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

Phase 3 Completed 94 enrolled FDA Office of Orphan Products Development Centocor, Inc. · collab

RandomizedDouble-blindTreatment

Summary

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

Timeline

Start: 1996-07
Primary completion: —
Completion: 1996-07

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Infliximab	Monoclonal antibody	—	—

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

Summary

Timeline

Drugs

Indications