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Sponsored by: |
Abbott |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00348283 |
The goal of this study is to test whether adalimumab can induce mucosal healing in subjects with moderate to severe ileocolonic Crohn's Disease.
Condition | Intervention | Phase |
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Crohn's Disease |
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 Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects With Crohn's Disease Involving the Colon |
Enrollment: | 135 |
Study Start Date: | August 2006 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Double Blind: Placebo Comparator
Blinded study through Week 52. Adalimumab compared to Placebo during blinded portion.
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Biological: adalimumab
Adalimumab 40 mg Every Other Week Dosing through blinded portion of study, which continues through Week 52. Subjects may be switched to open-label every other week or open-label every week dosing to treat disease flare or non-response.
Biological: placebo
Placebo Every Other Week Dosing through blinded portion of study, which continues through Week 52. Subjects may be switched to open-label every other week or open-label every week dosing to treat disease flare or non-response.
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Open Label
Note: No comparator is used in Open Label portion of study. Open Label begins post Week 52
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Biological: adalimumab
Open Label begins post Week 52, interventions will be dosed in two different manners: 40 mg every other week or 40 mg weekly. There is no Placebo intervention post Week 52.
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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 A Paperiello | Abbott |
Responsible Party: | Abbott ( Barry Bittle ) |
Study ID Numbers: | M05-769 |
Study First Received: | June 30, 2006 |
Last Updated: | October 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00348283 |
Health Authority: | United States: Food and Drug Administration |
Antibodies, Monoclonal Antibodies Digestive System Diseases Gastrointestinal Diseases Crohn Disease |
Inflammatory Bowel Diseases Adalimumab Gastroenteritis Intestinal Diseases Immunoglobulins |
Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Pharmacologic Actions |