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Sponsored by: |
Mayo Clinic |
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Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00421642 |
This is an open-label study of 20 patients designed to demonstrate the safety, tolerability and preliminary evidence of benefit of adalimumab in the treatment of subjects with Ulcerative Colitis, both in patients who have never received anit-TNF agents and in those who have lost response or developed intolerance to previous infliximab therapy.
Condition | Intervention | Phase |
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Ulcerative Colitis |
Drug: Adalimumab |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study |
Official Title: | An Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Ulcerative Colitis Patients |
Estimated Enrollment: | 20 |
Study Start Date: | October 2006 |
Study Completion Date: | April 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
United States, Arizona | |
Mayo Clinic | |
Scottsdale, Arizona, United States, 85259 | |
United States, Illinois | |
University of Chicago | |
Chicago, Illinois, United States, 60637 | |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 |
Principal Investigator: | William J. Sandborn, M.D. | Mayo Clinic |
Responsible Party: | Mayo Clinic ( William Sandborn ) |
Study ID Numbers: | 06-002167 |
Study First Received: | January 11, 2007 |
Last Updated: | June 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00421642 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Anti-Inflammatory Agents Gastrointestinal Diseases Ulcer Colonic Diseases Inflammatory Bowel Diseases Colitis, Ulcerative Intestinal Diseases Adalimumab |
Antibodies, Monoclonal Antibodies Digestive System Diseases Antirheumatic Agents Gastroenteritis Colitis Immunoglobulins |
Anti-Inflammatory Agents Gastrointestinal Diseases Ulcer Colonic Diseases Inflammatory Bowel Diseases Colitis, Ulcerative Intestinal Diseases Adalimumab |
Pharmacologic Actions Digestive System Diseases Pathologic Processes Therapeutic Uses Gastroenteritis Antirheumatic Agents Colitis |