COMMIT (Combination Of Maintenance Methotrexate-Infliximab Trial)

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.