drugset / Trial / NCT01623596

Evaluation of Patient Retention of Fingolimod vs. Currently Approved Disease Modifying Therapy in Patients With Relapsing Remitting Multiple Sclerosis.

NCT01623596

Phase 4 Completed 881 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

A 12 month study where 852 patients with relapsing remitting MS will be randomized 1:1 to fingolimod or approved disease modifying therapy. Patients will be be treatment naive or have only been treated with one class of DMT (Interferon beta preparation or glatiramer acetate) . Patients will be able to switch to different treatment for safety, efficacy, tolerability or convenience during the study. Primary objective is to evaluate efficacy of fingolimod by assessing patients retention on treatment. Secondary objectives are to compare reasons for discontinuation, adverse events, cognitive impairment, medication satisfaction and change in brain volume measured by MRI.

Timeline

Start
2012-06-08
Primary completion
2015-07-13
Completion
2015-07-13

Drugs

EvaluationDrugModalityDoseRoute
Comparator Exctavia Unknown
Subject Fingolimod Small molecule
Comparator Glatiramer Acetate Small molecule
Comparator Interferon beta-1a Protein / enzyme biologic
Comparator Interferon beta-1b Protein / enzyme biologic