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Sponsored by: |
Abbott |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00338650 |
The primary objective of this study is to make adalimumab available to patients suffering from moderately to severely active Crohn's Disease who have failed to respond to, lost response to, or are intolerant to infliximab, and to evaluate safety
Condition | Intervention | Phase |
---|---|---|
Crohn's Disease |
Drug: adalimumab |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Open-Label Treatment Protocol of the Human Anti-TNF Monoclonal Antibody Adalimumab in Patients With Moderate to Severe Crohn's Disease With Previous Exposure to Infliximab |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Beverly Paperiello | Abbott |
Study ID Numbers: | M06-808, CHOICE |
Study First Received: | June 19, 2006 |
Last Updated: | November 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00338650 |
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 |