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NCT00055536 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Natalizumab in Combination With Remicade in the Treatment of Crohn's Disease
A Phase 2 study of Crohn's Disease, sponsored by Biogen.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 18
- Study locations
NCT00055536: Completed Phase 2 study of Crohn's Disease, sponsored by Biogen.
NCT00055536 is a Phase 2 study of Crohn's Disease that has completed, run by Biogen. The registered enrollment target is 60 participants, below the 2,394-participant average among 105 other Crohn's Disease trials with a reported enrollment target (97% lower). The trial reports 18 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00055536, a Phase 2 study of Crohn's Disease, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 18
- Study locations
Study Summary
The purpose of this study is to determine the safety, tolerability, and efficacy of natalizumab in individuals diagnosed with active Crohn's Disease that are not in remission (CDAI greater than/equal to 150) and are currently taking Remicade. It is thought that natalizumab may stop the movement of certain cells, known as white blood cells, into bowel tissue. These cells are thought to cause damage in the bowel leading to the symptoms of Crohn's disease. Patients who complete this study may be eligible for long-term natalizumab therapy via extension protocol ELN100226-351.
Conditions Studied
Interventions
- DRUG natalizumab
Study Locations (18)
North Carolina
- Asheville Gastroenterology - Asheville
- Wake Research Associates - Raleigh
- Boice-Willis Clinic - Rocky Mount
Florida
- Digestive Disease Associates - Gainesville
- Borland Groover Clinic - Jacksonville
Tennessee
- Gastroenterology Center of the MidSouth - Memphis
- Memphis Gastroenterology Group - Memphis
Virginia
- Internal Medicine Associates - Danville
- Gastroenterology Consultants - Virginia Beach
Washington
- Virginia Mason Medical Center - Seattle
- Digestive Health Specialists - Tacoma
Georgia
- Atlanta Gastroenterology Associates - Atlanta
Kentucky
- University of Kentucky Medical Center - Lexington
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2002-04 |
| Est. Completion | 2003-07 |
| Phase | Phase 2 |
What the finished NCT00055536 record still lists
NCT00055536 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 2,394-participant average among 105 other Crohn's Disease trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 1 intervention - of which natalizumab is the first listed.
NCT00055536 lists 18 locations in 12 states (North Carolina, Florida, Tennessee).
Frequently Asked Questions
What is clinical trial NCT00055536 about?
NCT00055536 is a clinical study titled "Safety and Efficacy of Natalizumab in Combination With Remicade in the Treatment of Crohn's Disease". The purpose of this study is to determine the safety, tolerability, and efficacy of natalizumab in individuals diagnosed with active Crohn's Disease that are not in remission (CDAI greater than/equal to 150) and are currently taking Remicade. It is thought that natalizumab may stop the movement of c...
What is the current status of trial NCT00055536?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2002-04. Estimated completion is 2003-07.
What conditions does trial NCT00055536 study?
This clinical trial studies the following conditions: Crohn's Disease.
What interventions are being tested in trial NCT00055536?
The interventions under investigation include: natalizumab (DRUG).
Who is sponsoring clinical trial NCT00055536?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00055536 being conducted?
This trial has 18 study locations across Florida, Georgia, Kentucky, Massachusetts, Montana. 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 NCT00055536's enrollment target sits among peer trials
60 78th of 105 higher than 27 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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