drugset / Trial / NCT00055536
Safety and Efficacy of Natalizumab in Combination With Remicade in the Treatment of Crohn's Disease
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2002-04
- Primary completion
- 2003-07
- Completion
- 2003-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | natalizumab | Monoclonal antibody | — | Intravenous |