Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001682-16 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate safety and efficacy of two adalimumab dosing regimens for induction and maintenance (standard and higher dosing) in achieving clinical remission in subjects with moderately to severely active ulcerative colitis.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induction (Main Study + Japan Sub-study): I-SD | Experimental | Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6. |
|
| Induction (Main Study + Japan Sub-study): I-HD | Experimental | Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4, and 40 mg at Week 6. |
|
| Maintenance (Main Study + Japan Sub-study): M-SD | Experimental | Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks. |
|
| Maintenance (Main Study + Japan Sub-study): M-HD | Experimental | Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks. |
|
| Maintenance (Main Study): TDM Regimen | Experimental | Double-blind adalimumab 40 mg eow at Week 8 and Week 10, with possible dose adjustments at Weeks 12, 24, and 37 based on criteria assessing blinded adalimumab serum concentration and rectal bleeding subscore (RBS) assessments. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Induction Period Primary Endpoint: Percentage of Participants With Clinical Remission Per Full Mayo Score (FMS) at Week 8 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore > 1. | Week 8 |
| Maintenance Period Primary Endpoint: Percentage of Week 8 Responders (Per FMS) With Clinical Remission (Per FMS) at Week 52 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders (per FMS) are defined as participants with a decrease in Full Mayo score of ≥ 3 points and ≥ 30% from Baseline plus a decrease from baseline in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore > 1. | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Induction Period Ranked Secondary Endpoint 1: Percentage of Participants With Endoscopic Improvement at Week 8 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Endoscopic improvement is defined as an endoscopy subscore of 0 or 1. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Digestive Health Specialists of the Southeast /ID# 127844 | Dothan | Alabama | 36305 | United States | ||
| Ucsd /Id# 122313 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39162746 | Derived | Reppell M, Zheng X, Dreher I, Blaes J, Regan E, Haslberger T, Guay H, Pivorunas V, Smaoui N. HLA-DQA1*05 Associates With Anti-Tumor Necrosis Factor Immunogenicity and Low Adalimumab Trough Concentrations in Inflammatory Bowel Disease Patients From the SERENE Ulcerative Colitis and Crohn's Disease Studies. J Crohns Colitis. 2025 Jan 11;19(1):jjae129. doi: 10.1093/ecco-jcc/jjae129. | |
| 37801628 |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
At Week 8, participants in Main Study were re-randomized (2:2:1) into 44-week DB Maintenance Period with 3 adalimumab dosing regimens (M-SD, M-HD, or an exploratory Therapeutic Drug Monitoring [TDM] Regimen). Participants in Japan Sub-study were re-randomized (1:1) into 44-week DB Maintenance Period with 2 adalimumab dosing regimens (M-SD, M-HD).
This study included a Main Study (120 sites in 19 countries) and a Japan Sub-Study (22 sites in Japan).
After a 3-week screening period, participants were randomized 3:2 to an 8-week double-blind (DB) Induction Period with 2 adalimumab dosing regimens (Induction Standard Dose [I-SD] or Induction Higher Dose [I-HD]).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Induction (Main Study + Japan Sub-study): I-SD | Induction Standard Dose (I-SD): Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6. |
| FG001 | Induction (Main Study + Japan Sub-study): I-HD |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Induction Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 13, 2019 | Sep 9, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Placebo | Other |
|
| Week 8 |
| Induction Period Ranked Secondary Endpoint 2: Percentage of Participants With Fecal Calprotectin < 150 mg/kg at Week 8 | Week 8 |
| Induction Period Ranked Secondary Endpoint 3: Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Response (Increase of IBDQ ≥ 16 From Baseline) at Week 8 | The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Total IBDQ score is the sum of the responses to the individual IBDQ questions, and ranges from 32 to 224 with higher scores indicating a better quality of life. | Week 8 |
| Induction Period Ranked Secondary Endpoint 4: Percentage of Participants With Clinical Response Per FMS at Week 8 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical response is defined as a decrease in FMS of ≥ 3 points and ≥ 30% from baseline, plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. | Week 8 |
| Induction Period Ranked Secondary Endpoint 5: Percentage of Participants With Endoscopic Remission at Week 8 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Endoscopic remission is defined as an endoscopy subscore of 0. | Week 8 |
| Induction Period Ranked Secondary Endpoint 6: Percentage of Participants Achieving Response in IBDQ Bowel Symptom Domain at Week 8 | The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). The range for Bowel Symptom domain score is 10 (severe problem) to 70 (normal health). Response in IBDQ Bowel Symptom domain is defined as an increase of IBDQ Bowel Symptom domain score ≥ 6. | Week 8 |
| Induction Period Ranked Secondary Endpoint 7: Percentage of Participants Achieving Response in IBDQ Fatigue Item at Week 8 | The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). The IBDQ Fatigue item score range is from 1 (severe problem) to 7 (normal health). Response is defined as an increase of IBDQ Fatigue item score ≥ 1. | Week 8 |
| Maintenance Period Ranked Secondary Endpoint 1: Percentage of Week 8 Responders (Per FMS) With Endoscopic Improvement at Week 52 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. Endoscopic improvement is defined as an endoscopy subscore of 0 or 1. | Week 52 |
| Maintenance Period Ranked Secondary Endpoint 2: Percentage of Week 8 Responders With Steroid Usage at Baseline and Steroid Free at Least 90 Days at Week 52 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders, per FMS, are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. | Week 52 |
| Maintenance Period Ranked Secondary Endpoint 3: Percentage of Week 8 Responders With Steroid Usage at Baseline and Steroid Free at Least 90 Days and With Clinical Remission at Week 52 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders, per FMS, are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. Clinical remission is defined as FMS ≤ 2 with no subscore > 1. | Week 52 |
| Maintenance Period Ranked Secondary Endpoint 4: Percentage of Week 8 Remitters (Per FMS) With Clinical Remission (Per FMS) at Week 52 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1. Endoscopy subscore provided by the central reader. | Week 52 |
| Maintenance Period Ranked Secondary Endpoint 5: Percentage of Week 8 Remitters (Per FMS) With Endoscopic Improvement at Week 52 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1. Endoscopic improvement is defined as an endoscopy subscore of 0 or 1. Endoscopy subscore provided by the central reader. | Week 52 |
| Maintenance Period Ranked Secondary Endpoint 6: Percentage of Week 8 Remitters (Per FMS) With Steroid Usage at Baseline and Steroid Free at Least 90 Days at Week 52 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1. | Week 52 |
| Maintenance Period Ranked Secondary Endpoint 7: Percentage of Week 8 Remitters (Per FMS) With Steroid Usage at Baseline and Steroid Free at Least 90 Days and With Clinical Remission (Per FMS) at Week 52 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1. | Week 52 |
| Maintenance Period Ranked Secondary Endpoint 8: Percentage of Week 8 Responders (Per FMS) With IBDQ Response (Increase of IBDQ ≥ 16 From Baseline) at Week 52 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Total IBDQ score is the sum of responses to the individual IBDQ questions, and ranges from 32 to 224 with higher scores indicating a better quality of life. | Week 52 |
| Maintenance Period Ranked Secondary Endpoint 9: Percentage of Week 8 Non-Responders With Clinical Remission (Per FMS) at Week 52 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 non-responders are defined as participants not meeting the criteria of response (defined as a decrease in FMS of ≥ 3 points and ≥ 30% from baseline, plus a decrease in the rectal bleeding subscore [RBS] ≥ 1 or an absolute RBS ≤ 1) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1. | Week 52 |
| Maintenance Period Ranked Secondary Endpoint 10: Percentage of Week 8 Non-Remitters With Clinical Remission (Per FMS) at Week 52 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 non-remitters are defined as participants not meeting the criteria of clinical remission at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1. | Week 52 |
| Maintenance Period Ranked Secondary Endpoint 11: Percentage of Week 8 Responders (Per FMS) With Endoscopic Subscore of 0 at Week 52 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders (per Full Mayo score) are defined as participants with a decrease in Full Mayo score of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. Endoscopic remission is defined as an endoscopy subscore of 0. | Week 52 |
| Maintenance Period Ranked Secondary Endpoint 12: Percentage of Week 8 Remitters (Per FMS) With Endoscopic Subscore of 0 at Week 52 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1. Endoscopic remission is defined as an endoscopy subscore of 0. | Week 52 |
| Maintenance Period Ranked Secondary Endpoint 13: Percentage of Week 8 Responders (Per FMS) With Response in IBDQ Bowel Symptom Domain at Week 52 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore [RBS] ≥ 1 or an absolute RBS ≤ 1. The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Bowel Symptom domain score range is 10 (severe problem) to 70 (normal health). Response is defined as increase of Bowel Symptom domain score ≥ 6 from baseline. | Week 52 |
| Maintenance Period Ranked Secondary Endpoint 14: Percentage of Week 8 Responders (Per FMS) With Response in IBDQ Fatigue Item at Week 52 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Response in IBDQ fatigue item (range 1 [severe problem] to 7 [normal health]) is defined as increase of IBDQ fatigue item ≥ 1 from baseline. | Week 52 |
| La Jolla |
| California |
| 92093 |
| United States |
| Rocky Mountain Clinical Resear /ID# 122180 | Wheat Ridge | Colorado | 80033 | United States |
| Medical Research Ctr CT /ID# 122179 | Hamden | Connecticut | 06518 | United States |
| Gastro Florida /ID# 170619 | Clearwater | Florida | 33756 | United States |
| Research Associates of South Florida,LLC /ID# 170309 | Miami | Florida | 33156 | United States |
| Gastroenterology Group Naples /ID# 127806 | Naples | Florida | 34102 | United States |
| Shafran Gastroenterology Ctr /ID# 122320 | Winter Park | Florida | 32789 | United States |
| Atlanta Gastro Assoc /ID# 122336 | Atlanta | Georgia | 30342 | United States |
| Gastro Assoc of Central GA /ID# 122318 | Macon | Georgia | 31201 | United States |
| Northwestern University Feinberg School of Medicine /ID# 122183 | Chicago | Illinois | 60611-2927 | United States |
| University of Chicago /ID# 122302 | Chicago | Illinois | 60637-1443 | United States |
| Carle Foundation Hospital /ID# 135955 | Urbana | Illinois | 61801 | United States |
| Louisiana Research Ctr. LLC /ID# 141655 | Shreveport | Louisiana | 71105-6800 | United States |
| University of Maryland Med Ctr /ID# 169734 | Baltimore | Maryland | 21201 | United States |
| MGG Group, Inc.Chevy Chase Clinical Research /ID# 122238 | Chevy Chase | Maryland | 20815 | United States |
| University of Michigan Hospitals /ID# 122240 | Ann Arbor | Michigan | 48109 | United States |
| Mayo Clinic - Rochester /ID# 122244 | Rochester | Minnesota | 55905-0001 | United States |
| Ctr for Digest and Liver Dis /ID# 122182 | Mexico | Missouri | 65265 | United States |
| NYU Langone Long Island CRA /ID# 122177 | Great Neck | New York | 11021 | United States |
| Icahn School of Med Mt. Sinai /ID# 127047 | New York | New York | 10029 | United States |
| Charlotte Gastro Hepatology /ID# 122235 | Charlotte | North Carolina | 28207 | United States |
| Wake Research Associates, LLC /ID# 122157 | Raleigh | North Carolina | 27612 | United States |
| Consultants for Clinical Res /ID# 122304 | Cincinnati | Ohio | 45219 | United States |
| Dayton Gastroenterology, Inc. /ID# 127804 | Englewood | Ohio | 45415 | United States |
| Gastro United of Tulsa /ID# 125436 | Tulsa | Oklahoma | 74135 | United States |
| The Oregon Clinic- Gastro West /ID# 135273 | Portland | Oregon | 97225 | United States |
| University of Pittsburgh MC /ID# 122331 | Pittsburgh | Pennsylvania | 15260 | United States |
| Erlanger Institute for Clinica /ID# 129009 | Chattanooga | Tennessee | 37403 | United States |
| Gastro One /ID# 122339 | Germantown | Tennessee | 38138 | United States |
| Vanderbilt Univ Med Ctr /ID# 125496 | Nashville | Tennessee | 37232-0011 | United States |
| DHAT Research Institute /ID# 170616 | Garland | Texas | 75044-2208 | United States |
| Biopharma Informatic Research /ID# 171150 | Houston | Texas | 77024-2420 | United States |
| Austin Center for Clinical Research /ID# 125396 | Pflugerville | Texas | 78660 | United States |
| Texas Digestive Disease Consul /ID# 141677 | Southlake | Texas | 76092 | United States |
| Texas Digestive Disease Consul /ID# 141678 | Southlake | Texas | 76092 | United States |
| Advanced Research Institute /ID# 126147 | Ogden | Utah | 84403 | United States |
| University of Utah /ID# 122333 | Salt Lake City | Utah | 84112-5500 | United States |
| New River Valley Research Inst /ID# 127801 | Christiansburg | Virginia | 24073 | United States |
| University of Washington /ID# 169721 | Seattle | Washington | 98109 | United States |
| WI Center for Advanced Res /ID# 122178 | Milwaukee | Wisconsin | 53215 | United States |
| Froedtert & the Medical College of Wisconsin /ID# 122261 | Milwaukee | Wisconsin | 53226-3522 | United States |
| Medizinische Universitat Wien /ID# 127186 | Vienna | State of Vienna | 1090 | Austria |
| KH der Elisabethinen Linz GmbH /ID# 127184 | Linz | Upper Austria | 4010 | Austria |
| Ordination Hainburg an der Don /ID# 127185 | Hainburg an der Donau | 2410 | Austria |
| Universitaetsklinik fuer Innere Medizin 1 /ID# 125944 | Salzburg | 5020 | Austria |
| KH der Barmherzigen Brueder /ID# 127183 | Sankt Veit an der Glan | 9300 | Austria |
| AZ Sint-Lucas /ID# 127187 | Ghent | 9000 | Belgium |
| UZ Leuven /ID# 126739 | Leuven | 3000 | Belgium |
| CHU de Liege /ID# 126740 | Liège | 4000 | Belgium |
| University of Calgary /ID# 125715 | Calgary | Alberta | T2N 4Z6 | Canada |
| Zeidler Ledcor Centre /ID# 125713 | Edmonton | Alberta | T6G 2X8 | Canada |
| Winnipeg Regional Health Autho /ID# 125712 | Winnipeg | Manitoba | R3A 1R9 | Canada |
| Qe Ii Hsc /Id# 127045 | Halifax | Nova Scotia | B3H 1V7 | Canada |
| London Health Sciences Centre /ID# 127055 | London | Ontario | N6A 5A5 | Canada |
| Mount Sinai Hosp.-Toronto /ID# 126590 | Toronto | Ontario | M5G 1X5 | Canada |
| Toronto Digestive Disease Asso /ID# 127075 | Vaughan | Ontario | L4L 4Y7 | Canada |
| McGill Univ HC /ID# 127046 | Montreal | Quebec | H3G 1A4 | Canada |
| Hepato-Gastroenterologie HK s.r.o. /ID# 127188 | Hradec Králové | 500 12 | Czechia |
| ISCARE a.s. /ID# 127837 | Prague | 190 00 | Czechia |
| Herlev Hospital /ID# 127191 | Herlev | Capital Region | 2730 | Denmark |
| Regionhospital Silkeborg /ID# 127190 | Silkeborg | 8600 | Denmark |
| CHRU Lille - Hôpital Claude Huriez /ID# 127197 | Lille | Hauts-de-France | 59045 | France |
| CHU NANCY - Hôpital Brabois Adultes /ID# 127196 | Vandœuvre-lès-Nancy | Meurthe-et-Moselle | 54511 | France |
| CHU Amiens Picardie /ID# 127194 | Amiens | Somme | 80054 | France |
| CHU Estaing /ID# 127848 | Clermont-Ferrand | 63100 | France |
| CHU Dijon /ID# 127861 | Dijon | 21000 | France |
| CHU de Grenoble - Albet Michal /ID# 127195 | Grenoble | 38043 | France |
| CHU Saint ELOI /ID# 169007 | Montpellier | 34295 | France |
| CHU de Nice /ID# 127193 | Nice | 06202 | France |
| CHU de Saint-Etienne, Hopital Nord /ID# 134490 | Saint-Etienne | 42270 | France |
| Hopital Rangueil /ID# 127192 | Toulouse | 31059 | France |
| Universitatsklinik Regensburg /ID# 201265 | Regensburg | Bavaria | 93053 | Germany |
| Universitatsklinikum Frankfurt /ID# 170300 | Frankfurt am Main | Hesse | 60590 | Germany |
| Univ Hosp Schleswig-Holstein, Campus Kiel, Klinik furer Innere Medizin /ID# 127199 | Kiel | Schleswig-Holstein | 24105 | Germany |
| Charite Universitatsmedizin Berlin Campus Virchow Klinikum /ID# 127203 | Berlin | 10117 | Germany |
| Mross, Berlin, DE /ID# 127201 | Berlin | 10318 | Germany |
| Gastrostudien GbR /ID# 169246 | Berlin | D-10825 | Germany |
| Asklepios Westklinikum Hamburg /ID# 127198 | Hamburg | 22559 | Germany |
| Universitaetsklinikum Jena /ID# 127205 | Jena | 07747 | Germany |
| EUGASTRO GmbH /ID# 127202 | Leipzig | 04103 | Germany |
| Universitatsklinikum Magdeburg /ID# 127200 | Magdeburg | 39120 | Germany |
| Gastro Campus Research GbR /ID# 126743 | Münster | 48159 | Germany |
| Pecsi Tudomanyegyetem Klinikai Kozpont I. sz. Belgyogyaszati Klinika /ID# 127209 | Pécs | Pecs | 7624 | Hungary |
| Magyar Elhizastudomanyi KKft. /ID# 126589 | Budapest | 1124 | Hungary |
| Pannonia Maganorvosi Centrum Kft. /ID# 127207 | Budapest | 1136 | Hungary |
| Szegedi Tudomanyegyetem /ID# 127208 | Szeged | 6720 | Hungary |
| Rabin Medical Center /ID# 127212 | Petakh Tikva | Tel Aviv | 4941492 | Israel |
| Tel Aviv Sourasky Medical Center /ID# 201365 | Tel Aviv | Tel Aviv | 6423906 | Israel |
| Soroka University Medical Center /ID# 127213 | Beersheba | 84101 | Israel |
| Hadassah University Hospital /ID# 127211 | Jerusalem | 91120 | Israel |
| Kaplan Medical Center /ID# 127210 | Rehovot | 76100 | Israel |
| A.O.U. Policlinico S.Orsola-Malpighi /ID# 129322 | Bologna | Emilia-Romagna | 40138 | Italy |
| Azienda Ospedaliera San Camillo Forlanini /ID# 127216 | Rome | Lazio | 00152 | Italy |
| Policlinico Agostino Gemelli /ID# 127217 | Rome | Lazio | 00168 | Italy |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 127138 | Milan | Lombardy | 20122 | Italy |
| IBD Center - IRCCS Istituto Clinico Humanitas /ID# 127215 | Rozzano | Milano | 20089 | Italy |
| Azienda Ospedaliera Spedali Civili /ID# 127236 | Brescia | 25123 | Italy |
| Universita di Padova /ID# 127214 | Padova | 35128 | Italy |
| Ospedali Riuniti Villa Sofia-C /ID# 129323 | Palermo | 90146 | Italy |
| Policlinico Univ Tor Vergata /ID# 129321 | Rome | 00133 | Italy |
| IRCCS Casa Sollievo /ID# 127811 | San Giovanni Rotondo | 71013 | Italy |
| Yokoyama IBD Clinic /ID# 151560 | Nagoya | Aichi-ken | 460-0022 | Japan |
| Nagoya City University Hospital /ID# 124517 | Nagoya | Aichi-ken | 467-8602 | Japan |
| Toho University Sakura Medical Center /ID# 124497 | Sakura-shi | Chiba | 285-8741 | Japan |
| Fukuoka University Chikushi Hospital /ID# 124155 | Chikushino-shi | Fukuoka | 818-8502 | Japan |
| Kyushu University Hospital /ID# 124495 | Fukuoka | Fukuoka | 812-8582 | Japan |
| Hidaka Clinic of Coloproctology /ID# 125477 | Kurume | Fukuoka | 839-0809 | Japan |
| Kurume University Hospital /ID# 125275 | Kurume-shi | Fukuoka | 830-0011 | Japan |
| Hiroshima University Hospital /ID# 124496 | Hiroshima | Hiroshima | 734-8551 | Japan |
| Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 124480 | Sapporo | Hokkaido | 060-0033 | Japan |
| Aoyama Clinic /ID# 127836 | Kobe | Hyōgo | 650-0015 | Japan |
| Hyogo College of Medicine College Hospital /Id# 127539 | Nishinomiya-shi | Hyōgo | 663-8501 | Japan |
| Kitasato University Hospital /ID# 137694 | Sagamihara-shi | Kanagawa | 252-0375 | Japan |
| COLO-PROCTOLOGY CENTER Matsushima Clinic /ID# 148423 | Yokohama | Kanagawa | 220-0045 | Japan |
| Susaki Kuroshio Hospital /ID# 125202 | Susaki-shi | Kochi | 785-8501 | Japan |
| Japanese Red Cross Kyoto Daiichi Hos /ID# 127540 | Kyoto | Kyoto | 605-0981 | Japan |
| Osaka Medical College Hospital /ID# 126451 | Takatsuki-shi | Osaka | 569-8686 | Japan |
| Saitama Medical Center /ID# 128875 | Kawagoe-shi | Saitama | 350-8550 | Japan |
| Shiga University of Medical Science Hospital /ID# 127675 | Ōtsu | Shiga | 520-2192 | Japan |
| Hamamatsu South Hospital /ID# 124481 | Hamamatsu | Shizuoka | 430-0846 | Japan |
| Medical Hospital of Tokyo Medical and Dental University /ID# 128315 | Bunkyo-ku | Tokyo | 113-8519 | Japan |
| Kitasato Univ Kitasato Inst Ho /ID# 127001 | Minato-ku | Tokyo | 108-8642 | Japan |
| Kyorin University Hospital /ID# 148184 | Mitaka-shi | Tokyo | 181-8611 | Japan |
| Wakayama Medical University /ID# 124635 | Wakayama | Wakayama | 641-8510 | Japan |
| Tokyo Yamate Medical Center /ID# 125201 | Tokyo | 169-0073 | Japan |
| Academisch Medisch Centrum /ID# 126741 | Amsterdam | North Holland | 1105 AZ | Netherlands |
| Szpital Uniwersytecki Nr 2 im. dr J.Biziela w Bydgoszczy /ID# 127141 | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-168 | Poland |
| Centrum Zdrowia MDM /ID# 170303 | Warsaw | Masovian Voivodeship | 00-635 | Poland |
| Endoterapia PFG Sp. z.o.o. /ID# 126513 | Warsaw | Masovian Voivodeship | 02-653 | Poland |
| Centrum Medyczne Pratia Gdynia /ID# 170301 | Gdynia | Pomeranian Voivodeship | 81-338 | Poland |
| NZOZ All-Medicus /ID# 128740 | Katowice | Silesian Voivodeship | 40-659 | Poland |
| H-T.Centrum Medyczne-Endoterapia /ID# 170305 | Tychy | Silesian Voivodeship | 43-100 | Poland |
| Centrum Medyczne LukaMed Joanna Luka /ID# 170302 | Chojnice | 89-600 | Poland |
| Centrum Medyczne Sw. Lukaza /ID# 126515 | Częstochowa | 42-200 | Poland |
| Centrum Diagnostyczno Lecznicze Barska /ID# 170304 | Lodz | 91-347 | Poland |
| KO-Med Centra Kliniczne Pulawy /ID# 127219 | Puławy | 24-100 | Poland |
| NZOZ Vivamed /ID# 127218 | Warsaw | 03-580 | Poland |
| C.M. Szpital Swietej Rodziny /ID# 127838 | Lodz | Łódź Voivodeship | 90-302 | Poland |
| Institutul Clinic Fundeni /ID# 127839 | Sector 2 | Bucharest | 022328 | Romania |
| CMDTA Neomed SRL /ID# 127142 | Brasov | 500283 | Romania |
| Spitalul Clinic Judetean de Urgenta /ID# 125418 | Cluj-Napoca | 400006 | Romania |
| Tvm Med Serv Srl /Id# 127221 | Cluj-Napoca | 400132 | Romania |
| Cabinet Medical Dr. Fratila SRL, Specialitatea Medicina Interna /ID# 127002 | Oradea | 410167 | Romania |
| Salvo-San-Ciobanca SRL /ID# 127140 | Zalău | 450117 | Romania |
| Gastroenterologicke centrum ASSIDUO a IBD centrum /ID# 127222 | Bratislava | 831 04 | Slovakia |
| Gastroenterologicka Ambulancia /ID# 125632 | Bratislava | 851 01 | Slovakia |
| Vseobecna Nemocnica s poliklinikou Lucenec /ID# 127322 | Lučenec | 984 01 | Slovakia |
| Hospital General Universitario de Alicante /ID# 129261 | Alicante | 03550 | Spain |
| Hospital Clinic de Barcelona /ID# 138147 | Barcelona | 08036 | Spain |
| Complejo Hospitalario Universitario de Ferrol /ID# 127840 | Ferrol | 15405 | Spain |
| Hospital Univ Dr. Negrin /ID# 127841 | Las Palmas de Gran Canaria | 35010 | Spain |
| Hospital Univ de la Princesa /ID# 135828 | Madrid | 28006 | Spain |
| Hospital General Universitario Gregorio Maranon /ID# 127224 | Madrid | 28007 | Spain |
| Hosp Univ 12 de Octubre /ID# 129257 | Madrid | 28041 | Spain |
| Hospital Universitario La Paz /ID# 127223 | Madrid | 28046 | Spain |
| Hosp Clin Univ de Valencia /ID# 170306 | Valencia | 46010 | Spain |
| Hosp Clin Univ Lozano Blesa /ID# 129255 | Zaragoza | 50009 | Spain |
| Kantonsspital St. Gallen /ID# 127843 | Sankt Gallen | Canton of St. Gallen | 9007 | Switzerland |
| University Hospital Zurich /ID# 127842 | Zurich | Canton of Zurich | 8006 | Switzerland |
| GI National Institute of Therapy named by L.T. Malaya /ID# 127231 | Kharkiv | Kharkiv Oblast | 61039 | Ukraine |
| Public Institution Kherson City Clinical Hospital named after le.le. Karabelesh /ID# 127233 | Kherson | 73000 | Ukraine |
| Municipal Clinical Hospital #8 /ID# 127235 | Kiev | 04201 | Ukraine |
| Lviv City Clinical Hospital NO.4 /ID# 127232 | Lviv | 79011 | Ukraine |
| CNPE City Hospital No.6 of Zaporizhzhia City Counsil /ID# 127137 | Zaporizhzhia | 69035 | Ukraine |
| Royal Hampshire County Hosp /ID# 169250 | Winchester | Hampshire | SO22 5DG | United Kingdom |
| Norfolk and Norwich Univ Hosp /ID# 127139 | Norwich | Norfolk | NR4 7UY | United Kingdom |
| Western General Hospital /ID# 204801 | Edinburgh | EH4 2XU | United Kingdom |
| St. Mark's Hospital /ID# 127226 | Harrow | HA1 3UJ | United Kingdom |
| Hull and East Yorkshire Hospitals NHS Trust /ID# 127225 | Hull | HU8 9HE | United Kingdom |
| Oxford University Hospitals NHS Foundation Trust The John Radcliffe Hospital /ID# 129324 | Oxford | OX3 9DU | United Kingdom |
| Southampton General Hospital /ID# 127228 | Southampton | SO16 6YD | United Kingdom |
| The Royal Wolverhampton NHS Tr /ID# 127227 | Wolverhampton | WV10 0QP | United Kingdom |
| Derived |
| Verstockt B, Pivorunas V, Al Mahi N, Smaoui N, Guay H, Kennedy NA, Goodhand JR, Lin S, Bai BYH, Hanauer SB, Ferrante M, Panes J, Vermeire S. Baseline TREM-1 Whole Blood Gene Expression Does Not Predict Response to Adalimumab Treatment in Patients with Ulcerative Colitis or Crohn's Disease in the SERENE Studies. J Crohns Colitis. 2024 Apr 23;18(4):493-505. doi: 10.1093/ecco-jcc/jjad170. |
| 36905528 | Derived | Ponce-Bobadilla AV, Stodtmann S, Chen MJ, Winzenborg I, Mensing S, Blaes J, Haslberger T, Laplanche L, Dreher I, Mostafa NM. Assessing the Impact of Immunogenicity and Improving Prediction of Trough Concentrations: Population Pharmacokinetic Modeling of Adalimumab in Patients with Crohn's Disease and Ulcerative Colitis. Clin Pharmacokinet. 2023 Apr;62(4):623-634. doi: 10.1007/s40262-023-01221-x. Epub 2023 Mar 11. |
| 34402466 | Derived | Greener T, Boland K, Milgrom R, Ben-Bassat O, Steinhart AH, Silverberg MS, Narula N. Higher adalimumab maintenance regimen is more effective than standard dose in anti-TNF experienced Crohn's disease patients. Eur J Gastroenterol Hepatol. 2021 Oct 1;33(10):1274-1279. doi: 10.1097/MEG.0000000000002250. |
Induction Higher Dose (I-HD): Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6. |
| FG002 | Maintenance (Main Study + Japan Sub-study): M-SD | Maintenance Standard Dose (M-SD): Double-blind adalimumab 40 mg every other week (eow), for 44 weeks. |
| FG003 | Maintenance (Main Study + Japan Sub-study): M-HD | Maintenance Higher Dose (M-HD): Double-blind adalimumab 40 mg every week (ew) for 44 weeks. |
| FG004 | Maintenance (Main Study): TDM Regimen | Exploratory Therapeutic Drug Monitoring (TDM) Regimen: Double-blind adalimumab 40 mg eow at Week 8 and Week 10, with possible dose adjustments at Weeks 12, 24, and 37 based on criteria assessing blinded adalimumab serum concentration and rectal bleeding subscore assessments. |
| Enrolled in Main Study |
|
| Enrolled in Japan Sub-Study |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Maintenance Study |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Induction (Main Study + Japan Sub-study): I-SD | Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6. |
| BG001 | Induction (Main Study + Japan Sub-study): I-HD | Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region | Count of Participants | Participants |
| ||||||||||||||||
| Full Mayo Score (FMS) | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). | participants with an assessment | Mean | Standard Deviation | units on a scale |
| |||||||||||||
| FMS: Rectal Bleeding Subscore | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). | participants with an assessment | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Induction Period Primary Endpoint: Percentage of Participants With Clinical Remission Per Full Mayo Score (FMS) at Week 8 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore > 1. | Induction Study Intent-to-Treat (ITT) set: all participants who were randomized at Baseline. Non-responder imputation. | Posted | Number | percentage of participants | Week 8 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Maintenance Period Primary Endpoint: Percentage of Week 8 Responders (Per FMS) With Clinical Remission (Per FMS) at Week 52 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders (per FMS) are defined as participants with a decrease in Full Mayo score of ≥ 3 points and ≥ 30% from Baseline plus a decrease from baseline in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore > 1. | ITT-Responder population (I-ITT-RP): all participants in the Induction ITT population who achieve Week 8 response based on the FMS utilizing the endoscopy subscore provided by the central reader. Non-responder imputation. Per protocol, the TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included). | Posted | Number | percentage of participants | Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Induction Period Ranked Secondary Endpoint 1: Percentage of Participants With Endoscopic Improvement at Week 8 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Endoscopic improvement is defined as an endoscopy subscore of 0 or 1. | Induction Study Intent-to-Treat (ITT) set: all participants who were randomized at Baseline. Non-responder imputation. | Posted | Number | percentage of participants | Week 8 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Induction Period Ranked Secondary Endpoint 2: Percentage of Participants With Fecal Calprotectin < 150 mg/kg at Week 8 | Induction Study Intent-to-Treat (ITT) set: all participants who were randomized at Baseline. Non-responder imputation. | Posted | Number | percentage of participants | Week 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Induction Period Ranked Secondary Endpoint 3: Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Response (Increase of IBDQ ≥ 16 From Baseline) at Week 8 | The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Total IBDQ score is the sum of the responses to the individual IBDQ questions, and ranges from 32 to 224 with higher scores indicating a better quality of life. | Induction Study Intent-to-Treat (ITT) set: all participants who were randomized at Baseline. Non-responder imputation. | Posted | Number | percentage of participants | Week 8 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Induction Period Ranked Secondary Endpoint 4: Percentage of Participants With Clinical Response Per FMS at Week 8 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical response is defined as a decrease in FMS of ≥ 3 points and ≥ 30% from baseline, plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. | Induction Study Intent-to-Treat (ITT) set: all participants who were randomized at Baseline. Non-responder imputation. | Posted | Number | percentage of participants | Week 8 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Induction Period Ranked Secondary Endpoint 5: Percentage of Participants With Endoscopic Remission at Week 8 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Endoscopic remission is defined as an endoscopy subscore of 0. | Induction Study Intent-to-Treat (ITT) set: all participants who were randomized at Baseline. Non-responder imputation. | Posted | Number | percentage of participants | Week 8 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Induction Period Ranked Secondary Endpoint 6: Percentage of Participants Achieving Response in IBDQ Bowel Symptom Domain at Week 8 | The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). The range for Bowel Symptom domain score is 10 (severe problem) to 70 (normal health). Response in IBDQ Bowel Symptom domain is defined as an increase of IBDQ Bowel Symptom domain score ≥ 6. | Induction Study Intent-to-Treat (ITT) set: all participants who were randomized at Baseline. Non-responder imputation. | Posted | Number | percentage of participants | Week 8 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Induction Period Ranked Secondary Endpoint 7: Percentage of Participants Achieving Response in IBDQ Fatigue Item at Week 8 | The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). The IBDQ Fatigue item score range is from 1 (severe problem) to 7 (normal health). Response is defined as an increase of IBDQ Fatigue item score ≥ 1. | Induction Study Intent-to-Treat (ITT) set: all participants who were randomized at Baseline. Non-responder imputation. | Posted | Number | percentage of participants | Week 8 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maintenance Period Ranked Secondary Endpoint 1: Percentage of Week 8 Responders (Per FMS) With Endoscopic Improvement at Week 52 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. Endoscopic improvement is defined as an endoscopy subscore of 0 or 1. | ITT-Responder population (I-ITT-RP): all participants in the Induction ITT population who achieve Week 8 response based on the FMS utilizing the endoscopy subscore provided by the central reader. Non-responder imputation. Per protocol, the TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included). | Posted | Number | percentage of participants | Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maintenance Period Ranked Secondary Endpoint 2: Percentage of Week 8 Responders With Steroid Usage at Baseline and Steroid Free at Least 90 Days at Week 52 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders, per FMS, are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. | I-ITT-RP: participants in the Induction ITT population who achieve Week 8 response based on the FMS utilizing the endoscopy subscore provided by the central reader. Participants with steroid use at Baseline. Non-responder imputation. Per protocol, TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included). | Posted | Number | percentage of participants | Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maintenance Period Ranked Secondary Endpoint 3: Percentage of Week 8 Responders With Steroid Usage at Baseline and Steroid Free at Least 90 Days and With Clinical Remission at Week 52 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders, per FMS, are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. Clinical remission is defined as FMS ≤ 2 with no subscore > 1. | I-ITT-RP: participants in the Induction ITT population who achieve Week 8 response based on the FMS utilizing the endoscopy subscore provided by the central reader. Participants with steroid use at Baseline. Non-responder imputation. Per protocol, TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included). | Posted | Number | percentage of participants | Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maintenance Period Ranked Secondary Endpoint 4: Percentage of Week 8 Remitters (Per FMS) With Clinical Remission (Per FMS) at Week 52 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1. Endoscopy subscore provided by the central reader. | ITT-Remitter (ITT-RM) Population included all participants in the ITT population who achieved Week 8 remission based on the FMS utilizing the endoscopy subscore provided by the central reader. Non-responder imputation. Per protocol, TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included). | Posted | Number | percentage of participants | Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maintenance Period Ranked Secondary Endpoint 5: Percentage of Week 8 Remitters (Per FMS) With Endoscopic Improvement at Week 52 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1. Endoscopic improvement is defined as an endoscopy subscore of 0 or 1. Endoscopy subscore provided by the central reader. | ITT-Remitter (ITT-RM) Population included all participants in the ITT population who achieved Week 8 remission based on the FMS utilizing the endoscopy subscore provided by the central reader. Non-responder imputation. Per protocol, TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included). | Posted | Number | percentage of participants | Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maintenance Period Ranked Secondary Endpoint 6: Percentage of Week 8 Remitters (Per FMS) With Steroid Usage at Baseline and Steroid Free at Least 90 Days at Week 52 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1. | ITT-RM Population: participants in ITT population who achieved Week 8 remission based on the FMS utilizing the endoscopy subscore provided by the central reader. Participants with steroid use at Baseline. Non-responder imputation. Per protocol, TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included). | Posted | Number | percentage of participants | Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maintenance Period Ranked Secondary Endpoint 7: Percentage of Week 8 Remitters (Per FMS) With Steroid Usage at Baseline and Steroid Free at Least 90 Days and With Clinical Remission (Per FMS) at Week 52 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1. | ITT-RM Population: all participants in the ITT population who achieved Week 8 remission based on the FMS utilizing the endoscopy subscore provided by the central reader. Participants with steroid usage. Non-responder imputation. Per protocol, the TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included). | Posted | Number | percentage of participants | Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maintenance Period Ranked Secondary Endpoint 8: Percentage of Week 8 Responders (Per FMS) With IBDQ Response (Increase of IBDQ ≥ 16 From Baseline) at Week 52 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Total IBDQ score is the sum of responses to the individual IBDQ questions, and ranges from 32 to 224 with higher scores indicating a better quality of life. | ITT-Responder population (ITT-RP): all participants in the Induction ITT population who achieve Week 8 response based on the FMS utilizing the endoscopy subscore provided by the central reader. Non-responder imputation. Per protocol, the TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included). | Posted | Number | percentage of participants | Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maintenance Period Ranked Secondary Endpoint 9: Percentage of Week 8 Non-Responders With Clinical Remission (Per FMS) at Week 52 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 non-responders are defined as participants not meeting the criteria of response (defined as a decrease in FMS of ≥ 3 points and ≥ 30% from baseline, plus a decrease in the rectal bleeding subscore [RBS] ≥ 1 or an absolute RBS ≤ 1) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1. | ITT-Non-Responder (ITT-NRP) Population: all participants in ITT who did not achieve Week 8 response based on the Full Mayo Score utilizing the endoscopy subscore provided by the central reader. Non-responder imputation. Per protocol, TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included). | Posted | Number | percentage of participants | Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maintenance Period Ranked Secondary Endpoint 10: Percentage of Week 8 Non-Remitters With Clinical Remission (Per FMS) at Week 52 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 non-remitters are defined as participants not meeting the criteria of clinical remission at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1. | ITT-Non-Remitter (ITT-NRM) Population: all participants in ITT who did not achieve Week 8 remission based on the FMS utilizing the endoscopy subscore provided by the central reader. Non-responder imputation. Per protocol, TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included). | Posted | Number | percentage of participants | Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maintenance Period Ranked Secondary Endpoint 11: Percentage of Week 8 Responders (Per FMS) With Endoscopic Subscore of 0 at Week 52 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders (per Full Mayo score) are defined as participants with a decrease in Full Mayo score of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. Endoscopic remission is defined as an endoscopy subscore of 0. | ITT-RP: participants in the Induction ITT population who achieve Week 8 response based on the FMS utilizing the endoscopy subscore provided by the central reader. Participants who were remitters at Week 8. Non-responder imputation. Per protocol, TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included). | Posted | Number | percentage of participants | Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maintenance Period Ranked Secondary Endpoint 12: Percentage of Week 8 Remitters (Per FMS) With Endoscopic Subscore of 0 at Week 52 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1. Endoscopic remission is defined as an endoscopy subscore of 0. | ITT-Remitter (ITT-RM) Population: all participants in ITT who achieved Week 8 remission based on the Full Mayo Score utilizing the endoscopy subscore provided by the central reader. Non-responder imputation. Per protocol, TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included). | Posted | Number | percentage of participants | Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maintenance Period Ranked Secondary Endpoint 13: Percentage of Week 8 Responders (Per FMS) With Response in IBDQ Bowel Symptom Domain at Week 52 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore [RBS] ≥ 1 or an absolute RBS ≤ 1. The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Bowel Symptom domain score range is 10 (severe problem) to 70 (normal health). Response is defined as increase of Bowel Symptom domain score ≥ 6 from baseline. | ITT-Responder population (ITT-RP): all participants in the Induction ITT population who achieve Week 8 response based on the FMS utilizing the endoscopy subscore provided by the central reader. Non-responder imputation. Per protocol, TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included). | Posted | Number | percentage of participants | Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maintenance Period Ranked Secondary Endpoint 14: Percentage of Week 8 Responders (Per FMS) With Response in IBDQ Fatigue Item at Week 52 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Response in IBDQ fatigue item (range 1 [severe problem] to 7 [normal health]) is defined as increase of IBDQ fatigue item ≥ 1 from baseline. | ITT-Responder population (ITT-RP): all participants in the Induction ITT population who achieve Week 8 response based on the FMS utilizing the endoscopy subscore provided by the central reader. Non-responder imputation. Per protocol, TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included). | Posted | Number | percentage of participants | Week 52 |
|
See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation.
Treatment-emergent adverse events (TEAEs) are presented.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Induction (Main Study + Japan Sub-study): I-SD | Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6. TEAEs during induction period: events with an onset date on or after first dose date of study drug in induction period and up to 70 days after last dose date of the study drug in induction period and prior to first dose date of study drug in maintenance period. Mean duration of treatment was 57.5 days. | 2 | 379 | 19 | 379 | 74 | 379 |
| EG001 | Induction (Main Study + Japan Sub-study): I-HD | Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6. TEAEs during induction period: events with an onset date on or after first dose date of study drug in induction period and up to 70 days after last dose date of the study drug in induction period and prior to first dose date of study drug in maintenance period. Mean duration of treatment was 55.0 days. | 4 | 573 | 22 | 573 | 112 | 573 |
| EG002 | Maintenance (Main Study + Japan Sub-study): M-SD | Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks. TEAEs during maintenance period: events with an onset date on or after first dose date of study drug in maintenance period and up to 70 days after the last dose date of the study drug in maintenance period. Mean duration of treatment was 251.5 days. | 2 | 345 | 44 | 345 | 140 | 345 |
| EG003 | Maintenance (Main Study + Japan Sub-study): M-HD | Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks. TEAEs during maintenance period: events with an onset date on or after first dose date of study drug in maintenance period and up to 70 days after the last dose date of the study drug in maintenance period. Mean duration of treatment was 263.1 days. | 2 | 350 | 44 | 350 | 141 | 350 |
| EG004 | Maintenance (Main Study): TDM Regimen | Double-blind adalimumab 40 mg eow at Week 8 and Week 10, with possible dose adjustments at Weeks 12, 24, and 37 based on criteria assessing blinded adalimumab serum concentration and rectal bleeding subscore (RBS) assessments. TEAEs during maintenance period: events with an onset date on or after first dose date of study drug in maintenance period and up to 70 days after the last dose date of the study drug in maintenance period. Mean duration of treatment was 255.9 days. | 0 | 151 | 15 | 151 | 47 | 151 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| LYMPHADENOPATHY | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| THROMBOCYTOSIS | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CARDIAC ARREST | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| MYOCARDIAL ISCHAEMIA | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| EYELID PTOSIS | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| OPTIC ATROPHY | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ANOGENITAL DYSPLASIA | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| COLITIS ULCERATIVE | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DUODENAL ULCER PERFORATION | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| LARGE INTESTINAL STENOSIS | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| MALLORY-WEISS SYNDROME | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| GAIT DISTURBANCE | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| BILE DUCT STONE | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HEPATITIS | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PORTOSPLENOMESENTERIC VENOUS THROMBOSIS | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| CLOSTRIDIUM DIFFICILE INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| CYTOMEGALOVIRUS COLITIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| ERYSIPELAS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| EXTERNAL EAR CELLULITIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| GASTROINTESTINAL INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| OTITIS EXTERNA | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| PELVIC INFLAMMATORY DISEASE | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| PERINEAL ABSCESS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| PERITONSILLAR ABSCESS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| STERNITIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| TUBERCULOSIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| TUBERCULOSIS OF INTRATHORACIC LYMPH NODES | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| VARICELLA | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| VIRAL INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| MENISCUS INJURY | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| PATELLA FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| POST PROCEDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| RADIUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| RIB FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| UPPER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HYPOVOLAEMIA | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| BLADDER CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| FIBROMATOSIS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| MALIGNANT MELANOMA IN SITU | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| NON-SMALL CELL LUNG CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| OESOPHAGEAL ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA OF THE CERVIX | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| UTERINE LEIOMYOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| ALTERED STATE OF CONSCIOUSNESS | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HYPOAESTHESIA | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ISCHAEMIC STROKE | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| MONONEUROPATHY | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| BINGE DRINKING | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| BIPOLAR DISORDER | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| NEPHROTIC SYNDROME | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PROSTATOMEGALY | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
| |
| EMPHYSEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| NASAL POLYPS | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| NASAL SEPTUM DEVIATION | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| SINUS POLYP | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ERYTHEMA NODOSUM | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| EXCESSIVE SKIN | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| LINEAR IGA DISEASE | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| NIGHT SWEATS | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PEMPHIGOID | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| SUBCORNEAL PUSTULAR DERMATOSIS | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| WOUND DRAINAGE | Surgical and medical procedures | MedDRA 22.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| THROMBOPHLEBITIS | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COLITIS ULCERATIVE | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
AbbVie 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. AbbVie 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 AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| SAP_001.pdf |
| Prot | Yes | No | No | Study Protocol | Jun 16, 2016 | Nov 19, 2020 | Prot_002.pdf |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Lack of Efficacy |
|
| Requires Alternative/Prohibited Therapy |
|
| Subject Non-Compliance |
|
| Other, Not Specified |
|
| Unknown Reason |
|
|
|
| Black or African American |
|
|
| Asian |
|
|
| Native Hawaiian/Other Pacific Islander |
|
|
| Multiracial |
|
|
| Missing |
|
|
|
| Japanese |
|
|
| Other, Not Specified |
|
|
|
| Non-United States |
|
|
|
|
| Breslow-Day test | Breslow-Day test of homogeneity across strata. | 0.447 | Superiority |
| Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use. | Cochran-Mantel-Haenszel | 0.301 | Adjusted risk difference | 2.3 | 2-Sided | 95 | -2.0 | 6.6 | Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose). | Superiority |
| Breslow-Day test | Breslow-Day test of homogeneity across strata. | 0.502 | Superiority |
| OG002 | Maintenance (Main Study + Japan Sub-study): M-SD | Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks. |
| OG003 | Maintenance (Main Study + Japan Sub-study): M-HD | Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks. |
|
|
|
Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.
| OG003 | Induction (Main Study + Japan Sub-study): I-HD | Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6. |
|
|
|
|
|
|
| OG003 | Induction (Main Study + Japan Sub-study): I-HD | Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6. |
|
|
|
Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6. |
| OG003 | Induction (Main Study + Japan Sub-study): I-HD | Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6. |
|
|
|
Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.
| OG003 | Induction (Main Study + Japan Sub-study): I-HD | Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6. |
|
|
|
| OG003 | Induction (Main Study + Japan Sub-study): I-HD | Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6. |
|
|
|
| OG003 | Induction (Main Study + Japan Sub-study): I-HD | Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6. |
|
|
|
| OG002 | Maintenance (Main Study + Japan Sub-study): M-SD | Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks. |
| OG003 | Maintenance (Main Study + Japan Sub-study): M-HD | Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks. |
|
|
|
| OG002 | Maintenance (Main Study + Japan Sub-study): M-SD | Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks. |
| OG003 | Maintenance (Main Study + Japan Sub-study): M-HD | Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks. |
|
|
|
Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.
| OG002 | Maintenance (Main Study + Japan Sub-study): M-SD | Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks. |
| OG003 | Maintenance (Main Study + Japan Sub-study): M-HD | Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks. |
|
|
|
| OG002 | Maintenance (Main Study + Japan Sub-study): M-SD | Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks. |
| OG003 | Maintenance (Main Study + Japan Sub-study): M-HD | Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks. |
|
|
|
| OG002 | Maintenance (Main Study + Japan Sub-study): M-SD | Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks. |
| OG003 | Maintenance (Main Study + Japan Sub-study): M-HD | Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks. |
|
|
|
| OG002 | Maintenance (Main Study + Japan Sub-study): M-SD | Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks. |
| OG003 | Maintenance (Main Study + Japan Sub-study): M-HD | Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks. |
|
|
|
| OG002 | Maintenance (Main Study + Japan Sub-study): M-SD | Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks. |
| OG003 | Maintenance (Main Study + Japan Sub-study): M-HD | Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks. |
|
|
|
| OG001 | Maintenance (Main Study): M-HD | Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks. |
| OG002 | Maintenance (Main Study + Japan Sub-study): M-SD | Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks. |
| OG003 | Maintenance (Main Study + Japan Sub-study): M-HD | Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks. |
|
|
|
| OG002 | Maintenance (Main Study + Japan Sub-study): M-SD | Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks. |
| OG003 | Maintenance (Main Study + Japan Sub-study): M-HD | Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks. |
|
|
|
| OG002 |
| Maintenance (Main Study + Japan Sub-study): M-SD |
Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks. |
| OG003 | Maintenance (Main Study + Japan Sub-study): M-HD | Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks. |
|
|
|
| OG002 | Maintenance (Main Study + Japan Sub-study): M-SD | Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks. |
| OG003 | Maintenance (Main Study + Japan Sub-study): M-HD | Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks. |
|
|
|
| OG002 | Maintenance (Main Study + Japan Sub-study): M-SD | Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks. |
| OG003 | Maintenance (Main Study + Japan Sub-study): M-HD | Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks. |
|
|
|
| OG001 | Maintenance (Main Study): M-HD | Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks. |
| OG002 | Maintenance (Main Study + Japan Sub-study): M-SD | Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks. |
| OG003 | Maintenance (Main Study + Japan Sub-study): M-HD | Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks. |
|
|
|
| OG001 | Maintenance (Main Study): M-HD | Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks. |
| OG002 | Maintenance (Main Study + Japan Sub-study): M-SD | Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks. |
| OG003 | Maintenance (Main Study + Japan Sub-study): M-HD | Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks. |
|
|
|