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Sponsored by: |
Millennium Pharmaceuticals, Inc. |
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Information provided by: | Millennium Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00619489 |
This is an open-label study to determine the long term safety of MLN0002 in patients with Crohn's disease and ulcerative colitis. Approximately 80 patients at centers in North America and Europe will participate in this study. The treatment and observation period is expected to last approximately 21 months.
Condition | Intervention | Phase |
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Ulcerative Colitis Crohn's Disease |
Drug: vedolizumab (MLN0002) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study |
Official Title: | Phase 2, Multiple Dose, Open-Label Study to Determine the Long Term Safety of MLN0002 in Patients With Ulcerative Colitis and Crohn's Disease |
Estimated Enrollment: | 80 |
Study Start Date: | December 2007 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Patients with no previous exposure to MLN0002 will receive the drug at a dose of 6 mg/kg
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Drug: vedolizumab (MLN0002)
Patients with no prior exposure to MLN0002 will receive 6 mg/kg of MLN0002 administered intravenously on Days 1, 15 and 43. After that patients will receive 6 mg/kg every 8 weeks for up to 78 weeks, followed by 90 day observation period for post-treatment assessments of safety.
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2: Experimental
Patients rolling over from a previous MLN0002 study will receive MLN0002 a dose of 2 mg/kg
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Drug: vedolizumab (MLN0002)
Patients rolling over from a previous MLN0002 study will follow the same dosing and follow-up schedule as Arm 1, however they will receive of a dose of 2 mg/kg.
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Confirmed and active UC or CD
Exclusion Criteria:
Responsible Party: | Millennium Pharmaceuticals ( Medical Monitor ) |
Study ID Numbers: | C13004 |
Study First Received: | February 11, 2008 |
Last Updated: | September 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00619489 |
Health Authority: | Canada: Health Canada; Russia: Pharmacological Committee, Ministry of Health |
Digestive System Diseases Gastrointestinal Diseases Ulcer Colonic Diseases Crohn Disease |
Inflammatory Bowel Diseases Colitis, Ulcerative Intestinal Diseases Gastroenteritis Colitis |
Pathologic Processes |