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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 1,346
- 试验地点
- 223
- 主要终点
- Adjusted Annualized Relapse Rate (ARR) During the Treatment Period
研究概览
简要总结
The purpose of this study is to determine whether ozanimod is effective in the treatment of relapsing multiple sclerosis (RMS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Multiple sclerosis as diagnosed by the revised 2010 McDonald criteria
- •EDSS score between 0 and 5.0 at baseline
排除标准
- •Primary progressive multiple sclerosis
研究组 & 干预措施
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.
干预措施: Interferon beta-1a (Drug)
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.
干预措施: Placebo to ozanimod (Drug)
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.
干预措施: Ozanimod (Drug)
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.
干预措施: Placebo to interferon beta-1a (Drug)
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.
干预措施: Ozanimod (Drug)
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.
干预措施: Placebo to interferon beta-1a (Drug)
结局指标
主要结局
Adjusted Annualized Relapse Rate (ARR) During the Treatment Period
时间窗: 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.
次要结局
- 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.)