Reduce Risk for Crohn's Disease Patients

PHASE4CompletedINTERVENTIONAL
Enrollment

192

Participants

Timeline

Start Date

February 28, 2017

Primary Completion Date

June 14, 2021

Study Completion Date

June 14, 2021

Conditions
Crohn's Disease
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.

Trial Locations (1)

75015

Hôpital Necker -Enfants Malades (Service de gastro-enterologie), Paris

All Listed Sponsors
collaborator

European Commission

OTHER

lead

PIBD-Net

OTHER

NCT02852694 - Reduce Risk for Crohn's Disease Patients | Biotech Hunter | Biotech Hunter