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Sponsored by: |
Abbott |
Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00408629 |
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of the human anti-TNF monoclonal antibody adalimumab in subjects with moderately to severely active ulcerative colitis
Condition | Intervention | Phase |
Ulcerative Colitis |
Biological: adalimumab Biological: placebo |
Phase III |
Genetics Home Reference related topics: | Crohn disease |
MedlinePlus related topics: | Ulcerative Colitis |
Drug Information available for: | Adalimumab |
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 and Maintenance of Clinical Remission in Subjects With Moderately to Severely Active Ulcerative Colitis |
Estimated Enrollment: | 500 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
adalimumab group: Experimental |
Biological: adalimumab
Prefilled syringe, 40 mg, 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week between Weeks 4 and 52.
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placebo group: Experimental |
Biological: placebo
Matching Placebo for prefilled syringe, 40 mg,
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Active ulcerative colitis that is poorly controlled despite concurrent treatment with oral corticosteroids and/or immunosuppressants as defined below:
Exclusion Criteria:
Contact: Global Medical Information - Abbott | 1-800-633-9110 | medinfo@abbott.com |
Show 116 Study Locations |
Abbott |
Study Director: | Beverly Paperiello | Abbott |
Responsible Party: | Abbott ( Beverly Paperiello, Director, Immunology Clinical Program Management ) |
Study ID Numbers: | M06-827, EUDRACT: 2006-002782-40 |
First Received: | December 5, 2006 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00408629 |
Health Authority: | United States: Food and Drug Administration |
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