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Sponsored by: |
Abbott |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00105300 |
The goal of this study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease who have been initially treated with infliximab and either lost response or discontinued its use as a result of intolerance to the drug.
Condition | Intervention | Phase |
---|---|---|
Crohn's Disease |
Drug: Adalimumab |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderate to Severe Crohn's Disease Who Have Lost Response or Are Intolerant to Infliximab |
Estimated Enrollment: | 300 |
Study Start Date: | October 2004 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Global Medical Information 1-800-633-9110 | Abbott |
Study ID Numbers: | M04-691 |
Study First Received: | March 11, 2005 |
Last Updated: | August 13, 2006 |
ClinicalTrials.gov Identifier: | NCT00105300 |
Health Authority: | United States: Food and Drug Administration |
Antibodies, Monoclonal Antibodies Digestive System Diseases Infliximab Gastrointestinal Diseases Crohn Disease |
Inflammatory Bowel Diseases Adalimumab Gastroenteritis Intestinal Diseases Immunoglobulins |
Anti-Inflammatory Agents Immunologic Factors Therapeutic Uses |
Physiological Effects of Drugs Antirheumatic Agents Pharmacologic Actions |