Conditions: Multiple Sclerosis
Keywords: MS RMS Multiple Sclerosis Relapsing Multiple Sclerosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1346
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether ozanimod is effective in the treatment of relapsing multiple sclerosis (RMS).

Detailed description:

Arms:
arm 1: Participants received 30 µg interferon beta-1a by intramuscular (IM) injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally once a day until the last participant had been treated for 12 months. arm 2: Participants received ozanimod 0.5 mg capsules orally once a day and an intramuscular placebo injection (identical in appearance to Interferon) weekly until the last participant had been treated for 12 months. arm 3: Participants received ozanimod 1 mg capsules orally once a day and an intramuscular placebo injection (identical in appearance to Interferon) weekly until the last participant had been treated for 12 months.

Interventions: intervention 1: Ozanimod intervention 2: Interferon beta-1a intervention 3: Placebo to ozanimod intervention 4: Placebo to interferon beta-1a
Intervention descriptions: intervention 1: Capsules for oral administration once a day intervention 2: Administered by intramuscular injection once a week intervention 3: Matching placebo capsules administered orally once a day intervention 4: Placebo intramuscular injection once a week

Protocol document: