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

• Status: Completed
• Trial end date: 2019-01-31
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Schneider Children's Medical Center, Israel
• Treatments: Adalimumab

Criteria

Inclusion Criteria:

1. Crohn's disease

2. Age 6-17 (inclusive)

3. Naïve to biologics

4. Informed consent

5. Neg. TB-Test, negative HBV- S Ag

6. Negative stool culture, parasites and clostridium toxin

Inclusion criteria Comments:

1. Patients receiving corticosteroids may be included if on taper-down scheduled to be completed by week 10.

2. Partial enteral nutrition, accounting for less than 50% of daily required calories, may be supplied as needed.

3. 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 Criteria:

1. Pregnancy.

2. Renal Failure.

3. Current abscess or perforation of the bowel.

4. Small bowel obstruction within the last 6 months.

5. Fixed non inflammatory stricture with related symptoms.

6. Complicated or heavily draining perianal fistula (indolent non draining or minimally draining fistula are not an exclusion criteria).

7. Prior treatment with infliximab or adalimumab.

8. Previous malignancy.

9. Sepsis or active bacterial infection.

10. Surgery related to Crohn's disease in the previous 8 weeks.

11. Positive Hepatitis B surface antigen or evidence for TB.

12. IBD unclassified.