NCT02099370已完成不适用
A Single-center Prospective Measurement of Adherence to Treatment With Tecfidera™ in Multiple Sclerosis Patients.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- adherence rates to Tecfidera
研究概览
简要总结
The investigators are measuring the adherence rates of an oral MS drug that is to be administered twice-daily. The investigators would like to observe any patterns that might indicate factors that greatly affect adherence.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information [PHI]).
- •Aged 18 at the time of informed consent.
- •Must have a relapsing form of MS.
- •Male subjects and female subjects of child-bearing potential (including female subjects who are not post-menopausal for at least 1 year) must be willing to practice effective contraception (as defined by the investigator) during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
排除标准
- •Progressive form of MS
- •History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
- •Female subjects considering becoming pregnant while in the study.
- •Female subjects who are currently pregnant or breast-feeding.
- •Unwillingness or inability to comply with the requirements of the protocol including the presence of any conditional (physical, mental or social) that is likely to affect the subject's ability to comply with the protocol.
- •Any other reason that, in opinion of the Investigator and/or the Sponsor, the subject is determined to be unsuitable for enrollment in this study.
结局指标
主要结局
adherence rates to Tecfidera
时间窗: over one year
次要结局
未报告次要终点
研究者
Derrick Scott Robertson
MD, Multiple Sclerosis Center Director
University of South Florida
研究点 (1)
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