A Multi-center Double-blind Parallel-group Placebo-controlled Study of the Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 1,169
- 试验地点
- 193
- 主要终点
- Core Treatment Period: Annualized Relapse Rate (ARR): Poisson Regression Estimate
研究概览
简要总结
The primary objective of the study was to assess the effect of two doses of teriflunomide, in comparison to placebo, on the frequency of multiple sclerosis (MS) relapses in participants with relapsing MS.
Key secondary objective was to assess the effect of the two doses of teriflunomide, in comparison to placebo, on disability progression.
Other secondary objectives were:
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To assess the effect of the two doses of teriflunomide in comparison to placebo on:
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Fatigue;
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Health-related quality of life, a measure of the impact of the participant's health on his or her overall well being.
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To evaluate the safety and tolerability of teriflunomide.
详细描述
The study consists of:
- A core treatment period: Teriflunomide 7 mg or Teriflunomide 14 mg or placebo was administered in double-blind fashion until a fixed common end date which was approximately 48 weeks after randomization of the last participant.
- An extension treatment period: the highest dose of teriflunomide was administered in open-label fashion to participants who successfully complete the core treatment period and wish to continue.
The overall treatment period was followed by a 4-week elimination follow-up period.
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
- Triple (Participant, 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
- •Relapsing multiple sclerosis,
- •Two relapses in prior 2 years or one relapse in prior year.
排除标准
- •Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease,
- •Significantly impaired bone marrow function or, significant anemia, leukopenia or thrombocytopenia,
- •Pregnant or nursing woman,
- •Alcohol or drug abuse,
- •Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate,
- •Human immunodeficiency virus (HIV) positive,
- •Any known condition or circumstance that would prevent, in the investigator's opinion, compliance or completion of the study.
- •The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
研究组 & 干预措施
Teriflunomide 7 mg / 14 mg
Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
干预措施: Teriflunomide (Drug)
Teriflunomide 14 mg / 14 mg
Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
干预措施: Teriflunomide (Drug)
Placebo / Teriflunomide 14 mg
Core treatment period: Placebo (for teriflunomide) once daily. Extension treatment period: Teriflunomide 14 mg once daily.
干预措施: Placebo (Drug)
Placebo / Teriflunomide 14 mg
Core treatment period: Placebo (for teriflunomide) once daily. Extension treatment period: Teriflunomide 14 mg once daily.
干预措施: Teriflunomide (Drug)
结局指标
主要结局
Core Treatment Period: Annualized Relapse Rate (ARR): Poisson Regression Estimate
时间窗: Core treatment period between 48 - 152 weeks depending on time of enrollment
ARR is obtained from the total number of confirmed relapses that occurred during the treatment period divided by the sum of treatment durations. Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in Expanded Disability Status Scale (EDSS) score or Functional System scores. To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as "offset" variable; treatment group, region of enrollment and baseline EDSS stratum as covariates).
次要结局
- Core Treatment Period: Change From Baseline to Week 48 in Short Form Generic Health Survey - 36 Items (SF-36) Summary Scores(Baseline (before randomization), Week 12, Week 24 and Week 48)
- Core Treatment Period: Change From Baseline to Last Visit in Short Form Generic Health Survey - 36 Items (SF-36) Summary Scores(Baseline (before randomization) and up to Week 152)
- Extension Treatment Period: Overview of Treatment Emergent Adverse Events (TEAE)(From first intake of study drug in extension treatment period up to 28 days after the last intake in the extension treatment period)
- Core Treatment Period: Time to Disability Progression(Core treatment period between 48 - 152 weeks depending on time of enrollment)
- Core Treatment Period: Time Without Relapse(Core treatment period between 48 - 152 weeks depending on time of enrollment)
- Core Treatment Period: Change From Baseline to Week 48 in EDSS Total Score(Baseline (before randomization), Week 12, Week 24, Week 36 and Week 48)
- Core Treatment Period: Change From Baseline to Week 48 in Fatigue Impact Scale (FIS) Total Score(Baseline (before randomization), Week 12, Week 24 and Week 48)
- Core Treatment Period: Change From Baseline to Last Visit in Fatigue Impact Scale (FIS) Total Score(Baseline (before randomization) and up to Week 152)
- Core Treatment Period: Overview of Adverse Events(From first study drug intake up to 112 days after last intake in the core treatment period or up to first intake in the extension treatment period, whichever occurred first)
- Extension Treatment Period: Time to Disability Progression(Core treatment period (maximum: 173 weeks) and Extension treatment period (maximum: 174 weeks))
- Extension Treatment Period: ARR: Poisson Regression Estimate(Extension treatment period (Maximum: 174 weeks))