Clinical Outcomes of Methotrexate Binary Therapy in Practice (COMBINE)

Project start date and end date: 2016 to 2021

Crohn’s disease (CD) commonly requires treatment with an anti-tumor necrosis factor (TNF) medication such as infliximab (Remicade) or adalimumab (Humira). There may be an added benefit of also treating with methotrexate at the same time as the anti-TNF medication. The COMBINE trial is a multicenter randomized trial of patients with CD who are starting anti-TNF medication. Participants will be randomized to receive either methotrexate or placebo in addition to the anti-TNF prescribed.

Trial website:

This project is funded by the Patient Centered Outcomes Research Institute (PCORI).

Related Publication:
Miller TL, Schuchard J, Carle AC, Forrest CB, Kappelman MD; COMBINE Study Group.
Use of Patient-Reported Outcomes Measurement Information System Pediatric Measures as Clinical Trial Endpoints: Experience from a Multicenter Pragmatic Trial in Children with Crohn's Disease.
J Pediatr. 2022;242:86-92.e3. doi:10.1016/j.jpeds.2021.10.053

For more information, please contact:
Clinical Professor, Department of Pediatrics, Division of Pediatric Gastroenterology
Interim Director, Susan B. Meister Child Health Evaluation and Research Center
1500 E. Medical Center Drive
MPB D5200, Box SPC5718
Ann Arbor, MI 48109-5718