Anti-TNF Monotherapy versus Combination Therapy with Low Dose Methotrexate in Pediatric Crohn's Disease (The COMBINE Trial)


Study Dates

2016-10 - 2022-04

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PEDSnet

Abstract

Clinical trial to determine whether an intervention using an anti-TNF drug plus low-dose oral methotrexate is more effective than anti-TNF therapy alone among children with moderate-to-severe PCD who have not previously had anti-TNF therapy.

Affiliation(s)

University of North Carolina at Chapel Hill

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This research was made possible through the generous support of Patient-Centered Outcomes Research Institute. The statements presented in this work are solely the responsibility of the author(s) and do not necessarily represent the views of PCORI, its Board of Governors, or its Methodology Committee.

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Description

Crohn’s disease (CD), which affects about 600,000 Americans, causes abdominal pain and bloody diarrhea, leading to frequent hospitalizations, surgery, and decreased quality of life. Pediatric CD (PCD) affects about 38,000 children, is often progressive, and can impair both physical and emotional development. PCD treatment usually includes corticosteroids, anti-inflammatory aminosalicylates, immunosuppressives, or drugs that target tumor necrosis factor (TNF).

This large, pragmatic clinical trial determines whether an intervention using an anti-TNF drug plus low-dose oral methotrexate is more effective than anti-TNF therapy alone among children with moderate-to-severe PCD who have not previously had anti-TNF therapy. The primary measure of effectiveness will be achieving and maintaining a symptom-free remission, without the need for steroids, hospitalization, or surgery. In addition, we will identify and prioritize a set of patient-reported outcomes that will be used as another measure of effectiveness. Finally, we will compare the occurrence of moderate or severe treatment-related side effects.

Study Aims

  1. Determine whether methotrexate, in combination with anti-TNF therapy, is more effective than anti-TNF therapy alone in the induction and subsequent maintenance of remission for 2 years.
  2. Compare patient-reported outcomes.
  3. Describe investigator-reported adverse events.
  4. Collect blood serum from trial participants to facilitate future studies evaluating anti-TNF concentrations and antibody formation.

Read the PCORI Final Report here.

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a CC-BY 4.0 Attribution license.
Except where otherwised noted, this item's license is described as a CC-BY 4.0 Attribution license.

Cite this Study

Kappelman, M. Anti-TNF Monotherapy versus Combination Therapy with Low Dose Methotrexate in Pediatric Crohn's Disease (The COMBINE Trial). [Study]. PEDSpace Knowledge Bank. https://hdl.handle.net/20.500.14642/873

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