A Study of the Safety and Efficacy of Infliximab (Remicade) in Subjects With Fistulizing Crohn's Disease

Centocor Ortho Biotech

Status and phase: Completed; Phase 3

Conditions: Crohn Disease

Treatments: Drug: infliximab or placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00207766

CR005413

Details and patient eligibility

About

A study of infliximab in patients with Fistulizing Crohn's Disease

Full description

This is a medical research study for patients with Crohn's disease who have one or more draining enterocutaneous fistula (fistula from the bowel to the skin). Fistulas are a common complication of Crohn's disease. Fistulas rarely close spontaneously but they may get better with treatment of the underlying Crohn's disease. This study will investigate the safety and efficacy of maintenance dosing of an anti-TNF (anti-tumor necrosis factor) antibody (a protein), called infliximab, compared to a placebo (inactive substance) in providing sustained reductions in the number of draining fistulas.

Subjects will receive infliximab at weeks 0, 2 and 6 followed by infusions of infliximab 5 mg/kg or placebo at weeks 14 and every 8 weeks until week 46. Patients who lose response are eligible for increasing treatment by 5 mg/kg of infliximab.

Enrollment: 306 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Single or multiple draining fistulas
• Crohn's disease of at least 3 months' duration,

Exclusion criteria

• Crohn's disease complications for which surgery might be indicated
• Positive stool culture

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind