A Prospective, Single-Arm, Clinical-Setting Study to Describe Efficacy, Tolerability and Convenience of Teriflunomide Treatment Using Patient Reported Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 1,001
- 试验地点
- 169
- 主要终点
- Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 - Assessment of Global Satisfaction Subscale Score With Teriflunomide Treatment at Week 48
研究概览
简要总结
Primary Objective:
To describe efficacy, tolerability and convenience of teriflunomide treatment through the evaluation of Participant Reported Outcomes (PROs).
Secondary Objectives:
To describe disease progression using PROs. To describe clinical outcomes (ie, treated relapses) in teriflunomide treated participant.
To describe the change in cognition in teriflunomide treated participants. To describe safety of teriflunomide in participant treated (based on adverse events reporting).
To describe adherence and persistence to teriflunomide treatment. To describe quality of life, activity and leisure over the period of teriflunomide treatment.
To compare Participant Determined Disease Steps (PDDS) and Expanded Disability Status Scale (EDSS) in assessing Multiple Sclerosis (MS) disease progression.
详细描述
The total duration of the study per participant was up to 50 or 54 weeks (if accelerated elimination procedure performed):
Screening: up to 2 weeks Teriflunomide treatment: 48 weeks Accelerated elimination procedure: 4 weeks when performed
An accelerated elimination procedure at any time after discontinuation of teriflunomide treatment was possible and it was particularly recommended for women of child-bearing potential.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Teriflunomide
Teriflunomide 14 mg or 7 mg according to local labelling once daily (QD) orally for 48 weeks.
干预措施: Teriflunomide (Drug)
结局指标
主要结局
Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 - Assessment of Global Satisfaction Subscale Score With Teriflunomide Treatment at Week 48
时间窗: Week 48
TSQM version 1.4 is a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. It comprises of 14 items assessing the following 4 domains: effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions:12-14). Primary outcome was the global satisfaction score. The score of the corresponding item was added based on the algorithm to create a score of 0 to 100. Higher score indicated greater satisfaction in that domain.
次要结局
- Change From Baseline in Multiple Sclerosis Performance Scale (MSPS) Score at Week 24 and Week 48(Baseline, Week 24, Week 48)
- Overview of Adverse Events (AEs)(From first study drug intake up to 112 days after last intake for participant with no AEP or to last AEP follow up visit for participants with AEP)
- Change From Baseline in Stern Leisure Activity Scale at Week 48(Baseline, Week 48)
- Change From Baseline in TSQM Scores in Participants Switching From Another Disease Modifying Therapy (DMT) at Week 4 and Week 48(Baseline, Week 4, Week 48)
- Change From Week 4 in TSQM Scores in Naïve Participants to Week 48(Week 4, Week 48)
- Change From Baseline in Disease Progression Using Patient Determined Disease Steps (PDDS) Score at Week 48(Baseline, Week 48)
- Annualized Treated Relapse Rate(Baseline up to end of treatment (up to Week 48))
- Time to Relapse: Kaplan-Meier Estimates of the Probability of Treated Relapse at Week 4, Week 24 and Week 48(Baseline up to end of treatment (up to Week 48))
- Change From Baseline in Cognition Measured by Symbol Digit Modalities Test (SDMT) Score at Week 48(Baseline, Week 48)
- Duration of Teriflunomide Treatment Exposure(Baseline up to end of treatment (up to Week 48))
- Expanded Disability Status Scale (EDSS) Score at Baseline and Week 48(Baseline, Week 48)
- Percentage of Participants With Treatment Compliance of ≥80% During the Study Treatment Period(Baseline up to end of treatment (up to Week 48))
- Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Score at Week 48(Baseline, Week 48)