drugset / Trial / NCT02937285

National Multicenter, Controlled, Single-blind Study With Two Parallel Groups Evaluating the Safety and Efficacy of Sequential Treatment With Mitoxantrone and Interferon Versus Interferon Alone in Patients With Strong Risk of Progression in the Initial Phase of Multiple Sclerosis

NCT02937285

Phase 3 Completed 35 enrolled Rennes University Hospital
RandomizedParallel-groupSingle-blindTreatment

Summary

The relative effectiveness of current treatments and their different mechanisms of action yield to consider more and more that the multiple sclerosis (MS) therapeutic approach must use multiple molecules, both combined and sequential. In this sense, one can assume that the combination of two molecules with different but complementary mechanisms of action, can delay progression of the disease. Mitoxantrone has a powerful action, immediate and total, whereas interferon a selective action, immunomodulatory and delayed.

Timeline

Start
2010-12-06
Primary completion
2020-05-28
Completion
2020-05-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Interferon beta-1a Protein / enzyme biologic 44 ug Subcutaneous
Subject Mitoxantrone Small molecule 10 mg/m2

Indications