Low Dose Oral Methotrexate in Pediatric Crohn's Disease Patients Initiating Anti-Tumor Necrosis Factor (Anti-TNF) Therapy — COMBINE

Pediatric Crohn's Disease Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Pragmatic Clinical Trial To Evaluate The Effectiveness Of Low Dose Oral Methotrexate In Patients With Pediatric Crohn's Disease Initiating Anti-TNF Therapy

Status Completed

Clinical Trial Summary

The purpose of this study is to determine whether adding low dose methotrexate to anti -TNF therapy is more effective than treatment with anti-TNF therapy alone in inducing and maintaining steroid-free remission for children with Crohn's Disease.

Clinical Trial Description

Overall study duration: 6 years Multi-center study: up to 42 centers Number of subjects: 425 Duration of treatment for each subject: up to 156 weeks (3 years) The primary endpoint is percent of patients who experienced treatment failure over time. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02772965
Study type	Interventional
Source	University of North Carolina, Chapel Hill
Contact
Status	Completed
Phase	Phase 3
Start date	October 2016
Completion date	April 7, 2022

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See also
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Terminated	`NCT02694042` - Mission is Remission®: How Can a Disease Self-management Website Change Care?	N/A