Clinical Outcomes of Methotrexate Binary Therapy in Practice (COMBINE)

Project start date and end date: 2016 to 2021

Background:
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: https://combinetrial.org

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

Project Manager:
Ila Moncion

1500 E. Medical Center Drive
MPB D5200, Box SPC5718

Phone: 734-763-9650
Fax: 734-763-7359
Email: ilajm@med.umich.edu

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