Reduce Risk for Crohn's Disease Patients

Sponsor
PIBD-Net
Study ID
NCT02852694
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Methotrexate — DRUG
    Subcutaneous methotrexate once weekly 15mg/m2 body surface area (19, 30), with a maximal dose of 25mg/week. Odansetron (Zofran) premedication (4-8mg 1Hour prior to injection) is recommended, folate acid substitution (15mg po, 3 days after Methotrexate injection, for children \<20kg: 1x 5mg) is recommended.
  • Adalimumab — DRUG
    Subcutaneous Adalimumab started at a dose of 160mg followed by 80mg 2 weeks later and then 40mg every 2 weeks in patients over 40kg. In patients \< 40kg sc doses of Adalimumab are as follows: induction 160mg/1,73m2 BSA (max 160mg), followed by 80mg/1,73m2 Body surface area (max 80mg) 2 weeks later and maintenance of 40mg/1,73m2 Body surface area (max 40mg) every 2 weeks, all doses rounded up to the nearest 5 multiplications.
  • Azathioprine / 6 Mercaptopurine — DRUG
    Oral Azathioprine /6mercaptopurine at a dose of 2.5 mg/kg once daily rounded to the nearest multiplication of 12.5mg or oral 6mercaptopurine at a dose of 1.5mg/kg once daily rounded to the nearest multiplication of 12.5mg.

Study Details

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

Key Dates

Start date
Feb 28, 2017
Status verified
Jan 2025
Primary completion
Jun 14, 2021
Completion
Jun 14, 2021

Study Design

Enrollment
192 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: High Risk Group
    subcutaneous methotrexate versus subcutaneous adalimumab
  • Active Comparator: Low risk group
    subcutaneous methotrexate versus oral dose of azathioprine / 6 mercaptopurine
  • Other: Ancillary
    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).

Primary Outcome Measure

Rate of sustained steroid/EEN-free remission at Month 12 [ Time Frame: Month 12 ]

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