A Randomized Double-Blind Placebo-Controlled Multi-Center Pragmatic Clinical Trial to Evaluate Effectiveness of Low Dose Oral Methotrexate in Patients with Pediatric Crohn's Disease Initiating Anti-TNF Therapy (COMBINE Umbrella)

S
Steven Steiner, MD

Primary Investigator

Overview

The purpose of this study is to determine whether, in children with Crohn?s disease (CD) initiating anti-TNF (anti-Tumor Necrosis Factor) biological therapy with infliximab or adalimumab, low-dose oral methotrexate (MTX) is more effective than placebo in the induction and subsequent maintenance of steroid-free remission for a treatment period of up to two years. We hypothesize that the addition of MTX to anti-TNF therapy will be more effective than placebo (i.e. anti-TNF monotherapy); and to determine whether, in children with CD initiating anti-TNF biological therapy with infliximab or adalimumab, low-dose oral MTX leads to better Patient Reported Outcomes (PROs) as compared to placebo. We hypothesize that the addition of MTX to anti-TNF therapy will result in better PROs than placebo (i.e. anti-TNF monotherapy).

Description

The purpose of this study is to determine whether, in children with Crohn?s disease (CD) initiating anti-TNF (anti-Tumor Necrosis Factor) biological therapy with infliximab or adalimumab, low-dose oral methotrexate (MTX) is more effective than placebo in the induction and subsequent maintenance of steroid-free remission for a treatment period of up to two years. We hypothesize that the addition of MTX to anti-TNF therapy will be more effective than placebo (i.e. anti-TNF monotherapy); and to determine whether, in children with CD initiating anti-TNF biological therapy with infliximab or adalimumab, low-dose oral MTX leads to better Patient Reported Outcomes (PROs) as compared to placebo. We hypothesize that the addition of MTX to anti-TNF therapy will result in better PROs than placebo (i.e. anti-TNF monotherapy).

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Crohn's disease
  • Age: - 20 Years
  • Gender: All

Inclusion Criteria
Crohn?s disease & Initiation of anti-TNF


Additional Information:
Participants will be compensated for their participation.

Updated on 20 Nov 2022. Study ID: 1607525710

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