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ICN Research Explained: the COMBINE Trial
What was the key study finding?
The COMBINE study compared the treatment of pediatric Crohn’s disease with an anti-TNF biologic alone versus an anti-TNF biologic combined with low-dose oral methotrexate. The study found that adding methotrexate reduced the risk of treatment failure for adalimumab, but not for infliximab. Methotrexate did lead to more side effects, but these were mostly mild and rarely led to the stopping of treatment.
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
Researchers Announce Findings from Landmark Clinical Trial for Pediatric Crohn's Disease - UNC Health
ICN Posts
ImproveCareNow Researchers Announce Findings from Landmark Clinical Trial for Pediatric Crohn’s Disease
ImproveCareNow (ICN) is excited to share the findings from a years-long clinical trial COMBINE (Clinical Outcomes of Methotrexate Binary treatment with INfliximab or adalimumab in practice). The aim of this trial was to 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.
ImproveCareNow has been integral to this clinical trial from the beginning, including leading a research prioritization project in which the aim of this study was a top priority for members of the ICN community, to voting for the name of the study at the 2015 Community Conference. ICN care centers recruited for participation in this trial were vital to its success.
Below is an excerpt from an article highlighting the key takeaways of this important trial from Principal Investigator Mike Kappelman, MD, MPH’s care center, University of North Carolina at Chapel Hill.
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Hi, I'm Pam
I’m Pam, and I’m a member of the ICN Parent Working Group (PWG). My husband Kraig and I have three teenagers, and I became involved in ICN soon after our oldest son was diagnosed with Crohn’s disease. He first started having symptoms in the fall of 2015 and was diagnosed in March 2016.
COMBINE Now Enrolling Patient Participants
The COMBINE Study is now officially enrolling eligible patient participants. COMBINE is a research study looking to answer an important question: For kids with Crohn’s disease who need to start an anti-TNF medication (Remicade or Humira), does adding another medication called Methotrexate lead to better outcomes?
The COMBINE Study
“A journey of a thousand miles begins with a single step” – Chinese philosopher Laozi, 6th century BC
With great admiration, I have been witness to the strides that ImproveCareNow (ICN) has been making in our research efforts. As co-chair of the Research Committee, I am able to observe all of the wonderful ideas that the community puts forth for consideration. As with any learning curve, every step is not smooth, and we occasionally stumble and fall. Our colleagues are next to us ready to offer a helping hand though.
PCORI funding approved for pragmatic clinical trial to compare combination versus monotherapy in children with Crohn's disease
Michael D. Kappelman, MD, MPH of the University of North Carolina at Chapel Hill (read the UNC press release here) and the ImproveCareNow Network has been awarded $7.9 million in funding from the Patient Centered Outcomes Research Institute (PCORI) to conduct a five year study comparing Anti-TNF Monotherapy versus Combination Therapy with Low Dose Methotrexate in Pediatric Crohn’s Disease.