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)
Investigating the Effectiveness of Low-Dose Methotrexate with Medications Blocking Inflammation in Children with Crohn's Disease
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).
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
This study investigates the effectiveness of adding low-dose oral methotrexate (MTX) to anti-TNF biological therapy in children with Crohn's disease. Anti-TNF therapy involves medications that block a protein called tumor necrosis factor, which can cause inflammation. The study aims to see if MTX helps maintain remission without the use of steroids over a period of two years.
Participants will be randomly assigned to receive either MTX or a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine. The study will monitor the effectiveness of MTX in improving patient-reported outcomes and maintaining remission.
- Who can participate: Children aged X to Y diagnosed with Crohn's disease who are starting anti-TNF therapy are eligible to participate.
- Study details: Participants will receive either low-dose oral methotrexate or a placebo alongside their anti-TNF therapy. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine.
- Study Timelines: The study will last two years.
Find a site
,
Send a message
Enter your contact details to connect with study team
