Back to resultsA Study of the Safety and Efficacy of Infliximab (Remicade) in Subjects With Fistulizing Crohn's Disease
Primary Purpose
Crohn Disease
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
infliximab or placebo
Sponsored by
About this trial
This is an interventional treatment trial for Crohn Disease focused on measuring Crohn's Disease, infusions
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Reduction in the number of draining fistulas
Secondary Outcome Measures
Complete fistula response (no draining fistula).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00207766
Brief Title
A Study of the Safety and Efficacy of Infliximab (Remicade) in Subjects With Fistulizing Crohn's Disease
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 Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
June 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Centocor, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
Keywords
Crohn's Disease, infusions
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
306 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
infliximab or placebo
Primary Outcome Measure Information:
Title
Reduction in the number of draining fistulas
Secondary Outcome Measure Information:
Title
Complete fistula response (no draining fistula).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Centocor, Inc. Clinical Trial
Organizational Affiliation
Centocor, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
15476155
Citation
Sands BE, Blank MA, Patel K, van Deventer SJ; ACCENT II Study. Long-term treatment of rectovaginal fistulas in Crohn's disease: response to infliximab in the ACCENT II Study. Clin Gastroenterol Hepatol. 2004 Oct;2(10):912-20. doi: 10.1016/s1542-3565(04)00414-8.
Results Reference
result
PubMed Identifier
14985485
Citation
Sands BE, Anderson FH, Bernstein CN, Chey WY, Feagan BG, Fedorak RN, Kamm MA, Korzenik JR, Lashner BA, Onken JE, Rachmilewitz D, Rutgeerts P, Wild G, Wolf DC, Marsters PA, Travers SB, Blank MA, van Deventer SJ. Infliximab maintenance therapy for fistulizing Crohn's disease. N Engl J Med. 2004 Feb 26;350(9):876-85. doi: 10.1056/NEJMoa030815.
Results Reference
result
Learn more about this trial
A Study of the Safety and Efficacy of Infliximab (Remicade) in Subjects With Fistulizing Crohn's Disease
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