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NCT00055497 · ClinicalTrials.gov registry record · Phase 3
Remission in Subjects With Crohn's Disease, 1 Year Phase
A Phase 3 study of Crohn's Disease, sponsored by Abbott.
- Completed
- Registry status
- Phase 3
- Development phase
- 276
- Enrollment target
- 20
- Study locations
NCT00055497: Completed Phase 3 study of Crohn's Disease, sponsored by Abbott.
NCT00055497 is a Phase 3 study of Crohn's Disease that has completed, run by Abbott. The registered enrollment target is 276 participants, below the 2,392-participant average among 105 other Crohn's Disease trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00055497, a Phase 3 study of Crohn's Disease, has completed, sponsored by Abbott.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 276 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objectives were: (1) To demonstrate the efficacy of adalimumab in the maintenance of clinical remission up to 56 weeks in participants with Crohn's disease who participated in NCT00055523; (2) To delineate the safety of adalimumab when administered to participants with Crohn's disease up to 56 weeks.
Primary Outcome
Clinical remission is defined as CDAI score \<150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \>/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
Conditions Studied
Interventions
- BIOLOGICAL Double-blind (DB) adalimumab placebo
- BIOLOGICAL DB adalimumab 40 mg eow
- BIOLOGICAL DB adalimumab 40 mg ew
- BIOLOGICAL OL adalimumab 40 mg
Study Locations (20)
California
- Gastroenterology Associates of the East Bay - Berkeley
- Long Beach Gastroenterology Assoc. - Long Beach
- Sharp Rees-Stealy Medical Group - San Diego
Florida
- Cleveland Clinic Florida - Weston
- Wake Research Associates - Weston
- Shafran Gastroenterology Center - Winter Park
Massachusetts
- Massachusetts General Hospital - Boston
- Brigham and Women's Hospital - Boston
- Clinical Pharmacology Study Group - Worchester
Georgia
- Atlanta Gastroenterology Assoc. - Atlanta
- Southeastern Digestive & Liver Disease - Savannah
Illinois
- Northwest Gastroenterologists, S.C. - Arlington Heights
- University of Chicago - Chicago
Louisiana
- Drug Research Services, Inc. - Metairie
- LSU School of Medicine - New Orleans
Missouri
- Gastroenterology and Hepatology - Kansas City
- Glenn Gordon, MD - Mexico
Connecticut
- Gastroenterology Assoc. of Fairfield Co. - Bridgeport
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 276 participants |
| Start Date | 2002-08 |
| Est. Completion | 2008-12 |
| Phase | Phase 3 |
What the finished NCT00055497 record still lists
NCT00055497 is an interventional study that assigns participants to a tested intervention. The registered 276 participants enrollment target is mid-sized for trials with a published cap, below the 2,392-participant average among 105 other Crohn's Disease trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 4 interventions - of which Double-blind (DB) adalimumab placebo is the first listed.
NCT00055497 names 20 study sites across 10 states, led by California, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00055497 about?
NCT00055497 is a clinical study titled "Remission in Subjects With Crohn's Disease, 1 Year Phase". The objectives were: (1) To demonstrate the efficacy of adalimumab in the maintenance of clinical remission up to 56 weeks in participants with Crohn's disease who participated in NCT00055523; (2) To delineate the safety of adalimumab when administered to participants with Crohn's disease up to 56 w...
What is the current status of trial NCT00055497?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 276 participants. The study started on 2002-08. Estimated completion is 2008-12.
What conditions does trial NCT00055497 study?
This clinical trial studies the following conditions: Crohn's Disease.
What interventions are being tested in trial NCT00055497?
The interventions under investigation include: Double-blind (DB) adalimumab placebo (BIOLOGICAL), DB adalimumab 40 mg eow (BIOLOGICAL), DB adalimumab 40 mg ew (BIOLOGICAL), OL adalimumab 40 mg (BIOLOGICAL).
Who is sponsoring clinical trial NCT00055497?
This trial is sponsored by Abbott, which has 181 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00055497 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Crohn's Disease
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 NCT00055497's enrollment target sits among peer trials
276 43rd of 105 higher than 63 of 105 other Crohn's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn's Disease 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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