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Sponsors and Collaborators: |
University of Pittsburgh Centocor, Inc. |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00688636 |
A randomized, placebo-controlled pilot study to determine endoscopic recurrence of Crohn's disease 12 months after curative, resective ileal or ileocolonic surgery in patients receiving post-operative infliximab or placebo
Condition | Intervention | Phase |
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Crohn's Disease |
Drug: infliximab Drug: placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Single Group Assignment |
Enrollment: | 24 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Drug: infliximab
5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
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2: Placebo Comparator |
Drug: placebo
placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
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Ages Eligible for Study: | 18 Years to 72 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
University of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15261 |
Principal Investigator: | Miguel D Regueiro, M.D. | University of Pittsburgh |
Responsible Party: | University of Pittsburgh ( Miguel Regueiro, M.D. ) |
Study ID Numbers: | C0168X75 |
Study First Received: | May 29, 2008 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00688636 |
Health Authority: | United States: Institutional Review Board |
Digestive System Diseases Infliximab Gastrointestinal Diseases Crohn Disease |
Inflammatory Bowel Diseases Gastroenteritis Intestinal Diseases Recurrence |
Anti-Inflammatory Agents Therapeutic Uses Gastrointestinal Agents |
Antirheumatic Agents Dermatologic Agents Pharmacologic Actions |