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Reduce Risk for Crohn's Disease Patients

NCT02852694 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2025-01-31

No results posted yet for this study

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

Conditions

Interventions

DRUG

Methotrexate

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.

DRUG

Adalimumab

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.

DRUG

Azathioprine / 6 Mercaptopurine

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.

Sponsors & Collaborators

Principal Investigators

  • Frank RUEMMELE, PhD / MD · PIBD-Net

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-28
Primary Completion
2021-06-14
Completion
2021-06-14

Countries

  • France

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02852694 on ClinicalTrials.gov