Trial Outcomes & Findings for Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Active Ulcerative Colitis (NCT NCT00408629)
NCT ID: NCT00408629
Last Updated: 2011-05-03
Results Overview
Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores: Stool Frequency Subscore (SFS), Rectal Bleeding Subscore (RBS), Endoscopy Subscore, and Physician's Global Assessment Subscore (PGA), each of which ranges from 0 (normal) to 3 (severe disease).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
518 participants
Primary outcome timeframe
Week 8
Results posted on
2011-05-03
Participant Flow
Participant milestones
| Measure |
Adalimumab 160/80/40
During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
|
Placebo
The placebo treatment group received placebo throughout the Double-Blind (DB) period.
|
|---|---|---|
|
Overall Study
STARTED
|
258
|
260
|
|
Overall Study
COMPLETED
|
161
|
135
|
|
Overall Study
NOT COMPLETED
|
97
|
125
|
Reasons for withdrawal
| Measure |
Adalimumab 160/80/40
During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
|
Placebo
The placebo treatment group received placebo throughout the Double-Blind (DB) period.
|
|---|---|---|
|
Overall Study
Adverse Event
|
13
|
27
|
|
Overall Study
Withdrawal by Subject
|
8
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
63
|
73
|
|
Overall Study
Protocol Violation
|
1
|
5
|
|
Overall Study
Miscellaneous
|
11
|
15
|
Baseline Characteristics
Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Active Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
Adalimumab 160/80/40
n=248 Participants
During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
|
Placebo
n=246 Participants
The placebo treatment group received placebo throughout the Double-Blind (DB) period.
|
Total
n=494 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
39.6 Years
STANDARD_DEVIATION 12.47 • n=99 Participants
|
41.3 Years
STANDARD_DEVIATION 13.22 • n=107 Participants
|
40.4 Years
STANDARD_DEVIATION 12.86 • n=206 Participants
|
|
Age, Customized
< 40 years
|
136 Participants
n=99 Participants
|
118 Participants
n=107 Participants
|
254 Participants
n=206 Participants
|
|
Age, Customized
40 to 64 years
|
105 Participants
n=99 Participants
|
116 Participants
n=107 Participants
|
221 Participants
n=206 Participants
|
|
Age, Customized
>=65 years
|
7 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
106 Participants
n=99 Participants
|
94 Participants
n=107 Participants
|
200 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
142 Participants
n=99 Participants
|
152 Participants
n=107 Participants
|
294 Participants
n=206 Participants
|
|
Region of Enrollment
Portugal
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
78 Participants
n=99 Participants
|
82 Participants
n=107 Participants
|
160 Participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Region of Enrollment
Austria
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Region of Enrollment
Israel
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
France
|
18 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Region of Enrollment
Czech Republic
|
18 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Region of Enrollment
Hungary
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
18 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Region of Enrollment
Poland
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Region of Enrollment
Belgium
|
26 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Region of Enrollment
Australia
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Region of Enrollment
Denmark
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
Norway
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
19 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Region of Enrollment
New Zealand
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Region of Enrollment
Switzerland
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: Intent-to-treat (ITT) analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label (OL) treatment were considered to be non-remission.
Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores: Stool Frequency Subscore (SFS), Rectal Bleeding Subscore (RBS), Endoscopy Subscore, and Physician's Global Assessment Subscore (PGA), each of which ranges from 0 (normal) to 3 (severe disease).
Outcome measures
| Measure |
Adalimumab 160/80/40
n=248 Participants
During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
|
Placebo
n=246 Participants
The placebo treatment group received placebo throughout the Double-Blind (DB) period.
|
|---|---|---|
|
Proportion of Participants Who Achieved Clinical Remission Per Mayo Score at Week 8
|
16.5 Percentage of Participants
|
9.3 Percentage of Participants
|
PRIMARY outcome
Timeframe: Week 52Population: Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to OL treatment were considered to be non-remission.
Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores: SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease).
Outcome measures
| Measure |
Adalimumab 160/80/40
n=248 Participants
During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
|
Placebo
n=246 Participants
The placebo treatment group received placebo throughout the Double-Blind (DB) period.
|
|---|---|---|
|
Proportion of Participants Who Achieved Clinical Remission Per Mayo Score at Week 52
|
17.3 Percentage of Participants
|
8.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 8, Week 52Population: Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.
Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores: SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease).
Outcome measures
| Measure |
Adalimumab 160/80/40
n=248 Participants
During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
|
Placebo
n=246 Participants
The placebo treatment group received placebo throughout the Double-Blind (DB) period.
|
|---|---|---|
|
Proportion of Participants Who Achieved Sustained Clinical Remission Per Mayo Score at Both Week 8 and Week 52
|
8.5 Percentage of Participants
|
4.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 8Population: Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.
Clinical response per Mayo score is defined as a decrease in Mayo score of at least 3 points and at least 30% from Baseline, plus either a decrease in rectal bleeding subscore (RBS) of at least 1 point from Baseline or an absolute RBS of 0 or 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores: SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease).
Outcome measures
| Measure |
Adalimumab 160/80/40
n=248 Participants
During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
|
Placebo
n=246 Participants
The placebo treatment group received placebo throughout the Double-Blind (DB) period.
|
|---|---|---|
|
Proportion of Participants Who Achieved Clinical Response Per Mayo Score at Week 8
|
50.4 Percentage of Participants
|
34.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 52Population: Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.
Clinical response per Mayo score is defined as a decrease in Mayo score of at least 3 points and at least 30% from Baseline, plus either a decrease in RBS of at least 1 point from Baseline or an absolute RBS of 0 or 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores: SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease).
Outcome measures
| Measure |
Adalimumab 160/80/40
n=248 Participants
During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
|
Placebo
n=246 Participants
The placebo treatment group received placebo throughout the Double-Blind (DB) period.
|
|---|---|---|
|
Proportion of Participants Who Achieved Clinical Response Per Mayo Score at Week 52
|
30.2 Percentage of Participants
|
18.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 8, Week 52Population: Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.
Clinical response per Mayo score is defined as a decrease in Mayo score of at least 3 points and at least 30% from Baseline, plus either a decrease in RBS of at least 1 point from Baseline or an absolute RBS of 0 or 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores: SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease).
Outcome measures
| Measure |
Adalimumab 160/80/40
n=248 Participants
During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
|
Placebo
n=246 Participants
The placebo treatment group received placebo throughout the Double-Blind (DB) period.
|
|---|---|---|
|
Proportion of Participants Who Achieved Sustained Clinical Response Per Mayo Score at Both Week 8 and Week 52
|
23.8 Percentage of Participants
|
12.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 8Population: Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.
Mucosal healing is defined as an Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows: 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease(spontaneous bleeding, ulceration).
Outcome measures
| Measure |
Adalimumab 160/80/40
n=248 Participants
During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
|
Placebo
n=246 Participants
The placebo treatment group received placebo throughout the Double-Blind (DB) period.
|
|---|---|---|
|
Proportion of Participants Who Achieved Mucosal Healing at Week 8
|
41.1 Percentage of Participants
|
31.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 52Population: Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.
Mucosal healing is defined as an Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows: 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease(spontaneous bleeding, ulceration).
Outcome measures
| Measure |
Adalimumab 160/80/40
n=248 Participants
During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
|
Placebo
n=246 Participants
The placebo treatment group received placebo throughout the Double-Blind (DB) period.
|
|---|---|---|
|
Proportion of Participants Who Achieved Mucosal Healing at Week 52
|
25.0 Percentage of Participants
|
15.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 8, Week 52Population: Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.
Mucosal healing is defined as an Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows: 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease(spontaneous bleeding, ulceration).
Outcome measures
| Measure |
Adalimumab 160/80/40
n=248 Participants
During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
|
Placebo
n=246 Participants
The placebo treatment group received placebo throughout the Double-Blind (DB) period.
|
|---|---|---|
|
Proportion of Participants Who Achieved Sustained Mucosal Healing at Both Week 8 and Week 52
|
18.5 Percentage of Participants
|
10.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.
Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores: SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease).
Outcome measures
| Measure |
Adalimumab 160/80/40
n=150 Participants
During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
|
Placebo
n=140 Participants
The placebo treatment group received placebo throughout the Double-Blind (DB) period.
|
|---|---|---|
|
Proportion of Participants Who Discontinued Corticosteroid Use Before Week 52 and Achieved Clinical Remission Per Mayo Score at Week 52
|
13.3 Percentage of Participants
|
5.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 8Population: Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.
The PGA includes the 3 other subscores (SFS, RBS, and Endoscopy), the participant's daily record of abdominal discomfort and functional assessment, and other observations such as physical findings and the participant's performance status. Possible scores range from 0-3 as follows: 0 = Normal (other subscores are 0), 1 = Mild disease (other subscores are mostly 1), 2 = Moderate disease (other subscores are 1 to 2), 3 = Severe disease (other subscores are 2 to 3).
Outcome measures
| Measure |
Adalimumab 160/80/40
n=248 Participants
During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
|
Placebo
n=246 Participants
The placebo treatment group received placebo throughout the Double-Blind (DB) period.
|
|---|---|---|
|
Proportion of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8
|
46.0 Percentage of Participants
|
37.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 8Population: Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.
SFS ranges from 0-3 as follows: 0 = Normal number of stools for this participant, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal. The participant served as his/her own control.
Outcome measures
| Measure |
Adalimumab 160/80/40
n=248 Participants
During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
|
Placebo
n=246 Participants
The placebo treatment group received placebo throughout the Double-Blind (DB) period.
|
|---|---|---|
|
Proportion of Participants With Stool Frequency Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8
|
37.9 Percentage of Participants
|
28.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 8Population: Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.
RBS ranges from 0-3 as follows: 0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, 3 = blood alone passed
Outcome measures
| Measure |
Adalimumab 160/80/40
n=248 Participants
During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
|
Placebo
n=246 Participants
The placebo treatment group received placebo throughout the Double-Blind (DB) period.
|
|---|---|---|
|
Proportion of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8
|
70.2 Percentage of Participants
|
58.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.
Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores: SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease).
Outcome measures
| Measure |
Adalimumab 160/80/40
n=150 Participants
During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
|
Placebo
n=140 Participants
The placebo treatment group received placebo throughout the Double-Blind (DB) period.
|
|---|---|---|
|
Proportion of Participants Who Discontinued Corticosteroid Use for At Least 90 Days and Achieved Clinical Remission Per Mayo Score at Week 52
|
13.3 Percentage of Participants
|
5.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 32, Week 52Population: Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.
Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores: SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease).
Outcome measures
| Measure |
Adalimumab 160/80/40
n=150 Participants
During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
|
Placebo
n=140 Participants
The placebo treatment group received placebo throughout the Double-Blind (DB) period.
|
|---|---|---|
|
Proportion of Participants Who Discontinued Corticosteroid Use and Achieved Clinical Remission Per Mayo Score (Sustained) at Both Weeks 32 and 52
|
10.0 Percentage of Participants
|
1.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 52Population: Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.
Response per the Inflammatory Bowel Disease Questionnaire (IBDQ) was defined as at least a 16-point increase from Baseline in total IBDQ score. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function, and emotional status. The responses to questions within each domain range from 1 (significant impairment) to 7 (no impairment), with total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).
Outcome measures
| Measure |
Adalimumab 160/80/40
n=248 Participants
During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
|
Placebo
n=246 Participants
The placebo treatment group received placebo throughout the Double-Blind (DB) period.
|
|---|---|---|
|
Proportion of Inflammatory Bowel Disease Questionnaire Responders at Week 52
|
26.2 Percentage of Participants
|
16.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 8Population: Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.
Response per the Inflammatory Bowel Disease Questionnaire (IBDQ) was defined as at least a 16-point increase from Baseline in total IBDQ score. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function, and emotional status. The responses to questions within each domain range from 1 (significant impairment) to 7 (no impairment), with total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).
Outcome measures
| Measure |
Adalimumab 160/80/40
n=248 Participants
During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
|
Placebo
n=246 Participants
The placebo treatment group received placebo throughout the Double-Blind (DB) period.
|
|---|---|---|
|
Proportion of Inflammatory Bowel Disease Questionnaire Responders at Week 8
|
58.1 Percentage of Participants
|
45.5 Percentage of Participants
|
Adverse Events
Adalimumab Group - Double-Blind Period
Serious events: 31 serious events
Other events: 139 other events
Deaths: 0 deaths
Placebo Group - Double-Blind Period
Serious events: 32 serious events
Other events: 142 other events
Deaths: 0 deaths
Any Adalimumab
Serious events: 61 serious events
Other events: 204 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adalimumab Group - Double-Blind Period
n=257 participants at risk
During the Double-Blind period, the Adalimumab treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
|
Placebo Group - Double-Blind Period
n=260 participants at risk
The placebo treatment group received placebo throughout the Double-Blind period.
|
Any Adalimumab
n=398 participants at risk
During the Double-Blind period, only the Adalimumab treatment group received active study drug (dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 \[160/80/40 mg\]). After the switch to open-label treatment, participants in both treatment groups received adalimumab 40 mg eow, unless they dose-escalated, in which case they received adalimumab 40 mg every week (ew). Consequently, this analysis set combined adalimumab exposure from both the Double-Blind and Open-Label periods.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.78%
2/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.38%
1/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.75%
3/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.39%
1/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.25%
1/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Gastrointestinal disorders
Abdominal pain
|
0.39%
1/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.50%
2/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.39%
1/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.25%
1/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.38%
1/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Gastrointestinal disorders
Colitis
|
0.39%
1/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.25%
1/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Gastrointestinal disorders
Colitis ulcerative
|
6.2%
16/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
6.9%
18/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
8.8%
35/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Gastrointestinal disorders
Constipation
|
0.39%
1/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.25%
1/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Gastrointestinal disorders
Gastrointestinal dysplasia
|
0.39%
1/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.25%
1/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.25%
1/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.50%
2/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.39%
1/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.25%
1/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Gastrointestinal disorders
Localized intraabdominal fluid collection
|
0.39%
1/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.25%
1/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.39%
1/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.25%
1/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.38%
1/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.39%
1/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.25%
1/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Gastrointestinal disorders
Rectal perforation
|
0.00%
0/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.38%
1/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.38%
1/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.25%
1/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.39%
1/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.25%
1/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Infections and infestations
Anal abscess
|
0.39%
1/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.38%
1/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.25%
1/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Infections and infestations
Appendicitis
|
0.39%
1/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.50%
2/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Infections and infestations
Catheter sepsis
|
0.39%
1/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.25%
1/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.00%
0/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.38%
1/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.25%
1/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Infections and infestations
Erysipelas
|
0.00%
0/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.25%
1/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.25%
1/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Infections and infestations
Liver abscess
|
0.00%
0/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.38%
1/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Infections and infestations
Perineal abscess
|
0.00%
0/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.38%
1/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Infections and infestations
Pneumonia
|
0.00%
0/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.38%
1/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Infections and infestations
Pneumonia necrotizing
|
0.00%
0/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.38%
1/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.25%
1/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Infections and infestations
Salmonellosis
|
0.39%
1/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.25%
1/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Infections and infestations
Scrotal abscess
|
0.00%
0/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.38%
1/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.39%
1/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.25%
1/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Injury, poisoning and procedural complications
Wound
|
0.39%
1/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.25%
1/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.25%
1/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.25%
1/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.25%
1/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Musculoskeletal and connective tissue disorders
Ligament calcification
|
0.00%
0/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.38%
1/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.25%
1/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.39%
1/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.25%
1/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
0.39%
1/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.25%
1/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Pregnancy, puerperium and perinatal conditions
Abortion
|
0.00%
0/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.25%
1/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Renal and urinary disorders
Calculus ureteric
|
0.39%
1/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.38%
1/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.25%
1/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.39%
1/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.25%
1/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.25%
1/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.38%
1/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.25%
1/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Respiratory, thoracic and mediastinal disorders
Organizing pneumonia
|
0.00%
0/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.38%
1/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.38%
1/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.25%
1/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.39%
1/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.25%
1/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.39%
1/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.38%
1/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.25%
1/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Skin and subcutaneous tissue disorders
Pyoderma gangrenosum
|
0.00%
0/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
1.5%
4/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Vascular disorders
Deep vein thrombosis
|
0.78%
2/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.38%
1/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.50%
2/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.38%
1/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.38%
1/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
Other adverse events
| Measure |
Adalimumab Group - Double-Blind Period
n=257 participants at risk
During the Double-Blind period, the Adalimumab treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
|
Placebo Group - Double-Blind Period
n=260 participants at risk
The placebo treatment group received placebo throughout the Double-Blind period.
|
Any Adalimumab
n=398 participants at risk
During the Double-Blind period, only the Adalimumab treatment group received active study drug (dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 \[160/80/40 mg\]). After the switch to open-label treatment, participants in both treatment groups received adalimumab 40 mg eow, unless they dose-escalated, in which case they received adalimumab 40 mg every week (ew). Consequently, this analysis set combined adalimumab exposure from both the Double-Blind and Open-Label periods.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.1%
8/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
5.4%
14/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
5.3%
21/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Gastrointestinal disorders
Abdominal pain
|
7.4%
19/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
6.2%
16/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
6.8%
27/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Gastrointestinal disorders
Colitis ulcerative
|
16.3%
42/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
22.3%
58/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
17.8%
71/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Gastrointestinal disorders
Nausea
|
5.8%
15/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
8.5%
22/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
5.8%
23/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
General disorders
Fatigue
|
6.2%
16/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
5.8%
15/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
6.3%
25/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
General disorders
Pyrexia
|
4.3%
11/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
5.4%
14/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
5.8%
23/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Infections and infestations
Nasopharyngitis
|
17.5%
45/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
10.4%
27/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
17.1%
68/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Infections and infestations
Upper respiratory tract infection
|
4.3%
11/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
5.4%
14/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
0.00%
0/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.8%
20/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
6.2%
16/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
7.5%
30/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Nervous system disorders
Headache
|
8.6%
22/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
14.2%
37/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
7.8%
31/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.8%
15/257 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
2.7%
7/260 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
5.8%
23/398 • Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
\*\*518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.\*\*
|
Additional Information
Global Medical Services
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Results disclosure agreements
- Principal investigator is a sponsor employee Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER