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

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ClinicalTrials.gov Identifier: NCT00207766
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : April 27, 2010
Information provided by:
Centocor, Inc.

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

Condition or disease Intervention/treatment Phase
Crohn Disease Drug: infliximab or placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: ACCENT II - A Randomized, Double-blind, Placebo-controlled Trial of Anti-TNF Chimeric Monoclonal Antibody (Infliximab, Remicade) in the Long Term Treatment of Patients With Fistulizing CROHN'S Disease
Study Start Date : June 2000
Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Infliximab
U.S. FDA Resources

Primary Outcome Measures :
  1. Reduction in the number of draining fistulas

Secondary Outcome Measures :
  1. Complete fistula response (no draining fistula).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00207766

Sponsors and Collaborators
Centocor, Inc.
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.

ClinicalTrials.gov Identifier: NCT00207766     History of Changes
Other Study ID Numbers: CR005413
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: April 27, 2010
Last Verified: January 2009

Keywords provided by Centocor, Inc.:
Crohn's Disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents