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Reduce Risk for Crohn's Disease Patients — RCT  

Crohn's Disease Clinical Trial

Official title:
Risk-stratified Randomized Controlled Trial in Paediatric Crohn Disease:Methotrexate vs Azathioprine or Adalimumab for Maintaining Remission in Patients at Low or High Risk for Aggressive Disease Course, respectively-a Treatment Strategy

Clinical Trial Summary

The purpose of this study is to compare the effectiveness of weekly subcutaneously administered Methotrexate for maintaining relapse-free sustained steroid/Enteral Nutrition -free 1-year remission compared with:

- daily oral Azathioprine / 6 mercaptopurine in low risk paediatric Crohn's disease

- subcutaneously administered adalimumab in high risk paediatric Crohn's disease

Clinical Trial Description

In this randomized controlled trial PIBDNet (pediatric inflammatory bowel diseases network) aims to compare the following treatment strategy by dividing patients into two risk groups for aggressive disease evolution: the effectiveness of Methotrexate versus Azathioprine / 6 mercaptopurine for the maintenance of remission in Crohn's disease in children who are at low risk for aggressive disease and the effectiveness of Methotrexate versus adalimumab in the high risk group. PIBDNet hypothesizes that Methotrexate is superior to Azathioprine / 6 mercaptopurine for maintaining remission in Crohn's disease in the low risk strata and adalimumab is superior to Methotrexate in the high risk strata. In addition, the ancillary study is planned to analyse of Adalimumab treated patients from inclusion (TOP-Down) versus patients switched to Adalimumab due to failure of immunomodulator therapy (STEP-Up). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02852694
Study type Interventional
Source PIBD-Net
Contact Laetitia BIGOT, PhD
Phone +33144492572
Email lbigot@pibd-net.org
Status Recruiting
Phase Phase 4
Start date February 28, 2017
Completion date July 2022
View Details
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