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
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|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004941
|Study Chair:||Richard Vensel McCloskey||Centocor, Inc.|