COMMIT (Combination Of Maintenance Methotrexate-Infliximab Trial)
NCT00132899 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 128
Last updated 2013-12-11
Summary
The primary objective is to compare the efficacy and safety of infliximab plus methotrexate to infliximab alone for the long-term control of signs and symptoms of Crohn's disease (CD) in patients with symptoms that are persistent enough to require corticosteroid therapy.
Conditions
Interventions
- DRUG
-
Methotrexate
Methotrexate and infliximab combination
- DRUG
-
Placebo and infliximab combination therapy.
Sponsors & Collaborators
-
Schering-Plough
collaborator INDUSTRY -
University of Western Ontario, Canada
lead OTHER
Principal Investigators
-
Brian G Feagan, MD, M.Sc · Robarts Clinical Trials, Robarts Research Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-12-31
- Primary Completion
- 2008-02-29
- Completion
- 2008-07-31
Countries
- Canada
Study Locations
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