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Methotrexate has been shown to be effective in treating Crohn disease, but its use in ulcerative colitis has not been as successful. In a multicenter, 48-week trial, subcutaneous methotrexate (25 mg once/week) was given first as open-label therapy for induction of remission in 179 patients with moderately active ulcerative colitis and nonresponse to other therapies, including biologics. Fifty-one percent of patients achieved response at week 16, and 84 patients entered a randomized, placebo-controlled, 32-week maintenance period. The proportion of patients in steroid-free remission at the end of the study period was no greater in the group receiving methotrexate compared with the placebo group (27% and 30%, respectively).