Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: Relapsing Remitting Multiple Sclerosis (RRMS) Fingolimod Disease Modifying Therapy (DMT) TSQM-9
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 298
Healthy volunteers: no

Brief summary:
A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of (fingolimod) 0.5 mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease Modifying Therapy.

Detailed description:

Arms:
arm 1: Participants received 0.5 mg orally once a day. arm 2: Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.

Interventions: intervention 1: Fingolimod intervention 2: Interferon beta - 1a (IFN) intervention 3: Glatiramer acetate (GA)
Intervention descriptions: intervention 1: 0.5 mg orally once a day intervention 2: 44 mcg subcutaneously three times a week intervention 3: 20 mg subcutaneously once a day

Protocol document: