MERIT-UC: MEthotrexate Response In Treatment of Ulcerative Colitis
Randomized, double blind, prospective trial investigating the efficacy of Methotrexate in induction and maintenance of steroid free remission in ulcerative colitis
Kim Isaacs, James Lewis, Mark Osterman, Bruce Sands
We are facing a persistent unmet need for additional effective and affordable therapies for patients with ulcerative colitis (UC). Methotrexate (MTX) 25 mg once weekly administered subcutaneously (sq) or intramuscularly (im) is an efficient therapy to induce and maintain steroid free remission in patients with Crohn’s disease (CD). Several retrospective and prospective case series demonstrate similar clinical efficacy of MTX in patients with UC, when the drug was administered in a comparable dose and similar route (im or sq) as in CD 1, 2.
MERIT-UC is a prospective placebo controlled study to investigate the safety and efficacy of 25 mg MTX applied subcutaneously once weekly in patients with active UC, who are either steroid dependent or are intolerant or not responding to mesalamine or azathioprine/6-mercaptopurine therapy or have no response/ lost response to infliximab prior to the study inclusion. After an open label Induction Period in which each study participant applies MTX 25 mg sq once weekly over a 16 week time period with a concomitant steroid taper over 12 weeks, all participants of the study are randomized in the Maintenance Period to continue therapy with methotrexate or placebo weekly in a blinded fashion for 32 weeks.
MERIT-UC is conducted at sites of the Crohn’s and Colitis Foundation's Clinical Research Alliance and is funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).