Status:
COMPLETED
COMMIT (Combination Of Maintenance Methotrexate-Infliximab Trial)
Lead Sponsor:
University of Western Ontario, Canada
Collaborating Sponsors:
Schering-Plough
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
The current approach to the treatment of Crohn's Disease is based on "step care". This strategy is relatively ineffective for the long-term management of patients who require treatment with corticoste...
Eligibility Criteria
Inclusion
- Male, or non-pregnant/non-lactating females, 18 or older
- Established Crohn's disease with active symptoms requiring prednisone therapy.
- Females of child-bearing potential must have a negative pregnancy test and must agree to use adequate contraception
Exclusion
- Intolerance or hypersensitivity to infliximab, methotrexate, prednisone and or known allergy to murine proteins or other chimeric proteins
- Are pregnant, nursing, or planning pregnancy (both men and women) during or in the 6 months after the study
- In the 2 months prior to screening, have had a serious infection, or have been hospitalized for and/or treated with intravenous (IV) antibiotics for infection. In the 6 months prior to screening, have had an opportunistic infection.
- After screening, need to continue non-study medical therapy for CD
- In the 8 weeks prior to screening, have received any of the following: systemic steroid therapy, azathioprine, 6-mercaptopurine, cyclosporine, probiotic products, or omega-3 fatty acids
- Have received any of the following: biologics in the last 6 months; methotrexate in the last year; and/or ever received infliximab.
- Have any of the following: biopsy-proven cirrhosis, clinically important lung disease, pre-existing demyelinating disorder, systemic lupus erythematosus, congestive heart failure, diabetes mellitus (insulin dependent), increased risk for steroid-related side effects, body weight 40% higher than standard, human immunodeficiency virus and/or hepatitis B or hepatitis C
- Have any of the following: an active draining fistula as the primary manifestation of CD; documented short bowel syndrome; a stoma; or severe, and/or fixed symptomatic stenosis of the intestine.
- Have had any of the following: clinically important bowel obstruction in the last 3 months; a bowel resection in the last 3 months; and/or other intra-abdominal surgery within 6 months.
- Clinically significant impairment in cardiac, liver or renal function; central nervous system (CNS), pulmonary, hematological, immunological, vascular and gastrointestinal disease in addition to CD; current malignancy or malignancy within 5 years prior to screening.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT00132899
Start Date
December 1 2005
End Date
July 1 2008
Last Update
December 11 2013
Active Locations (1)
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1
Robarts Clinical Trials, Robarts Research Institute
London, Ontario, Canada, N6A 5K8