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Methotrexate vs Azathioprine or Adalimumab in Pediatric Crohn's Disease
NCT02852694Phase 4
Key facts
- Status
- Completed
- Start
- Feb 2017
- Primary completion
- Jun 2021
- Countries
- 1
- Sponsor
- PIBD-Net
- Modality
- Orthosteric Ligands
- Drugs
- methotrexate
- Conditions
- Crohn's disease
01
Overview
Phase 4, randomised, open-label trial of methotrexate in Crohn's disease (4 arms), sponsored by PIBD-Net. Primary endpoint: Rate of sustained steroid/EEN-free remission at Month 12. Started Feb 2017; status: completed.
02
Design
4 arms- Study design
- RandomizedOpen-label
High Risk: Methotrexate
Subcutaneous Methotrexate
High Risk: Adalimumab
Subcutaneous Adalimumab
Low Risk: Methotrexate
Subcutaneous Methotrexate
Low Risk: AZA/6MP
Oral Azathioprine or 6-Mercaptopurine
03
Who it enrols
Children 6-17 with new-onset Crohn's Disease requiring steroid or enteral nutrition induction. Patients are stratified into low or high risk based on disease severity and phenotype.
04
Endpoints
Primary
Rate of sustained steroid/EEN-free remission at Month 12
Secondary
Time to first relapse
Remission at 12 weeks
Linear height velocity
Steroid sparing effect of the regimens
Comparison of toxicity of the different protocol drugs
Questionnaire : health-related life of quality (IMPACT 3)
Questionnaire : TUMMY-CD
Questionnaire : WPAI:CD Caregiver
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