Salvage Therapy With High/Low Methotrexate for Loss of Response to Infliximab Dose Escalation

• Status: Completed
• Trial end date: 2018-10-09
• Target enrollment: 0
• Participant gender: All

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 methotrexate can maintain remission achieved by regular dose methotrexate by 6 months.

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

Details

• Lead Sponsor: Prof. Arie Levine
• Treatments: Infliximab; Methotrexate

Criteria

Inclusion Criteria:

1. Informed consent

2. Established diagnosis of Crohns disease.

3. Age: 8 - 18 years ( inclusive)

4. Active disease PCDAI >10 at least two weeks after infusion.

5. 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 Criteria:

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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