Long-term Extension of the Multinational, Double-blind, Placebo Controlled Study EFC6049 (HMR1726D/3001) to Document the Safety of Two Doses of Teriflunomide (7 and 14 mg) in Patients With Multiple Sclerosis With Relapses
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 742
- 试验地点
- 116
- 主要终点
- Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
The primary objective of this study was to document the long-term safety and tolerability of teriflunomide in Multiple Sclerosis (MS) participants with relapse.
The secondary objective was to document the long-term efficacy on disability progression, relapse rate and Magnetic Resonance Imaging (MRI) parameters.
详细描述
Participants completing the EFC6049 (HMR1726D/3001) study were given the opportunity to continue in the extension study;
- participants receiving teriflunomide 7 mg or 14 mg were blindly maintained on the same dose of teriflunomide.
- participants receiving placebo were randomized at a 1:1 ratio to teriflunomide 7 mg or 14 mg.
The study period per participant was broken down as follows:
- Double-blind treatment: up to a maximum of 288 weeks or until teriflunomide was commercially available in the country where participant lived,
- Post-washout follow-up: 4 weeks after last treatment intake. No post-washout follow up if participant continued on teriflunomide treatment by obtaining its commercial form after end of the study.
The total duration of the extension was 292 weeks (about 6 years) from the first participant enrolled or until teriflunomide is commercially available in the country where participant lived.
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
- Double (Participant, Investigator)
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
- •Participant who completed the previous double-blind placebo-controlled study EFC6049 and who did not meet criteria for treatment withdrawal.
- •Willingness to participate in a long-term safety/efficacy trial.
排除标准
- •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
Placebo/Teriflunomide 7 mg
Participants who completed treatment of placebo (for teriflunomide) tablet once daily (QD) for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
干预措施: Teriflunomide (HMR1726) (Drug)
Teriflunomide 7 mg/7 mg
Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
干预措施: Teriflunomide (HMR1726) (Drug)
Placebo/Teriflunomide 14 mg
Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
干预措施: Teriflunomide (HMR1726) (Drug)
Teriflunomide 14 mg/14 mg
Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
干预措施: Teriflunomide (HMR1726) (Drug)
结局指标
主要结局
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
时间窗: Baseline (LTS6050) up to 28 days after last dose of study drug up to 450 weeks
Adverse event (AE) was defined as any untoward medical occurrence in a participant who received investigational medicinal product (IMP) without regard to possibility of causal relationship with this treatment. TEAEs: AEs that developed or worsened or became serious during on-treatment period which was defined as the period from the time of first dose of study drug (in LTS6050) up to 4 weeks (28 days) after last dose of study drug. Serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included both serious and non-serious AEs.
次要结局
- Time to 12 Week Sustained Disability Progression (DP): Kaplan-Meier Estimates of the Rate of DP(Up to 10.8 years (EFC6049: 108 weeks + LTS6050: 450 weeks))
- Time to 24 Week Sustained Disability Progression (DP): Kaplan-Meier Estimates of the Rate of DP(Up to 10.8 years (EFC6049: 108 weeks + LTS6050: 450 weeks))
- Percentage of Participants Free of Sustained Disability Progression (DP)(Up to 10.8 years since EFC6049 randomization (EFC6049: 108 weeks + LTS6050: 450 weeks))
- Annualized MS Relapse Rate (ARR): Poisson Regression Estimates(Up to 8 years since LTS6050 randomization)
- Magnetic Resonance Imaging (MRI) Assessment: Change From Baseline in Total Volume of Abnormal Lesions (Burden of Disease [BOD]) at Week 192 Since LTS6050 Randomization(Baseline, Week 192)