Status:
COMPLETED
Pediatric Crohn's Disease AdalImumab Level-based Optimization Treatment (PAILOT) Trial
Lead Sponsor:
Schneider Children's Medical Center, Israel
Conditions:
Crohn's Disease
Eligibility:
All Genders
6-17 years
Phase:
PHASE4
Brief Summary
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 gas...
Detailed Description
The efficacy of adalimumab in inducing and maintaining remission in both adults and children with moderate-to-severe Crohn's Disease has been demonstrated in multiple clinical trials. Despite efforts ...
Eligibility Criteria
Inclusion
- Crohn's disease
- Age 6-17 (inclusive)
- Naïve to biologics
- Informed consent
- Neg. TB-Test, negative HBV- S Ag
- Negative stool culture, parasites and clostridium toxin
- Inclusion criteria Comments:
- Patients receiving corticosteroids may be included if on taper-down scheduled to be completed by week 10.
- Partial enteral nutrition, accounting for less than 50% of daily required calories, may be supplied as needed.
- Patients receiving antibiotics must cease use of antibiotics within the 14 days of receiving the first injection. Excluding immunomodulators (azathioprine/6MP and methotrexate), any other targeted therapy for crohn's disease (i.e 5-ASA) must be stopped prior to ADA first injection. Immunomodulators will be required to be stopped either prior to first ADA injection or at 6 months following ADA initiation.
Exclusion
- Pregnancy.
- Renal Failure.
- Current abscess or perforation of the bowel.
- Small bowel obstruction within the last 6 months.
- Fixed non inflammatory stricture with related symptoms.
- Complicated or heavily draining perianal fistula (indolent non draining or minimally draining fistula are not an exclusion criteria).
- Prior treatment with infliximab or adalimumab.
- Previous malignancy.
- Sepsis or active bacterial infection.
- Surgery related to Crohn's disease in the previous 8 weeks.
- Positive Hepatitis B surface antigen or evidence for TB.
- IBD unclassified.
Key Trial Info
Start Date :
May 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2019
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT02256462
Start Date
May 1 2015
End Date
January 31 2019
Last Update
September 28 2021
Active Locations (1)
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1
Schneider Children's Hospital
Petah Tikva, Israel, 4920235