Digestive System Diseases

All Conditions

Symptoms and General Pathology

Crohn Disease

Necrosis

Rare Diseases

Gastrointestinal Diseases

Fistula

Intestinal Diseases

Inflammatory Bowel Diseases

Gastroenteritis

All Drugs and Chemicals

Anti-Inflammatory Agents

Antirheumatic Agents

Dermatologic Agents

Gastrointestinal Agents

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Infliximab

Immunologic Factors

Tumor Necrosis Factor Inhibitors

monoclonal antibody cA2

Richard Vensel McCloskey

OBJECTIVES:

I. Evaluate the efficacy of chimeric monoclonal antibody (cA2) compared with placebo in closure of enterocutaneous fistulae in patients with Crohn's disease.

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.

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

Centocor, Inc.

FDA Office of Orphan Products Development

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	NCT00004941	Crohn's Disease	monoclonal anti...	18 Years - 65 Years	FDA Office of Orphan Products Development
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	NCT00004941	Crohn's Disease	monoclonal anti...	18 Years - 65 Years	FDA Office of Orphan Products Development

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