NCT01393405.

Trial name or title	Randomized, double blind, prospective trial investigating the efficacy of methotrexate in induction and maintenance of steroid free remission in ulcerative colitis (MEthotrexate Response In Treatment of UC ‐ MERIT‐UC)
Methods	Double‐blind, placebo controlled, randomized, multicenter, parallel group trial
Participants	Active ulcerative colitis (n = 220)
Interventions	Methotrexate: induction period (week 1‐16) (open label): 25 mg MTX subcutaneous (sq) once weekly + steroid taper + 1 mg folic acid daily; maintenance period (week 17‐48) (randomization):25 mg MTX sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine Placebo: sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine
Outcomes	Primary outcome: relapse free survival Secondary outcome: mucosal healing and relapse of disease Aims of the study: i) the safety and tolerability MTX over 48 weeks; ii) the relapse‐free survival of MTX maintenance therapy compared to placebo over 32 weeks; iii) the efficacy of MTX to induce steroid free remission over 16 weeks; iv) the evaluation of clinical and pharmacogenomic models to predict the response to MTX therapy in patients with UC
Starting date	February 2012
Contact information	Hans Herfarth, Tel: 919‐966‐6806, Email: hherf@med.unc.edu
Notes	NCT01393405, estimated completion date is June 2016