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Sponsored by: |
Abbott |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00055523 |
Purpose of the study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease when compared to placebo (an inactive substance)
Condition | Intervention | Phase |
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Crohn's Disease |
Drug: Adalimumab (D2E7) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion:
Principal Investigator: | Stephen B Hanauer, MD | University of Chicago Department of Medicine |
Study ID Numbers: | M02-403 |
Study First Received: | March 4, 2003 |
Last Updated: | August 11, 2006 |
ClinicalTrials.gov Identifier: | NCT00055523 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Anti-Inflammatory Agents Crohn's Disease Ileitis Gastrointestinal Diseases Enteritis Inflammatory Bowel Diseases Intestinal Diseases Adalimumab |
Ileal Diseases Antibodies Digestive System Diseases Crohn Disease Antirheumatic Agents Gastroenteritis Immunoglobulins |
Anti-Inflammatory Agents Ileitis Gastrointestinal Diseases Enteritis Inflammatory Bowel Diseases Intestinal Diseases Adalimumab |
Ileal Diseases Pharmacologic Actions Digestive System Diseases Therapeutic Uses Crohn Disease Gastroenteritis Antirheumatic Agents |