Status:
TERMINATED
Comparison of 2 Immunomodulator Withdrawal Schemes for Infliximab Monotherapy in Active Pediatric Crohn's Disease After Thiopurine Failure
Lead Sponsor:
Prof. Arie Levine
Conditions:
Crohn's Disease
Eligibility:
All Genders
6-18 years
Phase:
PHASE4
Brief Summary
The goal of the present study is to evaluate the best regimen for infliximab monotherapy, and to evaluate if limited combination therapy with IFX and an Immunomodulator for the first 6 months of thera...
Detailed Description
Background: Current data from studies and registries involving pediatric Crohn's disease indicate that 50-80% of children will receive an immunomodulator (IMM) as a maintenance therapy within 12 month...
Eligibility Criteria
Inclusion
- Crohns disease
- Age: 6 - 18 years ( inclusive)
- Active disease PCDAI \>10, or any steroid dependence despite thiopurine use for \>10 weeks.
- Naïve to biologics
- Informed consent
- CRP ≥0.6 mg/dl
- Neg. TB-Test, negative HBV- S Ag
- Use of IMM at present or in past for at least 10 weeks ( for Withdraw only).
- Negative stool culture, parasites and clostridium toxin current flare
- Inclusion criteria Comments:
- Patients receiving corticosteroids may be included if the disease is active and CRP elevated.
- All other treatments such as 5ASA , , must be discontinued immediately after the first IFX infusion.
- Patients may receive an antihistamine prior to any infusion.Use of corticosteroid pretreatment is allowed only during the first two infusions (single infusion on day of infliximab), or if an infusion reaction has occurred.
- 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 infusion.
- ESR \>20 can be alternative if the CRP \<0.6.
- Negative stool culture, parasites and clostridium toxin current flare will examined only if the patient has diarrhea.
- Patients may be enrolled directly in to the Predict study , in which case duration of IMM is irrelevant , but patients must have received an IMM until week 2 as in the withdraw
Exclusion
- Intolerance to thiopurines/methotrexate
- Pregnancy
- Contraindication for any of the drugs.
- Leukopenia \<4000 or absolute neutrophil count below 1200 on two consecutive tests during screening.
- Hepatocellular Liver disease ( ALT \> 60 ) or cirrhosis.
- Renal Failure
- Prior idiosyncratic side effects with thiopurines ( pancreatitis etc).
- Current abscess ( \< 14 days of antibiotics) or perforation of the bowel( \<14 days antibiotics).
- Small bowel obstruction within the last 3 months
- Fixed non inflammatory stricture with predilatation with symptoms related to stricture
- Complicated or heavily draining perianal fistula ( indolent non draining or scant draining fistula are not exclusion criteria)
- Prior treatment with infliximab
- Previous malignancy
- Toxic Megacolon
- Sepsis
- Surgery related to Crohn's disease in previous 8 weeks.
- Positive Hepatitis B surface antigen or evidence for TB.
- Current bacterial infection
- IBD unclassified
- Exclusion criteria Comments:
- 1\. Prior surgery or post operative recurrence are not exclusion criteria.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01802593
Start Date
February 1 2013
End Date
December 1 2015
Last Update
December 22 2015
Active Locations (1)
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1
The E. Wolfson.Medical Center
Holon, Israel, 58100