A Phase 3, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of RPC1063 Administered Orally To Relapsing Multiple Sclerosis Patients
Overview
- Phase
- Phase 3
- Intervention
- Interferon beta-1a
- Conditions
- Multiple Sclerosis
- Sponsor
- Celgene
- Enrollment
- 1346
- Locations
- 223
- Primary Endpoint
- Adjusted Annualized Relapse Rate (ARR) During the Treatment Period
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to determine whether ozanimod is effective in the treatment of relapsing multiple sclerosis (RMS).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Multiple sclerosis as diagnosed by the revised 2010 McDonald criteria
- •EDSS score between 0 and 5.0 at baseline
Exclusion Criteria
- •Primary progressive multiple sclerosis
Arms & Interventions
Interferon beta-1a
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.
Intervention: Interferon beta-1a
Interferon beta-1a
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.
Intervention: Placebo to ozanimod
Ozanimod 0.5 mg
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.
Intervention: Ozanimod
Ozanimod 0.5 mg
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.
Intervention: Placebo to interferon beta-1a
Ozanimod 1 mg
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.
Intervention: Ozanimod
Ozanimod 1 mg
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.
Intervention: Placebo to interferon beta-1a
Outcomes
Primary Outcomes
Adjusted Annualized Relapse Rate (ARR) During the Treatment Period
Time Frame: 12 months
The relapse rate was based on confirmed relapses. A relapse was defined as new or worsening neurological symptoms attributable to MS and preceded by a relatively stable or improving neurological state for at least 30 days. Symptoms must have persisted for \> 24 hours and not be attributable to confounding clinical factors. Relapses were confirmed when accompanied by objective neurological worsening based on examination by the blinded evaluator, consistent with an increase of ≥ 0.5 on the overall EDSS score relative to the most recent EDSS assessment, or 2 points on one of the functional system scale scores, or 1 point on ≥ two functional system scale scores. Relapse rate was calculated as the total number of relapses divided by the total number of days in the study \* 365.25. ARR was adjusted for region (Eastern Europe vs rest of world), Baseline age, and Baseline number of gadolinium-enhancing lesions; the natural log transformation of time on study was included as an offset term.
Secondary Outcomes
- Adjusted Mean Number of New or Enlarging Hyperintense T2-Weighted Brain Magnetic Resonance Imaging (MRI) Lesions Per Scan Over 12 Months(12 month treatment period; MRI scans were assessed at Month 6 and Month 12)
- Percent Change From Baseline in Normalized Brain Volume at Month 12(Baseline to Month 12)
- Adjusted Mean Number of Gadolinium Enhancing (GdE) Brain MRI Lesions at Month 12(Month 12)
- Time to Onset of Disability Progression Confirmed After 6 Months(From first dose to the end of the 12-month treatment period)
- Time to Onset of Disability Progression Confirmed After 3 Months(From first dose to the end of the 12-month treatment period)
- Percentage of Participants Who Were T2 Lesion-Free at Month 12(Month 12)
- Percentage of Participants Who Were Gadolinium Enhancing Lesion-Free at Month 12(Month 12)
- Change From Baseline to Month 12 in Multiple Sclerosis Functional Composite (MSFC) Score Including the Low-Contrast Letter Acuity (LCLA) Test(Baseline to Month 12)
- Mean Change From Baseline in Multiple Sclerosis Quality of Life (MSQOL)-54 Physical Health Composite Summary and Mental Health Composite Summary Scores(Baseline to Month 12)
- Number of Participants With Treatment Emergent Adverse Events(From the first dose of study drug until 28 days following the last dose of study drug; mean exposure to study drug was 13.5 months for interferon beta-1a and 13.6 months for each ozanimod group.)