participants
|
10.4 percentage of participants
|
|
Percentage of Participants Achieving CDAI Remission at Each Time Point
Week 24 (N=104, 106)
|
3.8 percentage of participants
|
8.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24Population: Primary analysis set; LOCF was used. "N" indicates the number of participants included in the analyses at each time point.
The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: * 28 tender joint count (TJC), * 28 swollen joint count (SJC), * Patient's Global Assessment of Disease Activity measured on a Likert scale form 0 to 10, where 0 = lowest disease activity and 10 = highest; * Physician's Global Assessment of Disease Activity -measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest. The CDAI score ranges from 0 to 76 where lower scores indicate less disease activity. CDAI low disease activity is defined as a score ≤ 10.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving CDAI Low Disease Activity at Each Time Point
Baseline (N=101, 101)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Achieving CDAI Low Disease Activity at Each Time Point
Week 2 (N=99, 106)
|
9.1 percentage of participants
|
12.3 percentage of participants
|
|
Percentage of Participants Achieving CDAI Low Disease Activity at Each Time Point
Week 4 (N=104, 106)
|
16.3 percentage of participants
|
18.9 percentage of participants
|
|
Percentage of Participants Achieving CDAI Low Disease Activity at Each Time Point
Week 8 (N=104, 106)
|
15.4 percentage of participants
|
29.2 percentage of participants
|
|
Percentage of Participants Achieving CDAI Low Disease Activity at Each Time Point
Week 12 (N=104, 106)
|
21.2 percentage of participants
|
25.5 percentage of participants
|
|
Percentage of Participants Achieving CDAI Low Disease Activity at Each Time Point
Week 16 (N=104, 106)
|
32.7 percentage of participants
|
35.8 percentage of participants
|
|
Percentage of Participants Achieving CDAI Low Disease Activity at Each Time Point
Week 20 (N=104, 106)
|
42.3 percentage of participants
|
38.7 percentage of participants
|
|
Percentage of Participants Achieving CDAI Low Disease Activity at Each Time Point
Week 24 (N=104, 106)
|
41.3 percentage of participants
|
46.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24Population: Primary analysis set; LOCF was used. "N" indicates the number of participants included in the analyses at each time point.
The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: * 28 tender joint count (TJC), * 28 swollen joint count (SJC), * Patient's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10 where 0 = lowest disease activity and 10 = highest; * Physician's Global Assessment of Disease Activity (measured on a Likert scale from 0 to 10 where 0 = lowest disease activity and 10 = highest). The CDAI score ranges from 0 to 76 where lower scores indicate less disease activity.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Clinical Disease Activity Index (CDAI) Score at Each Time Point
Baseline (N=101, 101)
|
30.18 scores on a scale
Standard Deviation 9.30
|
29.79 scores on a scale
Standard Deviation 9.08
|
|
Clinical Disease Activity Index (CDAI) Score at Each Time Point
Week 2 (N=99, 106)
|
26.67 scores on a scale
Standard Deviation 12.89
|
24.32 scores on a scale
Standard Deviation 12.94
|
|
Clinical Disease Activity Index (CDAI) Score at Each Time Point
Week 4 (N=104, 106)
|
24.81 scores on a scale
Standard Deviation 12.76
|
21.56 scores on a scale
Standard Deviation 12.82
|
|
Clinical Disease Activity Index (CDAI) Score at Each Time Point
Week 8 (N=104, 106)
|
22.83 scores on a scale
Standard Deviation 12.25
|
20.22 scores on a scale
Standard Deviation 13.96
|
|
Clinical Disease Activity Index (CDAI) Score at Each Time Point
Week 12 (N=104, 106)
|
22.79 scores on a scale
Standard Deviation 14.07
|
20.68 scores on a scale
Standard Deviation 14.90
|
|
Clinical Disease Activity Index (CDAI) Score at Each Time Point
Week 16 (N=104, 106)
|
18.03 scores on a scale
Standard Deviation 12.34
|
18.28 scores on a scale
Standard Deviation 15.16
|
|
Clinical Disease Activity Index (CDAI) Score at Each Time Point
Week 20 (N=104, 106)
|
15.13 scores on a scale
Standard Deviation 10.80
|
17.47 scores on a scale
Standard Deviation 14.90
|
|
Clinical Disease Activity Index (CDAI) Score at Each Time Point
Week 24 (N=104, 106)
|
16.33 scores on a scale
Standard Deviation 11.85
|
16.86 scores on a scale
Standard Deviation 14.74
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24Population: Primary analysis set; LOCF was used. "N" indicates the number of participants included in the analyses at each time point.
The simplified disease activity index (SDAI) is a composite measure that sums the total number of: * 28 tender joint counts, * 28 swollen joint counts, * Patient's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10 where 0= lowest disease activity and 10 = highest; * Physician's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest, and * C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to approximately 86 where lower scores indicate less disease activity. SDAI remission is defined as a score ≤ 3.3.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving SDAI Remission at Each Time Point
Baseline (N=101, 101)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Achieving SDAI Remission at Each Time Point
Week 2 (N=97, 105)
|
1.0 percentage of participants
|
1.0 percentage of participants
|
|
Percentage of Participants Achieving SDAI Remission at Each Time Point
Week 4 (N=104, 106)
|
1.0 percentage of participants
|
0.9 percentage of participants
|
|
Percentage of Participants Achieving SDAI Remission at Each Time Point
Week 8 (N=104, 106)
|
0.0 percentage of participants
|
5.7 percentage of participants
|
|
Percentage of Participants Achieving SDAI Remission at Each Time Point
Week 12 (N=104, 106)
|
1.9 percentage of participants
|
5.7 percentage of participants
|
|
Percentage of Participants Achieving SDAI Remission at Each Time Point
Week 16 (N=104, 106)
|
4.8 percentage of participants
|
8.5 percentage of participants
|
|
Percentage of Participants Achieving SDAI Remission at Each Time Point
Week 20 (N=104, 106)
|
8.7 percentage of participants
|
11.3 percentage of participants
|
|
Percentage of Participants Achieving SDAI Remission at Each Time Point
Week 24 (N=104, 106)
|
6.7 percentage of participants
|
10.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24Population: Primary analysis set; LOCF was used. "N" indicates the number of participants included in the analyses at each time point.
The simplified disease activity index (SDAI) is a composite measure that sums the total number of: - 28 tender joint counts, - 28 swollen joint counts, - Patient's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10 where 0 = lowest disease activity and 10 = highest; - Physician's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10 where 0 = lowest disease activity and 10 = highest, and - C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to approximately 86 where lower scores indicate less disease activity. SDAI low disease activity is defined as a score ≤ 11.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving SDAI Low Disease Activity at Each Time Point
Week 2 (N=97, 105)
|
8.2 percentage of participants
|
12.4 percentage of participants
|
|
Percentage of Participants Achieving SDAI Low Disease Activity at Each Time Point
Week 4 (N=104, 106)
|
13.5 percentage of participants
|
18.9 percentage of participants
|
|
Percentage of Participants Achieving SDAI Low Disease Activity at Each Time Point
Week 8 (N=104, 106)
|
14.4 percentage of participants
|
30.2 percentage of participants
|
|
Percentage of Participants Achieving SDAI Low Disease Activity at Each Time Point
Week 12 (N=104, 106)
|
21.2 percentage of participants
|
23.6 percentage of participants
|
|
Percentage of Participants Achieving SDAI Low Disease Activity at Each Time Point
Week 16 (N=104, 106)
|
32.7 percentage of participants
|
35.8 percentage of participants
|
|
Percentage of Participants Achieving SDAI Low Disease Activity at Each Time Point
Week 20 (N=104, 106)
|
42.3 percentage of participants
|
38.7 percentage of participants
|
|
Percentage of Participants Achieving SDAI Low Disease Activity at Each Time Point
Week 24 (N=104, 106)
|
39.4 percentage of participants
|
45.3 percentage of participants
|
|
Percentage of Participants Achieving SDAI Low Disease Activity at Each Time Point
Baseline (N=101, 101)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24Population: Primary analysis set; LOCF was used. "N" indicates the number of participants included in the analyses at each time point.
The simplified disease activity index (SDAI) is a composite measure that sums the total number of: * 28 tender joint counts, * 28 swollen joint counts, * Patient's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest; * Physician's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest, and * C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to approximately 86 where lower scores indicate less disease activity.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Simplified Clinical Disease Activity Index (SDAI) Score at Each Time Point
Baseline (N=101, 101)
|
31.00 scores on a scale
Standard Deviation 9.49
|
30.56 scores on a scale
Standard Deviation 9.01
|
|
Simplified Clinical Disease Activity Index (SDAI) Score at Each Time Point
Week 2 (N=97, 105)
|
27.83 scores on a scale
Standard Deviation 12.89
|
24.77 scores on a scale
Standard Deviation 12.96
|
|
Simplified Clinical Disease Activity Index (SDAI) Score at Each Time Point
Week 4 (N=104, 106)
|
25.81 scores on a scale
Standard Deviation 12.89
|
22.00 scores on a scale
Standard Deviation 12.86
|
|
Simplified Clinical Disease Activity Index (SDAI) Score at Each Time Point
Week 8 (N=104, 106)
|
23.64 scores on a scale
Standard Deviation 12.32
|
20.51 scores on a scale
Standard Deviation 14.08
|
|
Simplified Clinical Disease Activity Index (SDAI) Score at Each Time Point
Week 12 (N=104, 106)
|
23.52 scores on a scale
Standard Deviation 14.02
|
21.09 scores on a scale
Standard Deviation 15.05
|
|
Simplified Clinical Disease Activity Index (SDAI) Score at Each Time Point
Week 16 (N=104, 106)
|
18.55 scores on a scale
Standard Deviation 12.43
|
18.68 scores on a scale
Standard Deviation 15.25
|
|
Simplified Clinical Disease Activity Index (SDAI) Score at Each Time Point
Week 20 (N=104, 106)
|
15.61 scores on a scale
Standard Deviation 10.77
|
17.87 scores on a scale
Standard Deviation 14.98
|
|
Simplified Clinical Disease Activity Index (SDAI) Score at Each Time Point
Week 24 (N=104, 106)
|
16.93 scores on a scale
Standard Deviation 11.90
|
17.30 scores on a scale
Standard Deviation 14.85
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24Population: Primary analysis set; LOCF was used. "N" indicates the number of participants included in the analyses at each time point.
Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Tender 28-Joint Count (TJC28) at Each Time Point
Baseline (N=104, 106)
|
11.1 tender joints
Standard Deviation 5.5
|
10.6 tender joints
Standard Deviation 5.1
|
|
Tender 28-Joint Count (TJC28) at Each Time Point
Week 2 (N=101, 106)
|
10.1 tender joints
Standard Deviation 6.7
|
9.6 tender joints
Standard Deviation 7.6
|
|
Tender 28-Joint Count (TJC28) at Each Time Point
Week 4 (N=104, 106)
|
9.4 tender joints
Standard Deviation 6.9
|
8.4 tender joints
Standard Deviation 6.9
|
|
Tender 28-Joint Count (TJC28) at Each Time Point
Week 8 (N=104, 106)
|
8.0 tender joints
Standard Deviation 6.2
|
7.7 tender joints
Standard Deviation 7.7
|
|
Tender 28-Joint Count (TJC28) at Each Time Point
Week 12 (N=104, 106)
|
8.8 tender joints
Standard Deviation 7.0
|
8.1 tender joints
Standard Deviation 8.0
|
|
Tender 28-Joint Count (TJC28) at Each Time Point
Week 16 (N=104, 106)
|
6.6 tender joints
Standard Deviation 6.3
|
6.9 tender joints
Standard Deviation 7.9
|
|
Tender 28-Joint Count (TJC28) at Each Time Point
Week 20 (N=104, 106)
|
5.1 tender joints
Standard Deviation 5.3
|
6.5 tender joints
Standard Deviation 7.9
|
|
Tender 28-Joint Count (TJC28) at Each Time Point
Week 24 (N=104, 106)
|
6.0 tender joints
Standard Deviation 6.4
|
6.5 tender joints
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24Population: Primary analysis set; LOCF was used. "N" indicates the number of participants included in the analyses at each time point.
Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Swollen 28-Joint Count (SJC28) at Each Time Point
Baseline (N=104, 106)
|
8.5 swollen joints
Standard Deviation 4.4
|
8.4 swollen joints
Standard Deviation 5.0
|
|
Swollen 28-Joint Count (SJC28) at Each Time Point
Week 2 (N=101, 106)
|
6.9 swollen joints
Standard Deviation 5.4
|
6.7 swollen joints
Standard Deviation 4.5
|
|
Swollen 28-Joint Count (SJC28) at Each Time Point
Week 4 (N=104, 106)
|
6.7 swollen joints
Standard Deviation 5.3
|
5.4 swollen joints
Standard Deviation 4.6
|
|
Swollen 28-Joint Count (SJC28) at Each Time Point
Week 8 (N=104, 106)
|
6.2 swollen joints
Standard Deviation 4.9
|
5.4 swollen joints
Standard Deviation 4.9
|
|
Swollen 28-Joint Count (SJC28) at Each Time Point
Week 12 (N=104, 106)
|
5.7 swollen joints
Standard Deviation 5.4
|
5.5 swollen joints
Standard Deviation 4.9
|
|
Swollen 28-Joint Count (SJC28) at Each Time Point
Week 16 (N=104, 106)
|
5.0 swollen joints
Standard Deviation 4.5
|
5.2 swollen joints
Standard Deviation 5.4
|
|
Swollen 28-Joint Count (SJC28) at Each Time Point
Week 20 (N=104, 106)
|
4.4 swollen joints
Standard Deviation 4.7
|
4.8 swollen joints
Standard Deviation 4.9
|
|
Swollen 28-Joint Count (SJC28) at Each Time Point
Week 24 (N=104, 106)
|
4.6 swollen joints
Standard Deviation 4.7
|
4.6 swollen joints
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24Population: Primary analysis set; LOCF was used. "N" indicates the number of participants included in the analyses at each time point.
The severity of the participant's joint pain was assessed using a visual analog scale (VAS). The participant was asked to draw a mark through a 100 mm horizontal line to indicate how much pain they were experiencing "today", from '0' (no pain at all) on the left end of the line to 100 (worst pain imaginable) on the right end of the line.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Patient Global Assessment of Joint Pain at Each Time Point
Baseline (N=104, 106)
|
43.74 scores on a scale
Standard Deviation 23.05
|
47.13 scores on a scale
Standard Deviation 23.22
|
|
Patient Global Assessment of Joint Pain at Each Time Point
Week 2 (N=101, 106)
|
40.98 scores on a scale
Standard Deviation 23.58
|
33.41 scores on a scale
Standard Deviation 22.77
|
|
Patient Global Assessment of Joint Pain at Each Time Point
Week 4 (N=104, 106)
|
38.65 scores on a scale
Standard Deviation 23.42
|
35.75 scores on a scale
Standard Deviation 24.92
|
|
Patient Global Assessment of Joint Pain at Each Time Point
Week 8 (N=104, 106)
|
38.16 scores on a scale
Standard Deviation 23.64
|
31.18 scores on a scale
Standard Deviation 25.44
|
|
Patient Global Assessment of Joint Pain at Each Time Point
Week 12 (N=104, 106)
|
38.38 scores on a scale
Standard Deviation 24.52
|
31.54 scores on a scale
Standard Deviation 26.46
|
|
Patient Global Assessment of Joint Pain at Each Time Point
Week 16 (N=104, 106)
|
25.80 scores on a scale
Standard Deviation 20.52
|
28.97 scores on a scale
Standard Deviation 24.37
|
|
Patient Global Assessment of Joint Pain at Each Time Point
Week 20 (N=104, 106)
|
23.98 scores on a scale
Standard Deviation 20.36
|
27.74 scores on a scale
Standard Deviation 25.83
|
|
Patient Global Assessment of Joint Pain at Each Time Point
Week 24 (N=104, 106)
|
25.43 scores on a scale
Standard Deviation 22.12
|
28.09 scores on a scale
Standard Deviation 26.26
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24Population: Primary analysis set; LOCF was used. "N" indicates the number of participants included in the analyses at each time point.
The participant's global assessment of their arthritis disease activity was assessed by the participant circling a number from 0 to 10 on a horizontal Likert scale ranging from "No Activity at All" (score = 0) to "Worst Activity Imaginable" (score = 10).
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Patient's Global Assessment of Disease Activity at Each Time Point
Baseline (N=104, 106)
|
5.0 scores on a scale
Standard Deviation 2.2
|
5.3 scores on a scale
Standard Deviation 2.1
|
|
Patient's Global Assessment of Disease Activity at Each Time Point
Week 2 (N=101, 106)
|
4.7 scores on a scale
Standard Deviation 2.3
|
4.0 scores on a scale
Standard Deviation 2.1
|
|
Patient's Global Assessment of Disease Activity at Each Time Point
Week 4 (N=104, 106)
|
4.5 scores on a scale
Standard Deviation 2.2
|
4.1 scores on a scale
Standard Deviation 2.3
|
|
Patient's Global Assessment of Disease Activity at Each Time Point
Week 8 (N=104, 106)
|
4.6 scores on a scale
Standard Deviation 2.3
|
3.7 scores on a scale
Standard Deviation 2.4
|
|
Patient's Global Assessment of Disease Activity at Each Time Point
Week 12 (N=104, 106)
|
4.3 scores on a scale
Standard Deviation 2.4
|
3.7 scores on a scale
Standard Deviation 2.5
|
|
Patient's Global Assessment of Disease Activity at Each Time Point
Week 16 (N=104, 106)
|
3.3 scores on a scale
Standard Deviation 2.2
|
3.3 scores on a scale
Standard Deviation 2.3
|
|
Patient's Global Assessment of Disease Activity at Each Time Point
Week 20 (N=104, 106)
|
2.9 scores on a scale
Standard Deviation 2.2
|
3.2 scores on a scale
Standard Deviation 2.6
|
|
Patient's Global Assessment of Disease Activity at Each Time Point
Week 24 (N=104, 106)
|
3.1 scores on a scale
Standard Deviation 2.2
|
3.1 scores on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24Population: Primary analysis set; LOCF was used. "N" indicates the number of participants included in the analyses at each time point.
The global assessment of the participant's arthritis was assessed by the physician circling a number from 0 to 10 on a horizontal Likert scale ranging from "No Activity at All" (score = 0) to "Worst Activity Imaginable" (score = 10).
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Physician Global Assessment of Disease Activity at Each Time Point
Baseline (N=101, 102)
|
5.3 scores on a scale
Standard Deviation 1.7
|
5.4 scores on a scale
Standard Deviation 1.6
|
|
Physician Global Assessment of Disease Activity at Each Time Point
Week 2 (N=99, 106)
|
4.6 scores on a scale
Standard Deviation 1.9
|
4.0 scores on a scale
Standard Deviation 1.8
|
|
Physician Global Assessment of Disease Activity at Each Time Point
Week 4 (N=104, 106)
|
4.2 scores on a scale
Standard Deviation 1.9
|
3.7 scores on a scale
Standard Deviation 1.9
|
|
Physician Global Assessment of Disease Activity at Each Time Point
Week 8 (N=104, 106)
|
4.0 scores on a scale
Standard Deviation 2.0
|
3.4 scores on a scale
Standard Deviation 2.1
|
|
Physician Global Assessment of Disease Activity at Each Time Point
Week 12 (N=104, 106)
|
4.0 scores on a scale
Standard Deviation 2.1
|
3.3 scores on a scale
Standard Deviation 2.1
|
|
Physician Global Assessment of Disease Activity at Each Time Point
Week 16 (N=104, 106)
|
3.1 scores on a scale
Standard Deviation 2.0
|
2.9 scores on a scale
Standard Deviation 2.0
|
|
Physician Global Assessment of Disease Activity at Each Time Point
Week 20 (N=104, 106)
|
2.7 scores on a scale
Standard Deviation 1.7
|
2.9 scores on a scale
Standard Deviation 2.1
|
|
Physician Global Assessment of Disease Activity at Each Time Point
Week 24 (N=104, 106)
|
2.7 scores on a scale
Standard Deviation 1.8
|
2.7 scores on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24Population: Primary analysis set; "N" indicates the number of participants included in the analyses at each time point.
The HAQ-DI asks about the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores). Responses in each functional area are scored from 0 indicating no difficulty to 3 indicating inability to perform a task in that area. The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Each Time Point
Week 2 (N=98, 104)
|
-0.093 scores on a scale
Standard Deviation 0.385
|
-0.266 scores on a scale
Standard Deviation 0.429
|
|
Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Each Time Point
Week 4 (N=103, 105)
|
-0.164 scores on a scale
Standard Deviation 0.383
|
-0.315 scores on a scale
Standard Deviation 0.528
|
|
Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Each Time Point
Week 8 (N=99, 104)
|
-0.208 scores on a scale
Standard Deviation 0.420
|
-0.370 scores on a scale
Standard Deviation 0.466
|
|
Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Each Time Point
Week 12 (N=101, 101)
|
-0.203 scores on a scale
Standard Deviation 0.434
|
-0.388 scores on a scale
Standard Deviation 0.543
|
|
Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Each Time Point
Week 16 (N=98, 101)
|
-0.347 scores on a scale
Standard Deviation 0.476
|
-0.403 scores on a scale
Standard Deviation 0.531
|
|
Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Each Time Point
Week 20 (N=95, 97)
|
-0.412 scores on a scale
Standard Deviation 0.504
|
-0.423 scores on a scale
Standard Deviation 0.578
|
|
Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Each Time Point
Week 24 (N=91, 98)
|
-0.445 scores on a scale
Standard Deviation 0.522
|
-0.475 scores on a scale
Standard Deviation 0.576
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24Population: Primary analysis set; LOCF was used. "N" indicates the number of participants included in the analyses at each time point.
C-Reactive Protein (CRP) was measured from blood samples by a central laboratory as a marker for inflammation.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
C-reactive Protein Levels at Each Time Point
Week 12 (N=104, 106)
|
8.33 mg/L
Standard Deviation 10.62
|
4.09 mg/L
Standard Deviation 6.11
|
|
C-reactive Protein Levels at Each Time Point
Week 16 (N=104, 106)
|
5.17 mg/L
Standard Deviation 7.58
|
3.76 mg/L
Standard Deviation 5.14
|
|
C-reactive Protein Levels at Each Time Point
Week 20 (N=104, 106)
|
4.75 mg/L
Standard Deviation 6.28
|
3.75 mg/L
Standard Deviation 4.55
|
|
C-reactive Protein Levels at Each Time Point
Week 24 (N=104, 106)
|
5.75 mg/L
Standard Deviation 13.10
|
4.40 mg/L
Standard Deviation 5.69
|
|
C-reactive Protein Levels at Each Time Point
Baseline (N=104, 106)
|
9.44 mg/L
Standard Deviation 16.29
|
7.56 mg/L
Standard Deviation 11.77
|
|
C-reactive Protein Levels at Each Time Point
Week 2 (N=100, 105)
|
8.68 mg/L
Standard Deviation 11.49
|
3.97 mg/L
Standard Deviation 6.43
|
|
C-reactive Protein Levels at Each Time Point
Week 4 (N=104, 106)
|
9.75 mg/L
Standard Deviation 15.79
|
4.60 mg/L
Standard Deviation 8.27
|
|
C-reactive Protein Levels at Each Time Point
Week 8 (N=104, 106)
|
8.03 mg/L
Standard Deviation 10.26
|
3.94 mg/L
Standard Deviation 5.37
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 and 24Population: Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants included in the analyses at each time point.
The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. The physical functioning subscale assesses limitations in physical activities because of health problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Short Form 36 Health Survey (SF-36) Physical Functioning Domain Score at Each Time Point
Baseline (N=100, 105)
|
45.16 scores on a scale
Standard Error 2.75
|
45.71 scores on a scale
Standard Error 2.71
|
|
Short Form 36 Health Survey (SF-36) Physical Functioning Domain Score at Each Time Point
Week 4 (N=101, 102)
|
47.54 scores on a scale
Standard Error 2.74
|
51.86 scores on a scale
Standard Error 2.72
|
|
Short Form 36 Health Survey (SF-36) Physical Functioning Domain Score at Each Time Point
Week 12 (N=99, 99)
|
53.02 scores on a scale
Standard Error 2.75
|
52.06 scores on a scale
Standard Error 2.74
|
|
Short Form 36 Health Survey (SF-36) Physical Functioning Domain Score at Each Time Point
Week 24 (N=88, 97)
|
60.38 scores on a scale
Standard Error 2.81
|
55.63 scores on a scale
Standard Error 2.75
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 and 24Population: Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants included in the analyses at each time point.
The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. The vitality sub-score assesses energy and fatigue. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Short Form 36 Health Survey (SF-36) Vitality Domain Score at Each Time Point
Baseline (N=101, 105)
|
42.65 scores on a scale
Standard Error 2.14
|
41.11 scores on a scale
Standard Error 2.11
|
|
Short Form 36 Health Survey (SF-36) Vitality Domain Score at Each Time Point
Week 4 (N=103, 105)
|
46.45 scores on a scale
Standard Error 2.14
|
49.27 scores on a scale
Standard Error 2.12
|
|
Short Form 36 Health Survey (SF-36) Vitality Domain Score at Each Time Point
Week 12 (N=100, 100)
|
47.55 scores on a scale
Standard Error 2.15
|
48.90 scores on a scale
Standard Error 2.14
|
|
Short Form 36 Health Survey (SF-36) Vitality Domain Score at Each Time Point
Week 24 (N=90, 98)
|
53.03 scores on a scale
Standard Error 2.20
|
54.08 scores on a scale
Standard Error 2.15
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 and 24Population: Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants included in the analyses at each time point.
The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. The role-physical subscale assesses limitations in usual role activities because of physical health problems. Least squares means are from a mixed-effect model for repeated measurements (MMRM).
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Short Form 36 Health Survey (SF-36) Role-Physical Domain Score at Each Time Point
Baseline (N=104, 103)
|
49.34 scores on a scale
Standard Error 2.74
|
51.69 scores on a scale
Standard Error 2.73
|
|
Short Form 36 Health Survey (SF-36) Role-Physical Domain Score at Each Time Point
Week 4 (N=102, 105)
|
56.09 scores on a scale
Standard Error 2.76
|
58.09 scores on a scale
Standard Error 2.72
|
|
Short Form 36 Health Survey (SF-36) Role-Physical Domain Score at Each Time Point
Week 12 (N=100, 101)
|
57.74 scores on a scale
Standard Error 2.77
|
57.83 scores on a scale
Standard Error 2.75
|
|
Short Form 36 Health Survey (SF-36) Role-Physical Domain Score at Each Time Point
Week 24 (N=89, 97)
|
65.87 scores on a scale
Standard Error 2.83
|
59.54 scores on a scale
Standard Error 2.77
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 and 24Population: Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants included in the analyses at each time point.
The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning (less pain). Least squares means are from a mixed-effect model for repeated measurements (MMRM).
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Short Form 36 Health Survey (SF-36) Bodily Pain Domain Score at Each Time Point
Baseline (N=104, 106)
|
41.98 scores on a scale
Standard Error 1.98
|
38.39 scores on a scale
Standard Error 1.96
|
|
Short Form 36 Health Survey (SF-36) Bodily Pain Domain Score at Each Time Point
Week 4 (N=103, 105)
|
47.77 scores on a scale
Standard Error 1.99
|
52.17 scores on a scale
Standard Error 1.97
|
|
Short Form 36 Health Survey (SF-36) Bodily Pain Domain Score at Each Time Point
Week 12 (N=101, 101)
|
51.15 scores on a scale
Standard Error 2.00
|
52.79 scores on a scale
Standard Error 1.99
|
|
Short Form 36 Health Survey (SF-36) Bodily Pain Domain Score at Each Time Point
Week 24 (N=88, 98)
|
61.66 scores on a scale
Standard Error 2.08
|
59.42 scores on a scale
Standard Error 2.01
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 and 24Population: Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants included in the analyses at each time point.
The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better quality of life. Least squares means are from a mixed-effect model for repeated measurements (MMRM).
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Short Form 36 Health Survey (SF-36) General Health Perceptions Domain Score at Each Time Point
Baseline (N=104, 106)
|
49.13 scores on a scale
Standard Error 2.03
|
51.77 scores on a scale
Standard Error 2.01
|
|
Short Form 36 Health Survey (SF-36) General Health Perceptions Domain Score at Each Time Point
Week 4 (N=103, 104)
|
52.52 scores on a scale
Standard Error 2.03
|
56.31 scores on a scale
Standard Error 2.02
|
|
Short Form 36 Health Survey (SF-36) General Health Perceptions Domain Score at Each Time Point
Week 12 (N=100, 101)
|
52.21 scores on a scale
Standard Error 2.04
|
54.77 scores on a scale
Standard Error 2.03
|
|
Short Form 36 Health Survey (SF-36) General Health Perceptions Domain Score at Each Time Point
Week 24 (N=89, 98)
|
55.94 scores on a scale
Standard Error 2.09
|
57.44 scores on a scale
Standard Error 2.04
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 and 24Population: Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants included in the analyses at each time point.
The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Short Form 36 Health Survey (SF-36) Social Functioning Domain Score at Each Time Point
Baseline (N=104, 106)
|
65.14 scores on a scale
Standard Error 2.61
|
63.21 scores on a scale
Standard Error 2.58
|
|
Short Form 36 Health Survey (SF-36) Social Functioning Domain Score at Each Time Point
Week 4 (N=103, 105)
|
69.04 scores on a scale
Standard Error 2.61
|
72.03 scores on a scale
Standard Error 2.59
|
|
Short Form 36 Health Survey (SF-36) Social Functioning Domain Score at Each Time Point
Week 12 (N=101, 101)
|
69.68 scores on a scale
Standard Error 12.62
|
69.32 scores on a scale
Standard Error 2.61
|
|
Short Form 36 Health Survey (SF-36) Social Functioning Domain Score at Each Time Point
Week 24 (N=88, 98)
|
78.59 scores on a scale
Standard Error 2.70
|
75.19 scores on a scale
Standard Error 2.63
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 and 24Population: Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants included in the analyses at each time point.
The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better quality of life. The role-emotional subscale assesses limitations in usual role activities because of emotional problems. Least squares means are from a mixed-effect model for repeated measurements (MMRM).
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Short Form 36 Health Survey (SF-36) Role-Emotional Domain Score at Each Time Point
Baseline (N=104, 104)
|
69.23 scores on a scale
Standard Error 2.75
|
66.36 scores on a scale
Standard Error 2.74
|
|
Short Form 36 Health Survey (SF-36) Role-Emotional Domain Score at Each Time Point
Week 4 (N=102, 105)
|
71.92 scores on a scale
Standard Error 2.77
|
72.56 scores on a scale
Standard Error 2.73
|
|
Short Form 36 Health Survey (SF-36) Role-Emotional Domain Score at Each Time Point
Week 12 (N=100, 100)
|
75.86 scores on a scale
Standard Error 2.78
|
71.87 scores on a scale
Standard Error 2.77
|
|
Short Form 36 Health Survey (SF-36) Role-Emotional Domain Score at Each Time Point
Week 24 (N=89, 98)
|
80.12 scores on a scale
Standard Error 2.86
|
76.30 scores on a scale
Standard Error 2.78
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 and 24Population: Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants included in the analyses at each time point.
The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better quality of life. The mental health sub-score assesses general mental health (psychological distress and well-being). Least squares means are from a mixed-effect model for repeated measurements (MMRM).
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Short Form 36 Health Survey (SF-36) Mental Health Domain Score at Each Time Point
Baseline (N=104, 104)
|
70.14 scores on a scale
Standard Error 1.90
|
66.56 scores on a scale
Standard Error 1.88
|
|
Short Form 36 Health Survey (SF-36) Mental Health Domain Score at Each Time Point
Week 4 (N=103, 102)
|
69.74 scores on a scale
Standard Error 1.90
|
72.01 scores on a scale
Standard Error 1.90
|
|
Short Form 36 Health Survey (SF-36) Mental Health Domain Score at Each Time Point
Week 12 (N=100, 100)
|
72.05 scores on a scale
Standard Error 1.92
|
72.56 scores on a scale
Standard Error 1.90
|
|
Short Form 36 Health Survey (SF-36) Mental Health Domain Score at Each Time Point
Week 24 (N=89, 97)
|
75.71 scores on a scale
Standard Error 1.96
|
74.20 scores on a scale
Standard Error 1.92
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 and 24Population: Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants employed and included in the analyses at each time point.
This self-administered questionnaire is designed to address impairment to the work productivity and activity of participants due to rheumatoid arthritis in the past 7 days. Percent of work time missed is derived from the number of hours of work missed due to rheumatoid arthritis symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. Least squares means are from a mixed-effect model for repeated measurements (MMRM).
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Work Time Missed (Absenteeism) at Each Time Point
Baseline (N=46, 46)
|
3.54 percent work time missed
Standard Error 2.04
|
5.88 percent work time missed
Standard Error 2.03
|
|
Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Work Time Missed (Absenteeism) at Each Time Point
Week 4 (N=46, 42)
|
4.18 percent work time missed
Standard Error 2.03
|
4.50 percent work time missed
Standard Error 2.12
|
|
Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Work Time Missed (Absenteeism) at Each Time Point
Week 12 (N=45, 40)
|
8.07 percent work time missed
Standard Error 2.06
|
4.46 percent work time missed
Standard Error 2.16
|
|
Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Work Time Missed (Absenteeism) at Each Time Point
Week 24 (N=38, 43)
|
5.22 percent work time missed
Standard Error 2.21
|
3.77 percent work time missed
Standard Error 2.09
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 and 24Population: Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants employed and included in the analyses at each time point.
This self-administered questionnaire is designed to address impairment to the work productivity and activity of participants due to rheumatoid arthritis in the past 7 days. Percent impairment while working was derived from the participant's assessment of the degree to which rheumatoid arthritis affected their productivity while working. A higher percentage indicates greater impairment and less productivity. Least squares means are from a mixed-effect model for repeated measurements (MMRM).
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Impairment While Working (Presenteeism) at Each Time Point
Baseline (N=45, 45)
|
34.39 percent impairment while working
Standard Error 3.39
|
36.86 percent impairment while working
Standard Error 3.39
|
|
Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Impairment While Working (Presenteeism) at Each Time Point
Week 4 (N=44, 43)
|
31.91 percent impairment while working
Standard Error 3.41
|
25.04 percent impairment while working
Standard Error 3.44
|
|
Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Impairment While Working (Presenteeism) at Each Time Point
Week 12 (N=39, 40)
|
25.49 percent impairment while working
Standard Error 3.52
|
24.61 percent impairment while working
Standard Error 3.50
|
|
Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Impairment While Working (Presenteeism) at Each Time Point
Week 24 (N=37, 40)
|
21.46 percent impairment while working
Standard Error 3.57
|
21.10 percent impairment while working
Standard Error 3.49
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 and 24Population: Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants included in the analyses at each time point.
This self-administered questionnaire is designed to address impairment to the work productivity and activity of participants due to rheumatoid arthritis. Percent activity impairment is derived from the patient's assessment of the degree to which rheumatoid arthritis affected their regular daily activities. A higher percentage indicates greater impairment and less productivity. Least squares means are from a mixed-effect model for repeated measurements (MMRM).
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Activity Impairment at Each Time Point
Baseline (N=103, 106)
|
49.29 percent activity impairment
Standard Error 2.56
|
50.38 percent activity impairment
Standard Error 2.53
|
|
Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Activity Impairment at Each Time Point
Week 4 (N=102, 104)
|
41.22 percent activity impairment
Standard Error 2.57
|
38.67 percent activity impairment
Standard Error 2.55
|
|
Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Activity Impairment at Each Time Point
Week 12 (N=99, 99)
|
39.16 percent activity impairment
Standard Error 2.59
|
35.98 percent activity impairment
Standard Error 2.58
|
|
Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Activity Impairment at Each Time Point
Week 24 (N=88, 96)
|
29.91 percent activity impairment
Standard Error 2.68
|
30.57 percent activity impairment
Standard Error 2.61
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 and 24Population: Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants employed and included in the analyses at each time point.
This self-administered questionnaire is designed to address impairment to the work productivity and activity of participants due to rheumatoid arthritis in the past 7 days. Percent overall work impairment takes into account both hours missed due to rheumatoid arthritis symptoms and the participant's assessment of the degree to which rheumatoid arthritis affected their productivity while working. A higher percentage indicates greater impairment and less productivity. Least squares means are from a mixed-effect model for repeated measurements (MMRM).
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Overall Work Impairment at Each Time Point
Baseline (N=45, 46)
|
34.79 percent overall work impairment
Standard Error 3.80
|
36.71 percent overall work impairment
Standard Error 3.76
|
|
Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Overall Work Impairment at Each Time Point
Week 4 (N=46, 42)
|
33.14 percent overall work impairment
Standard Error 3.77
|
26.14 percent overall work impairment
Standard Error 3.87
|
|
Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Overall Work Impairment at Each Time Point
Week 12 (N=45, 40)
|
27.23 percent overall work impairment
Standard Error 3.80
|
26.22 percent overall work impairment
Standard Error 3.92
|
|
Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Overall Work Impairment at Each Time Point
Week 24 (N=38, 42)
|
23.93 percent overall work impairment
Standard Error 3.98
|
22.58 percent overall work impairment
Standard Error 3.86
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24Population: Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants included in the analyses at each time point.
The participant's assessment of fatigue was collected using a single-item 100 mm visual analogue scale. The participant was asked to draw a vertical line through a horizontal line to indicate the degree of fatigue they experienced because of their condition over the past week. The horizontal line is 100 mm in length with '0' and 'no fatigue' on the left end of the line and '100' and 'extreme fatigue' on the right end of the line. Least squares means are from a mixed-effect model for repeated measurements (MMRM).
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Participant Assessment of Fatigue at Each Time Point
Baseline (N=103, 105)
|
49.38 scores on a scale
Standard Error 2.63
|
50.05 scores on a scale
Standard Error 2.61
|
|
Participant Assessment of Fatigue at Each Time Point
Week 2 (N=99, 104)
|
50.31 scores on a scale
Standard Error 2.66
|
38.68 scores on a scale
Standard Error 2.61
|
|
Participant Assessment of Fatigue at Each Time Point
Week 4 (N=103, 105)
|
46.48 scores on a scale
Standard Error 2.63
|
40.04 scores on a scale
Standard Error 2.61
|
|
Participant Assessment of Fatigue at Each Time Point
Week 8 (N=99, 104)
|
44.09 scores on a scale
Standard Error 2.66
|
39.32 scores on a scale
Standard Error 2.62
|
|
Participant Assessment of Fatigue at Each Time Point
Week 12 (N=100, 100)
|
45.51 scores on a scale
Standard Error 2.66
|
41.43 scores on a scale
Standard Error 2.64
|
|
Participant Assessment of Fatigue at Each Time Point
Week 16 (N=98, 101)
|
38.73 scores on a scale
Standard Error 2.67
|
35.15 scores on a scale
Standard Error 2.64
|
|
Participant Assessment of Fatigue at Each Time Point
Week 20 (N=95, 97)
|
29.82 scores on a scale
Standard Error 2.69
|
35.20 scores on a scale
Standard Error 2.66
|
|
Participant Assessment of Fatigue at Each Time Point
Week 24 (N=90, 98)
|
34.35 scores on a scale
Standard Error 2.72
|
33.87 scores on a scale
Standard Error 2.65
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 and 24Population: Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants included in the analyses at each time point.
The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Shortness of Breath (1 item). Sleep Disturbance measures the ability to fall asleep and to maintain restful sleep. In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Medical Outcomes Study (MOS) Sleep Disturbance Scale at Each Time Point
Baseline (N=102, 104)
|
45.02 scores on a scale
Standard Error 1.00
|
44.95 scores on a scale
Standard Error 1.00
|
|
Medical Outcomes Study (MOS) Sleep Disturbance Scale at Each Time Point
Week 4 (N=103, 104)
|
46.42 scores on a scale
Standard Error 1.00
|
46.38 scores on a scale
Standard Error 1.00
|
|
Medical Outcomes Study (MOS) Sleep Disturbance Scale at Each Time Point
Week 12 (N=98, 100)
|
46.10 scores on a scale
Standard Error 1.01
|
46.91 scores on a scale
Standard Error 1.00
|
|
Medical Outcomes Study (MOS) Sleep Disturbance Scale at Each Time Point
Week 24 (N=86, 96)
|
48.23 scores on a scale
Standard Error 1.04
|
47.38 scores on a scale
Standard Error 1.01
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 and 24Population: Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants included in the analyses at each time point.
The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Medical Outcomes Study (MOS) Sleep Shortness of Breath or Headache Scale at Each Time Point
Baseline (N=104, 106)
|
51.63 scores on a scale
Standard Error 0.95
|
49.25 scores on a scale
Standard Error 0.94
|
|
Medical Outcomes Study (MOS) Sleep Shortness of Breath or Headache Scale at Each Time Point
Week 4 (N=103, 104)
|
51.38 scores on a scale
Standard Error 0.95
|
50.20 scores on a scale
Standard Error 0.95
|
|
Medical Outcomes Study (MOS) Sleep Shortness of Breath or Headache Scale at Each Time Point
Week 12 (N=99, 98)
|
50.34 scores on a scale
Standard Error 0.97
|
49.77 scores on a scale
Standard Error 0.97
|
|
Medical Outcomes Study (MOS) Sleep Shortness of Breath or Headache Scale at Each Time Point
Week 24 (N=89, 97)
|
51.21 scores on a scale
Standard Error 1.00
|
50.31 scores on a scale
Standard Error 0.97
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 and 24Population: Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants included in the analyses at each time point.
The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Shortness of Breath (1 item). In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Medical Outcomes Study (MOS) Sleep Snoring Scale at Each Time Point
Baseline (N=101, 103)
|
47.78 scores on a scale
Standard Error 0.95
|
47.13 scores on a scale
Standard Error 0.94
|
|
Medical Outcomes Study (MOS) Sleep Snoring Scale at Each Time Point
Week 4 (N=102, 102)
|
49.14 scores on a scale
Standard Error 0.94
|
47.91 scores on a scale
Standard Error 0.94
|
|
Medical Outcomes Study (MOS) Sleep Snoring Scale at Each Time Point
Week 12 (N=99, 97)
|
49.47 scores on a scale
Standard Error 0.95
|
49.04 scores on a scale
Standard Error 0.95
|
|
Medical Outcomes Study (MOS) Sleep Snoring Scale at Each Time Point
Week 24 (N=86, 93)
|
49.95 scores on a scale
Standard Error 0.98
|
48.25 scores on a scale
Standard Error 0.96
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 and 24Population: Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants included in the analyses at each time point.
The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). Sleep Adequacy measures sleep sufficiency in terms of whether the participant sleeps enough to provide restoration of wakefulness. In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. For sleep adequacy a higher score indicates better sleep quality. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Medical Outcomes Study (MOS) Sleep Adequacy Scale at Each Time Point
Baseline (N=102, 105)
|
47.12 scores on a scale
Standard Error 0.98
|
46.72 scores on a scale
Standard Error 0.97
|
|
Medical Outcomes Study (MOS) Sleep Adequacy Scale at Each Time Point
Week 4 (N=103, 104)
|
47.63 scores on a scale
Standard Error 0.98
|
47.42 scores on a scale
Standard Error 0.97
|
|
Medical Outcomes Study (MOS) Sleep Adequacy Scale at Each Time Point
Week 12 (N=99, 99)
|
46.86 scores on a scale
Standard Error 0.99
|
47.73 scores on a scale
Standard Error 0.98
|
|
Medical Outcomes Study (MOS) Sleep Adequacy Scale at Each Time Point
Week 24 (N=87, 97)
|
48.73 scores on a scale
Standard Error 1.02
|
48.66 scores on a scale
Standard Error 0.99
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 and 24Population: Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants included in the analyses at each time point.
The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). Daytime somnolence measures drowsiness or sleepiness during the day. In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Medical Outcomes Study (MOS) Sleep Daytime Somnolence Scale at Each Time Point
Baseline (N=103, 106)
|
46.82 scores on a scale
Standard Error 1.01
|
46.27 scores on a scale
Standard Error 1.00
|
|
Medical Outcomes Study (MOS) Sleep Daytime Somnolence Scale at Each Time Point
Week 4 (N=103, 104)
|
46.62 scores on a scale
Standard Error 1.01
|
48.72 scores on a scale
Standard Error 1.01
|
|
Medical Outcomes Study (MOS) Sleep Daytime Somnolence Scale at Each Time Point
Week 12 (N=99, 99)
|
47.80 scores on a scale
Standard Error 1.02
|
48.05 scores on a scale
Standard Error 1.02
|
|
Medical Outcomes Study (MOS) Sleep Daytime Somnolence Scale at Each Time Point
Week 24 (N=87, 97)
|
48.31 scores on a scale
Standard Error 1.05
|
48.80 scores on a scale
Standard Error 1.02
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 and 24Population: Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants included in the analyses at each time point.
The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). The scale also produces two indices. The Sleep Problems Index-I is drawn from 6 items in the four domains including Sleep Disturbance (2 items), Sleep Adequacy (2 items), Shortness of Breath (1 item), and Daytime Somnolence (1 item). In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Medical Outcomes Study (MOS) Sleep Problems Index I at Each Time Point
Baseline (N=102, 105)
|
46.16 scores on a scale
Standard Error 0.92
|
45.53 scores on a scale
Standard Error 0.91
|
|
Medical Outcomes Study (MOS) Sleep Problems Index I at Each Time Point
Week 4 (N=103, 104)
|
46.91 scores on a scale
Standard Error 0.92
|
46.63 scores on a scale
Standard Error 0.91
|
|
Medical Outcomes Study (MOS) Sleep Problems Index I at Each Time Point
Week 12 (N=99, 97)
|
46.82 scores on a scale
Standard Error 0.92
|
47.17 scores on a scale
Standard Error 0.92
|
|
Medical Outcomes Study (MOS) Sleep Problems Index I at Each Time Point
Week 24 (N=87, 97)
|
48.39 scores on a scale
Standard Error 0.95
|
47.80 scores on a scale
Standard Error 0.92
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 12 and 24Population: Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants included in the analyses at each time point.
The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). The scale also produces two indices. Index-II uses 9 items from four domains including Sleep Disturbance (4 items), Sleep Adequacy (2 items), Shortness of Breath (1 item), and Daytime Somnolence (2 items). In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received placebo subcutaneous injections once a week for 12 weeks.
|
Etanercept
n=106 Participants
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
|
|---|---|---|
|
Medical Outcomes Study (MOS) Sleep Problems Index II at Each Time Point
Baseline (N=101, 104)
|
45.69 scores on a scale
Standard Error 0.93
|
45.16 scores on a scale
Standard Error 0.92
|
|
Medical Outcomes Study (MOS) Sleep Problems Index II at Each Time Point
Week 4 (N=103, 104)
|
46.63 scores on a scale
Standard Error 0.93
|
48.84 scores on a scale
Standard Error 0.92
|
|
Medical Outcomes Study (MOS) Sleep Problems Index II at Each Time Point
Week 12 (N=98, 97)
|
46.51 scores on a scale
Standard Error 0.94
|
47.06 scores on a scale
Standard Error 0.94
|
|
Medical Outcomes Study (MOS) Sleep Problems Index II at Each Time Point
Week 24 (N=86, 96)
|
48.55 scores on a scale
Standard Error 0.96
|
47.88 scores on a scale
Standard Error 0.94
|
Adverse Events
Placebo-Etanercept
Etanercept-Etanercept
Serious adverse events
| Measure |
Placebo-Etanercept
n=104 participants at risk
Participants received placebo subcutaneous injections once a week for 12 weeks and then open-label etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks. All participants continued their disease modifying anti-rheumatic drug (DMARD) treatment throughout the 24-week study period.
|
Etanercept-Etanercept
n=106 participants at risk
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then open-label etanercept 50 mg subcutaneous injection for the next 12 weeks. All participants continued their DMARD treatment throughout the 24-week study period.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.96%
1/104 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
0.94%
1/106 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
|
Cardiac disorders
Coronary artery disease
|
0.96%
1/104 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
0.00%
0/106 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/104 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
0.94%
1/106 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.96%
1/104 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
0.00%
0/106 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.96%
1/104 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
0.00%
0/106 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/104 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
0.94%
1/106 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.96%
1/104 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
0.00%
0/106 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
|
Investigations
Alanine aminotransferase increased
|
0.96%
1/104 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
0.00%
0/106 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
|
Investigations
Aspartate aminotransferase increased
|
0.96%
1/104 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
0.00%
0/106 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/104 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
0.94%
1/106 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/104 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
0.94%
1/106 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
Other adverse events
| Measure |
Placebo-Etanercept
n=104 participants at risk
Participants received placebo subcutaneous injections once a week for 12 weeks and then open-label etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks. All participants continued their disease modifying anti-rheumatic drug (DMARD) treatment throughout the 24-week study period.
|
Etanercept-Etanercept
n=106 participants at risk
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then open-label etanercept 50 mg subcutaneous injection for the next 12 weeks. All participants continued their DMARD treatment throughout the 24-week study period.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
5.8%
6/104 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
4.7%
5/106 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
|
General disorders
Fatigue
|
3.8%
4/104 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
5.7%
6/106 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
|
General disorders
Injection site erythema
|
10.6%
11/104 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
12.3%
13/106 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
|
General disorders
Injection site pain
|
5.8%
6/104 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
4.7%
5/106 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
|
General disorders
Injection site pruritus
|
7.7%
8/104 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
6.6%
7/106 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
|
General disorders
Injection site rash
|
5.8%
6/104 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
8.5%
9/106 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
|
Infections and infestations
Bronchitis
|
3.8%
4/104 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
6.6%
7/106 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
|
Infections and infestations
Nasopharyngitis
|
11.5%
12/104 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
5.7%
6/106 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
|
Infections and infestations
Sinusitis
|
6.7%
7/104 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
7.5%
8/106 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
13/104 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
7.5%
8/106 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
|
Infections and infestations
Urinary tract infection
|
3.8%
4/104 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
6.6%
7/106 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.8%
5/104 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
5.7%
6/106 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
7/104 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
4.7%
5/106 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.96%
1/104 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
5.7%
6/106 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
11.5%
12/104 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
11.3%
12/106 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
|
Nervous system disorders
Headache
|
15.4%
16/104 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
8.5%
9/106 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.9%
3/104 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
5.7%
6/106 • 28 weeks
The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
|
Additional Information
Study Director
Amgen Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER