Status:
COMPLETED
Salvage Therapy With High/Low Methotrexate for Loss of Response to Infliximab Dose Escalation
Lead Sponsor:
Prof. Arie Levine
Conditions:
Crohn's Disease
Eligibility:
All Genders
8-18 years
Phase:
PHASE4
Brief Summary
The goal of the present study is to evaluate if addition of methotrexate can restore remission after loss of response to infliximab after dose escalation. another goal is to evaluate if low dose meth...
Detailed Description
Background: IFX mono-therapy became the method of choice for treatment in pediatric CD, though this strategy has been called into question due to frequent loss of response to IFX requiring dose escala...
Eligibility Criteria
Inclusion
- Informed consent
- Established diagnosis of Crohns disease.
- Age: 8 - 18 years ( inclusive)
- Active disease PCDAI \>10 at least two weeks after infusion.
- On Infliximab with at least 3 prior infusions, and still active despite a decreased dose interval ( ≤ 6 weeks) or increased dose of infliximab (≥7.5 mg/kg /dose q 8 weeks).
- Comment: Patients who are on combination therapy with a stable thiopurine\>8 weeks can also be included ( thiopurine will be stopped at enrollment).
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Exclusion
- 1\. Patients who are primary non responders after first two doses 2. Patients who have had to stop infliximab due to side effects. 3. Patients with known intolerance to methotrexate. 4. Elevated ALT \>1.5 normal. 5. Pregnancy. 6. Patients who have insulin-dependent diabetes 7. Patients who have significantly impaired renal function 8. Current bacterial infection/ inflammation including Hepatitis B or C and Pneumonia.
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Key Trial Info
Start Date :
July 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 9 2018
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT02269358
Start Date
July 1 2015
End Date
October 9 2018
Last Update
October 18 2018
Active Locations (1)
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1
The E. Wolfson.Medical Center
Holon, Israel, 58100