Trial Outcomes & Findings for Safety and Efficacy Study of Adalimumab in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate (NCT NCT00538902)
NCT ID: NCT00538902
Last Updated: 2011-04-11
Results Overview
American College of Rheumatology (ACR) criteria improvement consisting of 20% (ACR20) reduction in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. Week 12 = end of Double-Blind period.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
302 participants
Primary outcome timeframe
Week 12
Results posted on
2011-04-11
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 12 weeks.
|
Adalimumab 40 mg
Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 24 weeks.
|
Adalimumab 80 mg
Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 12 weeks.
|
|---|---|---|---|
|
DB Wk 0 Through 12 (Primary D/C Reasons)
STARTED
|
60
|
121
|
121
|
|
DB Wk 0 Through 12 (Primary D/C Reasons)
COMPLETED
|
59
|
119
|
116
|
|
DB Wk 0 Through 12 (Primary D/C Reasons)
NOT COMPLETED
|
1
|
2
|
5
|
|
OL Wk 24 to End (Primary D/C Reasons)
STARTED
|
59
|
119
|
116
|
|
OL Wk 24 to End (Primary D/C Reasons)
COMPLETED
|
23
|
55
|
52
|
|
OL Wk 24 to End (Primary D/C Reasons)
NOT COMPLETED
|
36
|
64
|
64
|
Reasons for withdrawal
| Measure |
Placebo
Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 12 weeks.
|
Adalimumab 40 mg
Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 24 weeks.
|
Adalimumab 80 mg
Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 12 weeks.
|
|---|---|---|---|
|
DB Wk 0 Through 12 (Primary D/C Reasons)
Adverse Event
|
1
|
2
|
3
|
|
DB Wk 0 Through 12 (Primary D/C Reasons)
Withdrawal by Subject
|
0
|
0
|
1
|
|
DB Wk 0 Through 12 (Primary D/C Reasons)
Lost to Follow-up
|
0
|
0
|
1
|
|
DB Wk 0 Through 12 (Primary D/C Reasons)
Various
|
0
|
0
|
0
|
|
OL Wk 24 to End (Primary D/C Reasons)
Adverse Event
|
2
|
10
|
11
|
|
OL Wk 24 to End (Primary D/C Reasons)
Withdrawal by Subject
|
15
|
19
|
25
|
|
OL Wk 24 to End (Primary D/C Reasons)
Lost to Follow-up
|
1
|
10
|
6
|
|
OL Wk 24 to End (Primary D/C Reasons)
Various
|
18
|
25
|
22
|
Baseline Characteristics
Safety and Efficacy Study of Adalimumab in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate
Baseline characteristics by cohort
| Measure |
Placebo
n=60 Participants
Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
|
Adalimumab 40 mg
n=121 Participants
Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
|
Adalimumab 80 mg
n=121 Participants
Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
|
Total
n=302 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
58 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
284 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
254 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Region of Enrollment
China
|
60 participants
n=5 Participants
|
121 participants
n=7 Participants
|
121 participants
n=5 Participants
|
302 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Intent-to-treat population (ITT): all randomized subjects who received at least 1 dose of study drug during the double-blind portion of the study.
American College of Rheumatology (ACR) criteria improvement consisting of 20% (ACR20) reduction in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. Week 12 = end of Double-Blind period.
Outcome measures
| Measure |
Placebo
n=60 Participants
Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
|
Adalimumab 40 mg
n=121 Participants
Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
|
Adalimumab 80 mg
n=121 Participants
Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
|
|---|---|---|---|
|
Number of Participants With American College of Rheumatology (ACR)20 at Week 12 of the Double-Blind Period
|
21 Participants
|
69 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the double-blind portion of the study), non-responder imputation (NRI; missing ACR responses imputed as non-responders).
American College of Rheumatology (ACR) criteria improvement consisting of 50% or 70% (ACR50/70) reduction in tender or swollen joint counts and 50% or 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. Week 12 = end of Double-blind period.
Outcome measures
| Measure |
Placebo
n=60 Participants
Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
|
Adalimumab 40 mg
n=121 Participants
Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
|
Adalimumab 80 mg
n=121 Participants
Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
|
|---|---|---|---|
|
Number of Participants Achieving American College of Rheumatology (ACR)50/70 at Week 12 of the Double-Blind Period
ACR50
|
9 Participants
|
39 Participants
|
29 Participants
|
|
Number of Participants Achieving American College of Rheumatology (ACR)50/70 at Week 12 of the Double-Blind Period
ACR70
|
2 Participants
|
19 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92Population: Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.
American College of Rheumatology (ACR) criteria improvement in a subject's disease condition versus Baseline consisting of 20% (ACR20) reduction in tender or swollen joint counts and 20/50/70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Outcome measures
| Measure |
Placebo
n=294 Participants
Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
|
Adalimumab 40 mg
Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
|
Adalimumab 80 mg
Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
|
|---|---|---|---|
|
Number of Participants Achieving American College of Rheumatology (ACR)20 Response Through Week 92 of Open-Label Period
Week 0 Responders (n = 293)
|
152 Participants
|
—
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)20 Response Through Week 92 of Open-Label Period
Week 24 Responders (n = 208)
|
153 Participants
|
—
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)20 Response Through Week 92 of Open-Label Period
Week 36 Responders (n = 200)
|
158 Participants
|
—
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)20 Response Through Week 92 of Open-Label Period
Week 48 Responders (n = 183)
|
147 Participants
|
—
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)20 Response Through Week 92 of Open-Label Period
Week 60 Responders (n = 166)
|
131 Participants
|
—
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)20 Response Through Week 92 of Open-Label Period
Week 72 Responders (n = 150)
|
108 Participants
|
—
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)20 Response Through Week 92 of Open-Label Period
Week 84 Responders (n = 137)
|
111 Participants
|
—
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)20 Response Through Week 92 of Open-Label Period
Week 4 Responders (n = 289)
|
179 Participants
|
—
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)20 Response Through Week 92 of Open-Label Period
Week 8 Responders (n = 283)
|
183 Participants
|
—
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)20 Response Through Week 92 of Open-Label Period
Week 12 Responders (n = 279)
|
207 Participants
|
—
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)20 Response Through Week 92 of Open-Label Period
Week 92 Responders (n = 130)
|
105 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92Population: Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.
American College of Rheumatology (ACR) criteria improvement in a subject's disease condition versus Baseline consisting of 50% (ACR50) reduction in tender or swollen joint counts and 20/50/70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Outcome measures
| Measure |
Placebo
n=294 Participants
Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
|
Adalimumab 40 mg
Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
|
Adalimumab 80 mg
Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
|
|---|---|---|---|
|
Number of Participants Achieving American College of Rheumatology (ACR)50 Response Through Week 92 of Open-Label Period
Week 4 Responders (n = 289)
|
95 Participants
|
—
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)50 Response Through Week 92 of Open-Label Period
Week 8 Responders (n = 283)
|
103 Participants
|
—
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)50 Response Through Week 92 of Open-Label Period
Week 12 Responders (n = 279)
|
119 Participants
|
—
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)50 Response Through Week 92 of Open-Label Period
Week 24 Responders (n = 208)
|
96 Participants
|
—
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)50 Response Through Week 92 of Open-Label Period
Week 48 Responders (n = 183)
|
94 Participants
|
—
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)50 Response Through Week 92 of Open-Label Period
Week 60 Responders (n = 166)
|
74 Participants
|
—
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)50 Response Through Week 92 of Open-Label Period
Week 72 Responders (n = 150)
|
79 Participants
|
—
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)50 Response Through Week 92 of Open-Label Period
Week 84 Responders (n = 137)
|
74 Participants
|
—
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)50 Response Through Week 92 of Open-Label Period
Week 0 Responders (n = 293)
|
77 Participants
|
—
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)50 Response Through Week 92 of Open-Label Period
Week 36 Responders (n = 200)
|
102 Participants
|
—
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)50 Response Through Week 92 of Open-Label Period
Week 92 Responders (n = 130)
|
69 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92Population: Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.
American College of Rheumatology (ACR) criteria improvement in a subject's disease condition versus Baseline consisting of 70% (ACR70) reduction in tender or swollen joint counts and 20/50/70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Outcome measures
| Measure |
Placebo
n=294 Participants
Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
|
Adalimumab 40 mg
Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
|
Adalimumab 80 mg
Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
|
|---|---|---|---|
|
Number of Participants Achieving American College of Rheumatology (ACR)70 Response Through Week 92 of Open-Label Period
Week 36 Responders (n = 200)
|
48 Participants
|
—
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)70 Response Through Week 92 of Open-Label Period
Week 48 Responders (n = 183)
|
40 Participants
|
—
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)70 Response Through Week 92 of Open-Label Period
Week 0 Responders (n = 293)
|
32 Participants
|
—
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)70 Response Through Week 92 of Open-Label Period
Week 4 Responders (n = 289)
|
39 Participants
|
—
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)70 Response Through Week 92 of Open-Label Period
Week 8 Responders (n = 283)
|
49 Participants
|
—
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)70 Response Through Week 92 of Open-Label Period
Week 12 Responders (n = 279)
|
52 Participants
|
—
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)70 Response Through Week 92 of Open-Label Period
Week 24 Responders (n = 208)
|
39 Participants
|
—
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)70 Response Through Week 92 of Open-Label Period
Week 60 Responders (n = 166)
|
37 Participants
|
—
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)70 Response Through Week 92 of Open-Label Period
Week 72 Responders (n = 150)
|
30 Participants
|
—
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)70 Response Through Week 92 of Open-Label Period
Week 84 Responders (n = 137)
|
38 Participants
|
—
|
—
|
|
Number of Participants Achieving American College of Rheumatology (ACR)70 Response Through Week 92 of Open-Label Period
Week 92 Responders (n = 130)
|
34 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the double-blind portion of the study), Last Observation Carried Forward (LOCF).
Sixty-eight or 66 joints or regions (34 or 32 per body side \[hip joints excluded\]) were assessed by pressure and joint manipulation on physical examination for tender joint count (TJC) or swollen joint count (SJC), respectively. Both joint tenderness and swelling were classified as either present ("1"), absent ("0"), replaced ("9"), or no assessment ("NA"). The Total TJC or SJC was derived as the sum of all 1s evaluated; the range for TJC and SJC were 0 - 68 and 0 - 66, respectively. The higher the joint count, the worse the rheumatoid arthritis. Week 12 = end of Double-Blind period.
Outcome measures
| Measure |
Placebo
n=60 Participants
Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
|
Adalimumab 40 mg
n=120 Participants
Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
|
Adalimumab 80 mg
n=120 Participants
Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
|
|---|---|---|---|
|
Mean Change in Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Week 12 of the Double-Blind Period
SJC Week 12
|
-4.7 Joints
Standard Deviation 8.7
|
-8.6 Joints
Standard Deviation 8.6
|
-6.4 Joints
Standard Deviation 6.6
|
|
Mean Change in Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Week 12 of the Double-Blind Period
TJC Week 12
|
-7.0 Joints
Standard Deviation 12.1
|
-12.2 Joints
Standard Deviation 14.9
|
-8.8 Joints
Standard Deviation 12.6
|
SECONDARY outcome
Timeframe: Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92Population: Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.
Sixty-eight or 66 joints or regions (34 or 32 per body side \[hip joints excluded\]) were assessed by pressure and joint manipulation on physical examination for tender joint count (TJC) or swollen joint count (SJC), respectively. Both joint tenderness and swelling were classified as either present ("1"), absent ("0"), replaced ("9"), or no assessment ("NA"). The Total TJC or SJC was derived as the sum of all 1s evaluated; the range for TJC and SJC were 0 - 68 and 0 - 66, respectively. The higher the joint count, the worse the rheumatoid arthritis. Week 12 = end of Double-Blind period.
Outcome measures
| Measure |
Placebo
n=294 Participants
Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
|
Adalimumab 40 mg
Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
|
Adalimumab 80 mg
Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
|
|---|---|---|---|
|
Mean Change in Tender Joint Count (TJC) Through Week 92 of the Open-Label Period
Baseline
|
22.8 Joints
Standard Deviation 16.07
|
—
|
—
|
|
Mean Change in Tender Joint Count (TJC) Through Week 92 of the Open-Label Period
Week 0 (n = 293)
|
-9.9 Joints
Standard Deviation 13.44
|
—
|
—
|
|
Mean Change in Tender Joint Count (TJC) Through Week 92 of the Open-Label Period
Week 4 (n = 289)
|
-12.3 Joints
Standard Deviation 13.08
|
—
|
—
|
|
Mean Change in Tender Joint Count (TJC) Through Week 92 of the Open-Label Period
Week 8 (n = 283)
|
-13.4 Joints
Standard Deviation 13.68
|
—
|
—
|
|
Mean Change in Tender Joint Count (TJC) Through Week 92 of the Open-Label Period
Week 12 (n = 279)
|
-14.4 Joints
Standard Deviation 14.15
|
—
|
—
|
|
Mean Change in Tender Joint Count (TJC) Through Week 92 of the Open-Label Period
Week 36 (n = 200)
|
-16.5 Joints
Standard Deviation 13.57
|
—
|
—
|
|
Mean Change in Tender Joint Count (TJC) Through Week 92 of the Open-Label Period
Week 48 (n = 183)
|
-17.6 Joints
Standard Deviation 14.24
|
—
|
—
|
|
Mean Change in Tender Joint Count (TJC) Through Week 92 of the Open-Label Period
Week 60 (n = 166)
|
-17.0 Joints
Standard Deviation 13.99
|
—
|
—
|
|
Mean Change in Tender Joint Count (TJC) Through Week 92 of the Open-Label Period
Week 72 (n = 150)
|
-18.0 Joints
Standard Deviation 14.15
|
—
|
—
|
|
Mean Change in Tender Joint Count (TJC) Through Week 92 of the Open-Label Period
Week 84 (n = 137)
|
-18.5 Joints
Standard Deviation 15.18
|
—
|
—
|
|
Mean Change in Tender Joint Count (TJC) Through Week 92 of the Open-Label Period
Week 92 (n = 130)
|
-18.0 Joints
Standard Deviation 14.23
|
—
|
—
|
|
Mean Change in Tender Joint Count (TJC) Through Week 92 of the Open-Label Period
Week 24 (n = 208)
|
-16.4 Joints
Standard Deviation 13.54
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92Population: Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.
Sixty-eight or 66 joints or regions (34 or 32 per body side \[hip joints excluded\]) were assessed by pressure and joint manipulation on physical examination for tender joint count (TJC) or swollen joint count (SJC), respectively. Both joint tenderness and swelling were classified as either present ("1"), absent ("0"), replaced ("9"), or no assessment ("NA"). The Total TJC or SJC was derived as the sum of all 1s evaluated; the range for TJC and SJC were 0 - 68 and 0 - 66, respectively. The higher the joint count, the worse the rheumatoid arthritis. Week 12 = end of Double-Blind period.
Outcome measures
| Measure |
Placebo
n=294 Participants
Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
|
Adalimumab 40 mg
Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
|
Adalimumab 80 mg
Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
|
|---|---|---|---|
|
Mean Change in Swollen Joint Count (SJC) Through Week 92 of the Open-Label Period
Baseline
|
11.2 Joints
Standard Deviation 7.74
|
—
|
—
|
|
Mean Change in Swollen Joint Count (SJC) Through Week 92 of the Open-Label Period
Week 0 (n = 293)
|
-6.9 Joints
Standard Deviation 8.03
|
—
|
—
|
|
Mean Change in Swollen Joint Count (SJC) Through Week 92 of the Open-Label Period
Week 4 (n = 289)
|
-7.4 Joints
Standard Deviation 8.87
|
—
|
—
|
|
Mean Change in Swollen Joint Count (SJC) Through Week 92 of the Open-Label Period
Week 8 (n = 283)
|
-8.3 Joints
Standard Deviation 8.16
|
—
|
—
|
|
Mean Change in Swollen Joint Count (SJC) Through Week 92 of the Open-Label Period
Week 12 (n = 279)
|
-8.8 Joints
Standard Deviation 7.87
|
—
|
—
|
|
Mean Change in Swollen Joint Count (SJC) Through Week 92 of the Open-Label Period
Week 24 (n = 208)
|
-9.3 Joints
Standard Deviation 8.62
|
—
|
—
|
|
Mean Change in Swollen Joint Count (SJC) Through Week 92 of the Open-Label Period
Week 36 (n = 200)
|
-9.3 Joints
Standard Deviation 8.41
|
—
|
—
|
|
Mean Change in Swollen Joint Count (SJC) Through Week 92 of the Open-Label Period
Week 48 (n = 183)
|
-9.7 Joints
Standard Deviation 8.45
|
—
|
—
|
|
Mean Change in Swollen Joint Count (SJC) Through Week 92 of the Open-Label Period
Week 60 (n = 166)
|
-9.0 Joints
Standard Deviation 7.95
|
—
|
—
|
|
Mean Change in Swollen Joint Count (SJC) Through Week 92 of the Open-Label Period
Week 72 (n = 150)
|
-9.2 Joints
Standard Deviation 7.90
|
—
|
—
|
|
Mean Change in Swollen Joint Count (SJC) Through Week 92 of the Open-Label Period
Week 84 (n = 137)
|
-9.5 Joints
Standard Deviation 7.99
|
—
|
—
|
|
Mean Change in Swollen Joint Count (SJC) Through Week 92 of the Open-Label Period
Week 92 (n = 130)
|
-9.5 Joints
Standard Deviation 8.00
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intent-to-Treat (ITT) population (all subjects who received at least 1 dose of study drug during the double-blind period), Last Observation Carried Forward (LOCF).
Visual analog scale (VAS) was used for the physician's (PhGA) and patient's (PGA) global assessment of disease activity and the patient's assessment of pain. PhGA assessed the patient's current status, PGA assessed status within the last 24 h, and patient's assessment of pain assessed pain status during the last week. All 3 assessments were scored on a 100 mm horizontal scale. The scores range from 0 (no symptoms) to 100 (maximum symptoms); therefore lower VAS scores represent a better disease state. Week 12 = end of Double-Blind period.
Outcome measures
| Measure |
Placebo
n=60 Participants
Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
|
Adalimumab 40 mg
n=120 Participants
Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
|
Adalimumab 80 mg
n=120 Participants
Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
|
|---|---|---|---|
|
Mean Change in Visual Analog Scale (VAS) Score at Week 12 of the Double-Blind Period
PhGA, Week 12
|
-20.6 mm
Standard Deviation 19.1
|
-25.1 mm
Standard Deviation 22.7
|
-20.9 mm
Standard Deviation 19.7
|
|
Mean Change in Visual Analog Scale (VAS) Score at Week 12 of the Double-Blind Period
Pain, Week 12
|
-14.9 mm
Standard Deviation 26
|
-22.7 mm
Standard Deviation 25.2
|
-16.4 mm
Standard Deviation 22.4
|
|
Mean Change in Visual Analog Scale (VAS) Score at Week 12 of the Double-Blind Period
PGA, Week 12
|
-13.8 mm
Standard Deviation 26.2
|
-23.6 mm
Standard Deviation 25.2
|
-16.3 mm
Standard Deviation 25.5
|
SECONDARY outcome
Timeframe: Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92Population: Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.
Visual analog scale (VAS) was used for the physician's (PhGA) and patient's (PGA) global assessment of disease activity and the patient's assessment of pain. PhGA assessed the patient's current status, PGA assessed status within the last 24 h, and patient's assessment of pain assessed pain status during the last week. All 3 assessments were scored on a 100 mm horizontal scale. The scores range from 0 (no symptoms) to 100 (maximum symptoms); therefore lower VAS scores represent a better disease state.
Outcome measures
| Measure |
Placebo
n=294 Participants
Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
|
Adalimumab 40 mg
Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
|
Adalimumab 80 mg
Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
|
|---|---|---|---|
|
Mean Change in Physician's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Week 8 (n = 283)
|
-28.3 mm
Standard Deviation 22.17
|
—
|
—
|
|
Mean Change in Physician's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Week 12 (n = 279)
|
-31.3 mm
Standard Deviation 21.15
|
—
|
—
|
|
Mean Change in Physician's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Week 24 (n = 208)
|
-30.7 mm
Standard Deviation 20.88
|
—
|
—
|
|
Mean Change in Physician's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Week 48 (n = 183)
|
-33.5 mm
Standard Deviation 20.58
|
—
|
—
|
|
Mean Change in Physician's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Week 60 (n = 166)
|
-32.6 mm
Standard Deviation 21.86
|
—
|
—
|
|
Mean Change in Physician's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Week 72 (n = 150)
|
-32.6 mm
Standard Deviation 22.26
|
—
|
—
|
|
Mean Change in Physician's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Baseline
|
60.1 mm
Standard Deviation 16.40
|
—
|
—
|
|
Mean Change in Physician's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Week 0 (n = 293)
|
-22.8 mm
Standard Deviation 20.67
|
—
|
—
|
|
Mean Change in Physician's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Week 4 (n = 289)
|
-25.5 mm
Standard Deviation 21.27
|
—
|
—
|
|
Mean Change in Physician's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Week 36 (n = 200)
|
-33.6 mm
Standard Deviation 21.03
|
—
|
—
|
|
Mean Change in Physician's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Week 84 (n = 137)
|
-33.8 mm
Standard Deviation 20.99
|
—
|
—
|
|
Mean Change in Physician's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Week 92 (n = 130)
|
-35.0 mm
Standard Deviation 19.02
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92Population: Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.
Visual analog scale (VAS) was used for the physician's (PhGA) and patient's (PGA) global assessment of disease activity and the patient's assessment of pain. PhGA assessed the patient's current status, PGA assessed status within the last 24 h, and patient's assessment of pain assessed pain status during the last week. All 3 assessments were scored on a 100 mm horizontal scale. The scores range from 0 (no symptoms) to 100 (maximum symptoms); therefore lower VAS scores represent a better disease state.
Outcome measures
| Measure |
Placebo
n=294 Participants
Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
|
Adalimumab 40 mg
Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
|
Adalimumab 80 mg
Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
|
|---|---|---|---|
|
Mean Change in Patient's Assessment of Pain (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Baseline
|
60.5 mm
Standard Deviation 19.19
|
—
|
—
|
|
Mean Change in Patient's Assessment of Pain (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Week 12 (n = 279)
|
-27.1 mm
Standard Deviation 24.34
|
—
|
—
|
|
Mean Change in Patient's Assessment of Pain (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Week 24 (n = 208)
|
-25.4 mm
Standard Deviation 23.46
|
—
|
—
|
|
Mean Change in Patient's Assessment of Pain (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Week 60 (n = 166)
|
-28.0 mm
Standard Deviation 26.54
|
—
|
—
|
|
Mean Change in Patient's Assessment of Pain (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Week 84 (n = 137)
|
-27.8 mm
Standard Deviation 24.71
|
—
|
—
|
|
Mean Change in Patient's Assessment of Pain (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Week 0 (n = 293)
|
-18.7 mm
Standard Deviation 23.96
|
—
|
—
|
|
Mean Change in Patient's Assessment of Pain (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Week 4 (n = 289)
|
-21.1 mm
Standard Deviation 24.55
|
—
|
—
|
|
Mean Change in Patient's Assessment of Pain (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Week 8 (n = 283)
|
-23.3 mm
Standard Deviation 26.25
|
—
|
—
|
|
Mean Change in Patient's Assessment of Pain (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Week 36 (n = 200)
|
-27.4 mm
Standard Deviation 24.86
|
—
|
—
|
|
Mean Change in Patient's Assessment of Pain (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Week 48 (n = 183)
|
-27.0 mm
Standard Deviation 25.81
|
—
|
—
|
|
Mean Change in Patient's Assessment of Pain (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Week 72 (n = 150)
|
-26.4 mm
Standard Deviation 28.14
|
—
|
—
|
|
Mean Change in Patient's Assessment of Pain (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Week 92 (n = 130)
|
-27.1 mm
Standard Deviation 25.41
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92Population: Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.
Visual analog scale (VAS) was used for the physician's (PhGA) and patient's (PGA) global assessment of disease activity and the patient's assessment of pain. PhGA assessed the patient's current status, PGA assessed status within the last 24 h, and patient's assessment of pain assessed pain status during the last week. All 3 assessments were scored on a 100 mm horizontal scale. The scores range from 0 (no symptoms) to 100 (maximum symptoms); therefore lower VAS scores represent a better disease state.
Outcome measures
| Measure |
Placebo
n=294 Participants
Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
|
Adalimumab 40 mg
Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
|
Adalimumab 80 mg
Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
|
|---|---|---|---|
|
Mean Change in Patient's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Week 24 (n = 208)
|
-26.6 mm
Standard Deviation 25.13
|
—
|
—
|
|
Mean Change in Patient's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Week 36 (n = 200)
|
-29.8 mm
Standard Deviation 25.32
|
—
|
—
|
|
Mean Change in Patient's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Week 48 (n = 183)
|
-30.5 mm
Standard Deviation 26.02
|
—
|
—
|
|
Mean Change in Patient's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Week 60 (n = 166)
|
-28.7 mm
Standard Deviation 28.38
|
—
|
—
|
|
Mean Change in Patient's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Baseline
|
60.7 mm
Standard Deviation 19.61
|
—
|
—
|
|
Mean Change in Patient's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Week 0 (n = 293)
|
-19.0 mm
Standard Deviation 25.18
|
—
|
—
|
|
Mean Change in Patient's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Week 4 (n = 289)
|
-21.0 mm
Standard Deviation 26.19
|
—
|
—
|
|
Mean Change in Patient's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Week 8 (n = 283)
|
-23.6 mm
Standard Deviation 26.88
|
—
|
—
|
|
Mean Change in Patient's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Week 12 (n = 279)
|
-26.3 mm
Standard Deviation 25.79
|
—
|
—
|
|
Mean Change in Patient's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Week 72 (n = 150)
|
-28.7 mm
Standard Deviation 25.98
|
—
|
—
|
|
Mean Change in Patient's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Week 84 (n = 137)
|
-30.5 mm
Standard Deviation 25.62
|
—
|
—
|
|
Mean Change in Patient's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period
Week 92 (n = 130)
|
-29.6 mm
Standard Deviation 25.04
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the double-blind portion of the study), Last Observation Carried Forward (LOCF).
HAQ is a self-reported, subject-oriented outcome measure. The Standard Disability Index of HAQ for a subject is calculated as the mean of the following 8 category scores (range: 0-3): dressing and grooming, rising, eating, walking, hygiene, reach, grip, and activities. The score of each category is calculated as the maximum of the scores for the questions of that category. The Disability Index cannot be computed if the patient does not have scores for at least 6 categories. A decrease in the Disability Index = improvement in disease (0 = no difficulties). Week 12 = end of Double-Blind period.
Outcome measures
| Measure |
Placebo
n=60 Participants
Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
|
Adalimumab 40 mg
n=120 Participants
Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
|
Adalimumab 80 mg
n=120 Participants
Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
|
|---|---|---|---|
|
Mean Change in the Disability Index of the Health Assessment Questionnaire (HAQ) Scores From Baseline to Week 12 of the Double-Blind Period
|
-0.3 score on a scale
Standard Deviation 0.7
|
-0.5 score on a scale
Standard Deviation 0.5
|
-0.4 score on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92Population: Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.
HAQ is a self-reported, subject-oriented outcome measure. The Standard Disability Index of HAQ for a subject is calculated as the mean of the following 8 category scores (range: 0-3): dressing and grooming, rising, eating, walking, hygiene, reach, grip, and activities. The score of each category is calculated as the maximum of the scores for the questions of that category. The Disability Index cannot be computed if the patient does not have scores for at least 6 categories. A decrease in the Disability Index indicates an improvement in disease (0 = no difficulties).
Outcome measures
| Measure |
Placebo
n=294 Participants
Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
|
Adalimumab 40 mg
Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
|
Adalimumab 80 mg
Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
|
|---|---|---|---|
|
Mean Change in the Disability Index of the Health Assessment Questionnaire (HAQ) Through Week 92 of the Open-Label Period
Baseline
|
1.38 score on a scale
Standard Deviation 0.692
|
—
|
—
|
|
Mean Change in the Disability Index of the Health Assessment Questionnaire (HAQ) Through Week 92 of the Open-Label Period
Week 4 (n = 289)
|
-0.51 score on a scale
Standard Deviation 0.584
|
—
|
—
|
|
Mean Change in the Disability Index of the Health Assessment Questionnaire (HAQ) Through Week 92 of the Open-Label Period
Week 8 (n = 283)
|
-0.55 score on a scale
Standard Deviation 0.621
|
—
|
—
|
|
Mean Change in the Disability Index of the Health Assessment Questionnaire (HAQ) Through Week 92 of the Open-Label Period
Week 12 (n = 279)
|
-0.61 score on a scale
Standard Deviation 0.620
|
—
|
—
|
|
Mean Change in the Disability Index of the Health Assessment Questionnaire (HAQ) Through Week 92 of the Open-Label Period
Week 24 (n = 208)
|
-0.56 score on a scale
Standard Deviation 0.617
|
—
|
—
|
|
Mean Change in the Disability Index of the Health Assessment Questionnaire (HAQ) Through Week 92 of the Open-Label Period
Week 48 (n = 183)
|
-0.60 score on a scale
Standard Deviation 0.622
|
—
|
—
|
|
Mean Change in the Disability Index of the Health Assessment Questionnaire (HAQ) Through Week 92 of the Open-Label Period
Week 60 (n = 166)
|
-0.65 score on a scale
Standard Deviation 0.631
|
—
|
—
|
|
Mean Change in the Disability Index of the Health Assessment Questionnaire (HAQ) Through Week 92 of the Open-Label Period
Week 0 (n = 293)
|
-0.42 score on a scale
Standard Deviation 0.575
|
—
|
—
|
|
Mean Change in the Disability Index of the Health Assessment Questionnaire (HAQ) Through Week 92 of the Open-Label Period
Week 36 (n = 200)
|
-0.58 score on a scale
Standard Deviation 0.609
|
—
|
—
|
|
Mean Change in the Disability Index of the Health Assessment Questionnaire (HAQ) Through Week 92 of the Open-Label Period
Week 72 (n = 150)
|
-0.65 score on a scale
Standard Deviation 0.603
|
—
|
—
|
|
Mean Change in the Disability Index of the Health Assessment Questionnaire (HAQ) Through Week 92 of the Open-Label Period
Week 84 (n = 137)
|
-0.63 score on a scale
Standard Deviation 0.590
|
—
|
—
|
|
Mean Change in the Disability Index of the Health Assessment Questionnaire (HAQ) Through Week 92 of the Open-Label Period
Week 92 (n = 130)
|
-0.62 score on a scale
Standard Deviation 0.591
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Double-Blind portion of the study), Observed cases included.
SF-36 (v.2) is a standardized health survey consisting of 36 questions to measure functional health status. The SF-36 score has two components: physical (PCS) and mental (MCS). Summary scores are calculated using the following 8 scales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). An increase in SF-36 PCS or MCS indicates improved health status.
Outcome measures
| Measure |
Placebo
n=59 Participants
Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
|
Adalimumab 40 mg
n=119 Participants
Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
|
Adalimumab 80 mg
n=119 Participants
Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
|
|---|---|---|---|
|
Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) and Mental Component Summary (MCS) at Week 12 of the Double-Blind Period
Physical Component Score, Week 12
|
4.2 score on a scale
Standard Deviation 7.1
|
5.7 score on a scale
Standard Deviation 7.3
|
4.5 score on a scale
Standard Deviation 7.6
|
|
Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) and Mental Component Summary (MCS) at Week 12 of the Double-Blind Period
Mental Component Score, Week 12
|
3.5 score on a scale
Standard Deviation 11.8
|
4.9 score on a scale
Standard Deviation 10.7
|
2.5 score on a scale
Standard Deviation 12.1
|
SECONDARY outcome
Timeframe: Baseline, Week 0, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92Population: Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period). Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.
SF-36 (v.2) is a standardized health survey consisting of 36 questions to measure functional health status. The SF-36 score has two components: physical (PCS) and mental (MCS). Summary scores are calculated using the following 8 scales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). An increase in SF-36 PCS or MCS indicates improved health status.
Outcome measures
| Measure |
Placebo
n=294 Participants
Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
|
Adalimumab 40 mg
Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
|
Adalimumab 80 mg
Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
|
|---|---|---|---|
|
Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 92 of the Open-Label Period
Week 0 (n = 293)
|
5.01 score on a scale
Standard Deviation 7.356
|
—
|
—
|
|
Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 92 of the Open-Label Period
Baseline
|
32.14 score on a scale
Standard Deviation 7.759
|
—
|
—
|
|
Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 92 of the Open-Label Period
Week 12 (n = 283)
|
7.15 score on a scale
Standard Deviation 8.225
|
—
|
—
|
|
Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 92 of the Open-Label Period
Week 24 (n = 208)
|
6.8 score on a scale
Standard Deviation 7.251
|
—
|
—
|
|
Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 92 of the Open-Label Period
Week 36 (n = 200)
|
7.96 score on a scale
Standard Deviation 7.478
|
—
|
—
|
|
Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 92 of the Open-Label Period
Week 48 (n = 183)
|
8.17 score on a scale
Standard Deviation 8.046
|
—
|
—
|
|
Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 92 of the Open-Label Period
Week 60 (n = 166)
|
8.29 score on a scale
Standard Deviation 7.666
|
—
|
—
|
|
Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 92 of the Open-Label Period
Week 72 (n = 150)
|
7.77 score on a scale
Standard Deviation 8.806
|
—
|
—
|
|
Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 92 of the Open-Label Period
Week 84 (n = 137)
|
8.38 score on a scale
Standard Deviation 8.182
|
—
|
—
|
|
Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 92 of the Open-Label Period
Week 92 (n = 130)
|
8.49 score on a scale
Standard Deviation 8.195
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 0, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92Population: Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period). Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.
SF-36 (v.2) is a standardized health survey consisting of 36 questions to measure functional health status. The SF-36 score has two components: physical (PCS) and mental (MCS). Summary scores are calculated using the following 8 scales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). An increase in SF-36 PCS or MCS indicates improved health status.
Outcome measures
| Measure |
Placebo
n=294 Participants
Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
|
Adalimumab 40 mg
Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
|
Adalimumab 80 mg
Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
|
|---|---|---|---|
|
Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 92 of the Open-Label Period
Week 24 (n = 208)
|
5.22 score on a scale
Standard Deviation 11.699
|
—
|
—
|
|
Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 92 of the Open-Label Period
Week 36 (n = 200)
|
5.51 score on a scale
Standard Deviation 11.268
|
—
|
—
|
|
Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 92 of the Open-Label Period
Week 60 (n = 166)
|
5.56 score on a scale
Standard Deviation 10.716
|
—
|
—
|
|
Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 92 of the Open-Label Period
Week 72 (n = 150)
|
4.75 score on a scale
Standard Deviation 10.825
|
—
|
—
|
|
Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 92 of the Open-Label Period
Week 84 (n = 137)
|
5.09 score on a scale
Standard Deviation 11.998
|
—
|
—
|
|
Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 92 of the Open-Label Period
Week 92 (n = 130)
|
4.14 score on a scale
Standard Deviation 11.867
|
—
|
—
|
|
Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 92 of the Open-Label Period
Baseline
|
36.50 score on a scale
Standard Deviation 10.894
|
—
|
—
|
|
Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 92 of the Open-Label Period
Week 0 (n = 293)
|
3.74 score on a scale
Standard Deviation 11.494
|
—
|
—
|
|
Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 92 of the Open-Label Period
Week 12 (n = 283)
|
5.73 score on a scale
Standard Deviation 12.686
|
—
|
—
|
|
Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 92 of the Open-Label Period
Week 48 (n = 183)
|
5.29 score on a scale
Standard Deviation 11.285
|
—
|
—
|
Adverse Events
DB Phase - Placebo EOW
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
DB Phase - Adalimumab 40 mg EOW
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
DB Phase - Adalimumab 80 mg EOW
Serious events: 3 serious events
Other events: 27 other events
Deaths: 0 deaths
Any Adalimumab
Serious events: 23 serious events
Other events: 84 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DB Phase - Placebo EOW
n=60 participants at risk
Placebo administered subcutaneously every other week during Double-Blind treatment.
|
DB Phase - Adalimumab 40 mg EOW
n=121 participants at risk
Adalimumab 40 mg administered subcutaneously every other week during Double-Blind treatment.
|
DB Phase - Adalimumab 80 mg EOW
n=121 participants at risk
Adalimumab 80 mg administered subcutaneously every other week during Double-Blind treatment.
|
Any Adalimumab
n=301 participants at risk
Any adalimumab exposure during the entire study, whether from Double-Blind or Open-Label treatment.
|
|---|---|---|---|---|
|
Nervous system disorders
Cerebral hemorrhage
|
0.00%
0/60 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.83%
1/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.33%
1/301 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/60 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.83%
1/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.33%
1/301 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/60 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.83%
1/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.33%
1/301 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/60 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.83%
1/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.33%
1/301 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/60 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.83%
1/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.33%
1/301 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/60 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.83%
1/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/301 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
|
Blood and lymphatic system disorders
Splenic lesion
|
0.00%
0/60 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.33%
1/301 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/60 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.33%
1/301 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/60 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.66%
2/301 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/60 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.33%
1/301 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
|
Infections and infestations
Appendicitis
|
0.00%
0/60 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.33%
1/301 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
|
Infections and infestations
Disseminated tuberculosis
|
0.00%
0/60 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.66%
2/301 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
|
Infections and infestations
Lymph node tuberculosis
|
0.00%
0/60 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.33%
1/301 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
|
Infections and infestations
Peritoneal tuberculosis
|
0.00%
0/60 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.33%
1/301 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
|
Infections and infestations
Pneumonia
|
0.00%
0/60 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.66%
2/301 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/60 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
1.7%
5/301 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
|
Infections and infestations
Tuberculoma of central nervous system
|
0.00%
0/60 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.33%
1/301 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
|
Infections and infestations
Tuberculous pleurisy
|
0.00%
0/60 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.66%
2/301 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/60 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.33%
1/301 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/60 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.33%
1/301 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/60 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.33%
1/301 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/60 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.33%
1/301 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/60 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.33%
1/301 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/60 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.33%
1/301 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/60 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.33%
1/301 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal disorder
|
0.00%
0/60 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.33%
1/301 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/60 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.66%
2/301 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hilar enlargement
|
0.00%
0/60 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.33%
1/301 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/60 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.33%
1/301 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/60 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.33%
1/301 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
Other adverse events
| Measure |
DB Phase - Placebo EOW
n=60 participants at risk
Placebo administered subcutaneously every other week during Double-Blind treatment.
|
DB Phase - Adalimumab 40 mg EOW
n=121 participants at risk
Adalimumab 40 mg administered subcutaneously every other week during Double-Blind treatment.
|
DB Phase - Adalimumab 80 mg EOW
n=121 participants at risk
Adalimumab 80 mg administered subcutaneously every other week during Double-Blind treatment.
|
Any Adalimumab
n=301 participants at risk
Any adalimumab exposure during the entire study, whether from Double-Blind or Open-Label treatment.
|
|---|---|---|---|---|
|
General disorders
Injection site pruritus
|
0.00%
0/60 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
5.8%
7/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
4.1%
5/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
0.00%
0/301 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
4/60 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
5.8%
7/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
7.4%
9/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
10.6%
32/301 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
|
Infections and infestations
Upper respiratory tract infection
|
11.7%
7/60 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
14.0%
17/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
12.4%
15/121 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
19.9%
60/301 • The duration for adverse event reporting was 92 weeks. Data from the Double-Blind period (Week 0 through Week 12) and from any adalimumab exposure (Week 0 through Week 92) were reported.
AEs were recorded from the first day of Adalimumab (ADA) treatment through 70 days after the last dose of ADA. \*\*A placebo participant during the DB period was not included in this group, as this participant discontinued from the study prior to the OL period, thus having no ADA exposure (AEs were recorded for 301 out of 302 enrolled subjects).\*\*
|
Additional Information
Global Medical Services
Abbott
Phone: 800-633-9110
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Restriction type: OTHER