drugset / Trial / NCT01802593
Comparison of 2 Immunomodulator Withdrawal Schemes for Infliximab Monotherapy in Active Pediatric Crohn's Disease After Thiopurine Failure
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azathioprine | Small molecule | — | — |
| Subject | MERCAPTOPURINE ANHYDROUS | Small molecule | — | — |
| Subject | Methotrexate | Small molecule | — | — |