Skip to main content
Clinical Trials/NCT00055536
NCT00055536
Completed
Phase 2

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

Biogen18 sites in 1 country60 target enrollmentApril 2002

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Crohn's Disease
Sponsor
Biogen
Enrollment
60
Locations
18
Status
Completed
Last Updated
9 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
April 2002
End Date
July 2003
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Biogen
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Not specified

Study Sites (18)

Loading locations...

Similar Trials