Clinical Outcomes of Methotrexate Binary treatment with infliximab or adalimumab in practice (COMBINE)

Purpose: The COMBINE Trial will study if treatment with a single anti-TNF medication (infliximab and adalimumab) or dual therapy that includes methotrexate is more effective in children with moderate to severe Crohn’s disease. COMBINE is the first study to look at this question in children with Crohn’s disease. We expect that 425 kids from across the US will enter the study. The results of this study can be used to help doctors choose medications that help children the most.

Funding Source (Year Awarded): Patient Centered Outcomes Research Institute (2015)

Study Period: 2015-2020

Recruitment Status: Complete - Manuscript published April 2023 in Gastroenterology

For more information

Clinical Research 101

Researchers Announce Findings from Landmark Clinical Trial for Pediatric Crohn's Disease - UNC Health

Comparative Effectiveness of Anti-TNF in Combination With Low-Dose Methotrexate vs Anti-TNF Monotherapy in Pediatric Crohn's Disease: A Pragmatic Randomized Trial on PubMed

ICN Posts

ICN Research Explained: The COMBINE trial 

ImproveCareNow Researchers Announce Findings From Landmark Clinical Trial for Pediatric Crohn's Disease 

PCORI funding approved for pragmatic clinical trial to compare combination versus monotherapy in children with Crohn's disease

The COMBINE Study