NCT00228163已完成2 期
Extension of Protocol HMR1726D/2001, A Phase II Study of the Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 147
- 试验地点
- 16
- 主要终点
- Number of patients with adverse events
研究概览
简要总结
The primary objective is to assess the long-term safety of teriflunomide in multiple sclerosis subjects. The secondary objective is to assess the long-term efficacy.
详细描述
Subjects completing the HMR 1726D/2001 study are given the opportunity to continue or switch to teriflunomide for 528 weeks or until teriflunomide is commercially available in the country where patient lives;
- subjects on Teriflunomide 7 mg or 14 mg continue on the same dose of teriflunomide.
- subjects on placebo are randomized to teriflunomide 7 mg or 14 mg.
The total study period per subject is 532 weeks or until teriflunomide is commercially available in the country where patient lives, broken up as follows:
- Treatment: 528 weeks or until teriflunomide is commercially available in the country where patient lives,
- Post-washout follow-up: 4 weeks after last treatment intake.
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
- None
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
- •Satisfactorily completion of HMR1726D/2001 study with respect to safety.
- •If female subject, non-childbearing potential or child bearing potential with adequate contraception.
- •Consent to practice/maintain adequate means of contraception throughout the study and for 24 months after the discontinuation of treatment.
- •Clinically definite Multiple Sclerosis (MS) as established on entry into HMR1726D/2001 study.
- •Extended Disability Status Score(EDSS) between 0 and 6 inclusively, when the subject entered HMR1726D/2001 study.
- •Magnetic Resonance Imaging (MRI) criteria must continue to support the diagnosis of clinically definite MS.
- •Willingness to participate in a long-term safety and efficacy trial.
排除标准
- •Subject who did not complete HMR 1726D/2001 study for safety reasons.
- •Subject who developed clinically relevant cardiovascular, hepatic, endocrine or other major disease.
- •Pregnancy.
- •Breast-feeding.
- •Wish to parent.
- •Likelihood of requiring treatment during the study period with drugs not permitted.
- •Disallowed therapies such asw immunomodulators, immunosuppressants.
- •Recent history of drug or alcohol abuse.
- •Liver function impairment.
- •Abnormal mental conditions.
研究组 & 干预措施
Teriflunomide 7 mg
Experimental
干预措施: teriflunomide (HMR1726) (Drug)
Teriflunomide 14 mg
Experimental
干预措施: teriflunomide (HMR1726) (Drug)
结局指标
主要结局
Number of patients with adverse events
时间窗: Up to a maximum of 532 weeks (4 weeks after last treatment intake) or until teriflunomide is commercially available in the country where patient lives
次要结局
- Burden of disease : Change from baseline in the volume of abnormal brain tissue as measured by brain Magnetic Resonance Image (MRI)(528 weeks or until teriflunomide is commercially available in the country where patient lives)
- Change from baseline in subject reported fatigue as assessed by the Fatigue Impact Scale (FIS)(528 weeks or until teriflunomide is commercially available in the country where patient lives)
- Annualized relapse rate (number of relapses per patient-year)(528 weeks or until teriflunomide is commercially available in the country where patient lives)
- Change from baseline in Kurtzke Expanded Disability Status Scale (EDSS) score(528 weeks or until teriflunomide is commercially available in the country where patient lives)
- Change from baseline in Multiple Sclerosis Functional Composite (MSFC) score(528 weeks or until teriflunomide is commercially available in the country where patient lives)
- Change from baseline in Multiple Sclerosis Quality of Life Questionnaire-54 (MSQoL-54) score(528 weeks or until teriflunomide is commercially available in the country where patient lives)
研究者
研究点 (16)
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