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


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dc.contributorPatient-Centered Outcomes Research Institute
dc.contributor.authorKappelman, Michael
dc.contributor.otherUniversity of North Carolina at Chapel Hill
dc.date.accessioned2024-10-25T21:12:03Z
dc.descriptionCrohn'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](https://www.pcori.org/research-results/2015/comparing-safety-and-effectiveness-medicines-treat-crohns-disease-children-and-adolescents-combine-trial).
dc.description.abstractClinical 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.
dc.identifier.urihttps://hdl.handle.net/20.500.14642/873
dc.language.isoen
dc.publisherPEDSnet
dc.relation.isreferencedbyKappelman MD, Adler J, Ammoury RF, Bass DM., Bass JA, Benkov K, Boccieri ME, Bousvaros A, et al. 2023. "Comparing the Safety and Effectiveness of Medicines to Treat Crohn's Disease in Children and Adolescents - The COMBINE Trial. Final Research Report". PCS-1406-18643, Washington, DC: Patient-Centered Outcomes Research Institute.<br> DOI:[10.25302/11.2023.PCS.140618643](https://doi.org/10.25302/11.2023.PCS.140618643)
dc.rightsa CC-BY 4.0 Attribution license.
dc.rights.urihttps://creativecommons.org/licenses/by-sa/4.0/
dc.subjectClinical Trial
dc.subjectPEDSnet Data Source
dc.subjectPCORI-Funded Research
dc.subject.meshCrohn Disease
dc.subject.meshInflammatory Bowel Diseases
dc.subject.meshGastrointestinal Diseases
dc.subject.meshTumor Necrosis Factor Inhibitors
dc.subject.meshAnti-Inflammatory Agents
dc.subject.meshEnzyme Inhibitors
dc.subject.meshNucleic Acid Synthesis Inhibitors
dc.subject.meshDigestive System Diseases
dc.titleAnti-TNF Monotherapy versus Combination Therapy with Low Dose Methotrexate in Pediatric Crohn's Disease (The COMBINE Trial)
dspace.entity.typeStudy
local.admin.noteStudy PM: UNKNOWN, Study Analysts:
local.contributor.siteLeadPEDSnet Data Coordinating Center
local.contributor.siteSponsorPEDSnet Data Coordinating Center
local.contributor.sitesChildren's Hospital of Philadelphia
local.contributor.sitesCincinnati Children's Hospital Medical Center
local.description.analyticsStudy cohort comprised of participants, recruited through the Improve Care Now (ICN) Learning Health System, less than 18 years old, have moderate-to-severe PCD, and who are just beginning anti-TNF therapy. Participants are randomly assigned to receive either anti-TNF therapy and oral methotrexate (combination therapy) or anti-TNF monotherapy alone; they are followed for 2 years.
local.identifier.pedsnetid2016.KAPM.PCORI.DCC
project.endDate2022-04
project.startDate2016-10
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relation.isPublicationOfStudy.latestForDiscoveryff9e159c-576e-4555-8172-c89da7fb29a1

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