Conditions: Relapsing Forms of Multiple Sclerosis
Keywords: Relapsing Forms of Multiple Sclerosis Disease Modifying Therapy fingolimod Patient Reported Outcomes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1053
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the change in patient-reported outcomes, physician assessment of a change as well as safety and tolerability in patients with Relapsing Forms of Multiple Sclerosis on previous Disease Modifying Therapy (DMT) who are randomized to one of two treatment arms: fingolimod vs. standard of care DMT.

Detailed description:

Arms:
arm 1: Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period . arm 2: Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.

Interventions: intervention 1: Fingolimod intervention 2: Standard MS DMTs
Intervention descriptions: intervention 1: 0.5 mg/day oral capsule intervention 2: None

Protocol document: