A Phase II Study of the Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 179
- 试验地点
- 2
- 主要终点
- MRI assessment: number of unique active lesions per scan (T2/proton density and gadolinium-enhanced T1 scan analysis)
研究概览
简要总结
The primary objective of this study was to determine the safety and efficacy of teriflunomide in multiple sclerosis (MS) with relapses.
Secondary objectives were:
- To determine the effect of teriflunomide on additional magnetic resonance imaging (MRI) variables as well as clinical and quality of life measures.
- To investigate the pharmacokinetic and pharmacodynamic relationships.
详细描述
The total duration of the study period per participants was 46 weeks comprising 3 periods:
- a 4-week screening period,
- a 36-week double-blind treatment period,
- a 6-week post-treatment follow-up period.
Participants who successfully completed the double-blind treatment phase were offered the possibility to continue study treatment in the extension study LTS6048 - NCT00228163.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically confirmed multiple sclerosis [MS];
- •Expanded Disability Status Scale [EDSS] score less or equal to 6;
- •Two documented relapses in the previous 3 years, and one clinical relapse during the preceding year;
- •Screening magnetic resonance imaging [MRI] scan fulfilling the criteria for a diagnosis of MS.
排除标准
- •Clinically relevant cardiovascular, hepatic, hematologic, neurological, endocrine or other major systemic disease;
- •Pregnant or nursing woman;
- •Wish to parent children during the trial or following the trial (men and women were required to practice effective contraception during the trial and for 24 months after drug discontinuation);
- •Prior treatment with interferon [IFN], gamma-globulin, glatiramer acetate, or other noncorticosteroid immunomodulatory therapies in the 4 months prior to the trial;
- •Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment;
- •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 patient's potential participation in a clinical trial.
研究组 & 干预措施
Placebo
Placebo (for teriflunomide),
- two tablets once daily for 1 week then,
- one tablet once daily for 35 weeks.
干预措施: Placebo (placebo for teriflunomide) (Drug)
Teriflunomide 7 mg
Teriflunomide 7 mg:
- two tablets once daily for 1 week then,
- one tablet once daily for 35 weeks.
干预措施: Teriflunomide (Drug)
Teriflunomide 14 mg
Teriflunomide 14 mg:
- two tablets once daily for 1 week then,
- one tablet once daily for 35 weeks.
干预措施: Teriflunomide (Drug)
结局指标
主要结局
MRI assessment: number of unique active lesions per scan (T2/proton density and gadolinium-enhanced T1 scan analysis)
时间窗: 36 weeks
The number of unique active lesions per scan was calculated by dividing the sum of unique newly active lesions and unique persistently active lesions observed on treatment by the number of scans performed on treatment. Unique newly active lesions were all unique T1 and T2 lesions identified, one or more times, in a scan but not in the previous scan and, that had not been classified as unique newly active in any previous scan. Unique persistently active lesions were all unique T1 and T2 lesions identified, one or more times, in a scan and also in the previous scan.
Overview of Adverse Events [AE]
时间窗: from first study drug intake up to 6 weeks after last intake or entry in the extension study, whichever came first
AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.
次要结局
- MRI assessment: Number of participants with no new lesions(36 weeks)
- Number of participants with progression on Expanded Disability Status Scale [EDSS](36 weeks)
- MRI assessment: number of T2-lesions per scan(36 weeks)
- MRI assessment: Change from baseline in T2 burden of disease(36 weeks)
- MRI assessment: number of T1-enhancing lesions per scan(36 weeks)
- Number of participants with MS relapse confirmed by Scripps Neurological Rating Scale [NRS] and EDSS scores.(36 weeks)