NCT00269841 - An Efficacy and Safety Study of Anti-TNF Monoclonal Antibody in Patients With Fistulizing Crohn's Disease | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

May 31, 1996

Primary Completion Date

February 28, 1998

Study Completion Date

February 28, 1998

Conditions

Crohn Disease

Interventions

DRUG

Infliximab 10 mg/kg

Infliximab (anti-TNF chimeric monoclonal antibody \[cA2\]) 10 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2 and 6.

DRUG

Infliximab 5 mg/kg

Infliximab (anti-TNF chimeric monoclonal antibody \[cA2\]) 5 mg/kg will be administered as infusion at Week 0, 2 and 6.

DRUG

Placebo

Matching placebo will be adminstered at Week 0, 2 and 6.