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

Sponsor
Schneider Children's Medical Center, Israel
Study ID
NCT02256462
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Adalimumab — DRUG
    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.

Study Details

Objectives: To examine the effect of drug level-based personalized treatment of adalimumab in children with Crohn's disease. Design: A prospective, randomized, open label study. Setting: Pediatric gastroenterology centers. Participants: Children 6 year to 17 years who are diagnosed with CD and are planned to receive adalimumab treatment. Main outcome measures: Pediatric Crohn's Activity Index (PCDAI) at 48 and 72 weeks. Secondary outcome measures: Corticosteroids free remission rates and on adalimumab at 48 and 72 weeks. The effect of routine adalimumab drug monitoring-based treatment on trough levels and anti-adalimumab antibodies during therapy.

Key Dates

Start date
May 1, 2015
Status verified
Sep 2021
Primary completion
Jan 31, 2019
Completion
Jan 31, 2019

Study Design

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

Arms

  • Experimental: Interventional
    Adalimumab levels and antibodies will be obtained with every laboratory examination (every 2 months, except for the first 2 visits). Dose or interval adjustment will be performed as followed:when trough levels results taken prior to ADA injection are above 5 µg/ml no change in dosing is required. Detectable levels below 5 µg/ml will result in interval decrease to every week. If levels are still below 5 µg/ml dose will be increased to 40 mg (in patients receiving less than 40 mg). Undetectable levels below 0.3µg/ml will be followed by antibodies (ATAs) measurement. If ATAs are persistently above 8 µg/ml the patient will discontinue the study. If ATAs are below 8 µg/ml ADA intervals will be decreased to every week.
  • No Intervention: Clinical
    Adalimumab levels and antibodies will be requested based on physician judgment when there are signs of loss of response (LOR). Dose and interval adjustment will be performed according to clinical measures: Following physician decision trough levels and ATAs will be collected and further adjustment may be considered according to results. Interval adjustment will be performed as described for the interventional arm. LOR is defined as PCDAI equal or higher than 10 or CRP higher than 0.5 mg/dl (5mg/l) and/or Fecal calprotectin higher than 150 mcg/gr (If lower than 150 at randomization).

Primary Outcome Measure

Loss of response (LOR) during treatment. [ Time Frame: Week 72 ]

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