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)
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- STATUS
- Recruiting
Summary
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).
FAQ
Details
| Condition | Crohn's disease |
|---|---|
| Age | 20years or below |
| Clinical Study Identifier | TX7560 |
| Last Modified on | 19 February 2024 |
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