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

Drugs

EvaluationDrugModalityDoseRoute
Subject Azathioprine Small molecule
Subject MERCAPTOPURINE ANHYDROUS Small molecule
Subject Methotrexate Small molecule

Indications