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Sponsored by: |
Abbott |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00385736 |
The objective of this study is to assess the efficacy and safety of adalimumab for the induction of clinical remission in subjects with moderately to severely active ulcerative colitis.
Condition | Intervention | Phase |
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Ulcerative Colitis |
Biological: adalimumab Biological: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Blind Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderately to Severely Active Ulcerative Colitis |
Enrollment: | 576 |
Study Start Date: | November 2006 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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adalimumab 1: Experimental |
Biological: adalimumab
Prefilled syringe, 40 mg (loading dose then every other week dosing). 80 mg at Week 0, 40 mg at Week 2 and then 40 mg every other week, Open Label at Week 8
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adalimumab 2: Experimental |
Biological: adalimumab
Prefilled syringe, 40 mg (loading dose then every other week dosing). 160 mg at Week 0, 80 mg at Week 2 and then 40 mg every other week, Open Label at Week 8
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Placebo: Placebo Comparator |
Biological: placebo
Placebo for 40 mg syringe. Matching placebo for loading dose and every other week dosing, Open Label at Week 8
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Beverly Paperiello | Abbott |
Responsible Party: | Abbott ( Beverly Paperiello, Director, Immunology Clinical Program Management ) |
Study ID Numbers: | M06-826, EudraCT : 2006-002781-20 |
Study First Received: | October 9, 2006 |
Last Updated: | April 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00385736 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 |