drugset / Trial / NCT01802593

Comparison of 2 Immunomodulator Withdrawal Schemes for Infliximab Monotherapy in Active Pediatric Crohn's Disease After Thiopurine Failure

NCT01802593 ↗

Phase 4 Terminated 20 enrolled Prof. Arie Levine
RandomizedParallel-groupOpen-labelTreatment

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 therapy, in prior Immunomodulator failures, is superior to monotherapy with Immunomodulator cessation from the second infusion, in preventing loss of remission to IFX.

Timeline

Start
2013-02
Primary completion
2015-12
Completion
2015-12

Outcome

Outcome not reported

Stopped: “lack of budget and failure to reach milestones”

Drugs

EvaluationDrugModalityDoseRoute
Subject 6-MP Unknown — —
Subject Azathioprine Small molecule — —
Subject Methotrexate Small molecule — —

Indications