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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00132899
Date of registration: 19/08/2005
Prospective Registration: Yes
Primary sponsor: University of Western Ontario, Canada
Public title: COMMIT (Combination Of Maintenance Methotrexate-Infliximab Trial)
Scientific title: A Phase III Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Multi-Centre Study to Evaluate the Safety and Efficacy of Infliximab in Combination With Methotrexate for the Long-term Treatment of Crohn's Disease (CD)
Date of first enrolment: December 2005
Target sample size: 128
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00132899
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
Canada
Contacts
Name:     Brian G Feagan, MD, M.Sc
Address: 
Telephone:
Email:
Affiliation:  Robarts Clinical Trials, Robarts Research Institute
Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Crohn's Disease
Intervention(s)
Drug: Methotrexate
Drug: Placebo
Primary Outcome(s)
Treatment success as defined by the proportion of subjects in clinical remission (i.e. complete discontinuation of prednisone therapy and a CDAI score of <150) at week 14, and maintenance of clinical remission between study weeks 14 and 50 [Time Frame: one year]
Secondary Outcome(s)
Effects of infliximab therapy in combination with methotrexate on health-related quality of life [Time Frame: one year]
Efficacy of infliximab therapy in combination with methotrexate on disease activity using the Crohn's Disease Activity Index (CDAI) and Investigator and Subject Global Ratings [Time Frame: one year]
Proportion of subjects who develop antibodies to infliximab [Time Frame: one year]
Secondary ID(s)
RP0401
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Schering-Plough
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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