Trials / Completed
CompletedNCT00055536
Safety and Efficacy of Natalizumab in Combination With Remicade in the Treatment of Crohn's Disease
A Phase II, Multi-Center, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, and Efficacy of Intravenous Antegren (Natalizumab) in Crohn's Disease Subjects Concurrently Receiving Remicade (Infliximab) and Not in Remission
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (planned)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | natalizumab |
Timeline
- Start date
- 2002-04-01
- Primary completion
- 2003-07-01
- Completion
- 2003-07-01
- First posted
- 2003-03-06
- Last updated
- 2016-06-16
Locations
18 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00055536. Inclusion in this directory is not an endorsement.