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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 27 June 2016
Main ID:  NCT00055536
Date of registration: 04/03/2003
Prospective Registration: No
Primary sponsor: Biogen
Public title: Safety and Efficacy of Natalizumab in Combination With Remicade in the Treatment of Crohn's Disease
Scientific title: 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
Date of first enrolment: April 2002
Target sample size: 60
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
United States
Key inclusion & exclusion criteria

- Male and female patients at least 18 years of age with at least a six-month history
of Crohn's disease and who are currently receiving Remicade and are not in remission
(CDAI greater than/equal to 150)

- Women must not be breastfeeding or pregnant, and must not become pregnant during the

Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Crohn's Disease
Drug: natalizumab
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Elan Pharmaceuticals
Ethics review
Results available:
Date Posted:
Date Completed:
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