Pediatric Crohn's Disease AdalImumab Level-based Optimization Treatment (PAILOT) Trial

PHASE4CompletedINTERVENTIONAL
Enrollment

82

Participants

Timeline

Start Date

May 1, 2015

Primary Completion Date

January 31, 2019

Study Completion Date

January 31, 2019

Conditions
Crohn's Disease
Interventions
DRUG

Adalimumab

Eligible patients are those who are planned to start Adalimumab (ADA). Patients will be randomized at the first screening visits to either group 1 (interventional) or group 2 (clinical). Eligible patients, will start induction treatment (weeks 0,2) with ADA (\> 40kg 160/80/40 mg every 2 weeks or \< 40 kg 100/50/25 mg for m2 body surface area every 2 weeks). Interventions will start from the 4th injection for responding patients only (based on levels taken prior to the third injection). Responding patients will continue to the maintenance phase in which they will receive ADA every 2 weeks, either 40 mg or 25 mg/m2. At screening, and every 2 months all patients will be examined and have height, weight, PCDAI performed as well as comprehensive laboratory examinations.

Trial Locations (1)

4920235

Schneider Children's Hospital, Petah Tikva

All Listed Sponsors
lead

Schneider Children's Medical Center, Israel

OTHER

NCT02256462 - Pediatric Crohn's Disease AdalImumab Level-based Optimization Treatment (PAILOT) Trial | Biotech Hunter | Biotech Hunter