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Remission in Subjects With Crohn's Disease, 1 Year Phase
NCT00055497 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00055497
The ClinicalTrials.gov registry entry for NCT00055497 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 276 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott, which has 43 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00055497 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00055497?
This trial is sponsored by Abbott, which has 43 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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