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)

Recruiting
20 years or below
All
Phase N/A
1 Location

Brief description of study

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).

Detailed description of study

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).

Participants will be compensated for their participation.

Eligibility of study

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

  • Conditions: Crohn's disease
  • Age: 20 years or below
  • Gender: All

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

Updated on 04 Aug 2024. Study ID: 1607525710

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