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NCT02065622 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis
A Phase 3 study of Ulcerative Colitis (UC), sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 952
- Enrollment target
- 20
- Study locations
NCT02065622: Completed Phase 3 study of Ulcerative Colitis (UC), sponsored by AbbVie.
NCT02065622 is a Phase 3 study of Ulcerative Colitis (UC) that has completed, run by AbbVie. The registered enrollment target is 952 participants, above the 709-participant average among 17 other Ulcerative Colitis (UC) trials with a reported enrollment target (34% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02065622, a Phase 3 study of Ulcerative Colitis (UC), has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 952 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
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 subscor
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Adalimumab
Study Locations (20)
Florida
- Gastro Florida /ID# 170619 - Clearwater
- Research Associates of South Florida,LLC /ID# 170309 - Miami
- Gastroenterology Group Naples /ID# 127806 - Naples
- Shafran Gastroenterology Ctr /ID# 122320 - Winter Park
Illinois
- Northwestern University Feinberg School of Medicine /ID# 122183 - Chicago
- University of Chicago /ID# 122302 - Chicago
- Carle Foundation Hospital /ID# 135955 - Urbana
Georgia
- Atlanta Gastro Assoc /ID# 122336 - Atlanta
- Gastro Assoc of Central GA /ID# 122318 - Macon
Maryland
- University of Maryland Med Ctr /ID# 169734 - Baltimore
- MGG Group, Inc.Chevy Chase Clinical Research /ID# 122238 - Chevy Chase
Alabama
- Digestive Health Specialists of the Southeast /ID# 127844 - Dothan
California
- Ucsd /Id# 122313 - La Jolla
Colorado
- Rocky Mountain Clinical Resear /ID# 122180 - Wheat Ridge
Connecticut
- Medical Research Ctr CT /ID# 122179 - Hamden
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 952 participants |
| Start Date | 2014-03-27 |
| Est. Completion | 2019-11-11 |
| Phase | Phase 3 |
What the finished NCT02065622 record still lists
NCT02065622 is an interventional study that assigns participants to a tested intervention. The registered 952 participants enrollment target is mid-sized for trials with a published cap, above the 709-participant average among 17 other Ulcerative Colitis (UC) trials with a reported enrollment target (34% higher).
The record links to 1 condition, with Ulcerative Colitis (UC) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02065622 names 20 study sites across 13 states, led by Florida, Illinois, Georgia.
Frequently Asked Questions
What is clinical trial NCT02065622 about?
NCT02065622 is a clinical study titled "Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis". 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.
What is the current status of trial NCT02065622?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 952 participants. The study started on 2014-03-27. Estimated completion is 2019-11-11.
What conditions does trial NCT02065622 study?
This clinical trial studies the following conditions: Ulcerative Colitis (UC).
What interventions are being tested in trial NCT02065622?
The interventions under investigation include: Placebo (OTHER), Adalimumab (DRUG).
Who is sponsoring clinical trial NCT02065622?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02065622 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Ulcerative Colitis (UC)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02065622's enrollment target sits among peer trials
952 3rd of 17 higher than 15 of 17 other Ulcerative Colitis (UC) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis (UC) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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