Phase III Randomized Study of Anti-Tumor Necrosis Factor Chimeric Monoclonal Antibody (cA2) for Patients With Enterocutaneous Fistulae as a Complication of Crohn's Disease
|ClinicalTrials.gov Identifier: NCT00004941|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : March 25, 2015
I. Evaluate the efficacy of chimeric monoclonal antibody (cA2) compared with placebo in closure of enterocutaneous fistulae in patients with Crohn's disease.
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Drug: monoclonal antibody cA2||Phase 3|
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified according to investigational site and number of fistulae (single vs multiple).
Patients are randomized to one of three treatment arms: Arm I: Patients receive an infusion of chimeric monoclonal antibody (cA2) on weeks 0, 2, and 6. Arm II: Patients receive an infusion of cA2 on weeks 0 and 2, and an infusion of placebo on week 6. Arm III: Patients receive an infusion of placebo on day 1 of weeks 0, 2, and 6.
Patients are followed every month for 3 months, then every 6-12 months for up to 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||94 participants|
|Study Start Date :||July 1996|
|Estimated Study Completion Date :||July 1996|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004941
|Study Chair:||Richard Vensel McCloskey||Centocor, Inc.|