A Study of the Safety and Efficacy of Infliximab (Remicade) in Subjects With Fistulizing Crohn's Disease
- Conditions
- Crohn Disease
- Registration Number
- NCT00207766
- Lead Sponsor
- Centocor, Inc.
- Brief Summary
A study of infliximab in patients with Fistulizing Crohn's Disease
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 306
- Single or multiple draining fistulas
- Crohn's disease of at least 3 months' duration,
- Crohn's disease complications for which surgery might be indicated
- Positive stool culture
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Reduction in the number of draining fistulas
- Secondary Outcome Measures
Name Time Method Complete fistula response (no draining fistula).