A Multicenter, Open-label Phase IV Study to Evaluate Whether a Medication Event Monitoring System (MEMS®) Can Improve Adherence to Tecfidera® (Delayed-release Dimethyl Fumarate) Treatment in Multiple Sclerosis Patients.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Biogen
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Overall Adherence Rates at Month 12: Arm 3 vs. Arm 1
研究概览
简要总结
The primary objective of the study is to determine whether a Medication Event Monitoring System (MEMS®) cap with a liquid crystal display (LCD) reader (a "smart" cap) along with additional patient counseling intervention (Arm 3) can improve adherence to dimethyl fumarate (DMF) treatment in Multiple Sclerosis (MS) patients as compared to a MEMS cap without an LCD reader (a "standard" cap) and no patient counseling intervention (standard of care, Arm 1) at Month 12.
The secondary objectives of this study in this study population are: to determine if data display on a smart MEMS cap with an LCD reader (Arm 2) can improve adherence as compared to a standard MEMS cap without an LCD reader (Arm 1) at Month 12; to determine whether the addition of patient counseling intervention based on MEMS data (Arm 3), or data display from a MEMS cap with an LCD reader (Arm 2) can improve adherence compared to standard MEMS cap without an LCD reader (Arm 1) at Month 6; to assess persistence and compliance at Months 6 and 12 for all arms; to assess the association between adherence and patient- reported outcomes (PROs) for all arms including Multiple Sclerosis Impact Scale (MSIS-29), and the Work Productivity and Activity Impairment Questionnaire (WPAI): MS v2.0.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •The candidate is a DMF-naïve patient
- •Have a diagnosis of relapsing forms of MS and satisfy the approved therapeutic indication for DMF
- •Have a recent (i.e., within the previous 6 months) complete blood count with results that do not preclude the patient's participation in the study, in the judgment of the Investigator
排除标准
- •Have comorbid conditions that preclude participation in the study, as determined by the Investigator
- •History of severe allergic or anaphylactic reactions or known drug hypersensitivity
- •Are participating, planning to participate, or have participated in the Tecfidera QuickStart Program
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
Arm 1: Standard MEMS Cap
A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
干预措施: dimethyl fumarate (Drug)
Arm 1: Standard MEMS Cap
A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
干预措施: Medication Event Monitoring System (MEMS) (Device)
Arm 2: Smart MEMS Cap
A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings). Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
干预措施: dimethyl fumarate (Drug)
Arm 2: Smart MEMS Cap
A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings). Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
干预措施: Medication Event Monitoring System (MEMS) (Device)
Arm 3: Smart MEMS Cap + Counseling
A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
干预措施: dimethyl fumarate (Drug)
Arm 3: Smart MEMS Cap + Counseling
A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
干预措施: Medication Event Monitoring System (MEMS) (Device)
Arm 3: Smart MEMS Cap + Counseling
A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
干预措施: Adherence counseling (Behavioral)
结局指标
主要结局
Overall Adherence Rates at Month 12: Arm 3 vs. Arm 1
时间窗: Month 12
Adherence is defined as the proportion of time on treatment over the study observation time period, times the proportion of actual DMF doses taken per label according to feedback from MEMS data over the total expected DMF doses per label during a treatment period.
次要结局
- Overall Adherence Rates at Month 12: Arm 2 vs. Arm 1(Month 12)
- Overall Adherence Rates at Month 6: Arm 3 vs. Arm 1(Month 6)
- Overall Adherence Rates at Month 6: Arm 2 vs. Arm 1(Month 6)
- Persistence Rates at Months 6 and 12(Month 6, Month 12)
- Compliance Rates at Month 6 and 12(Month 6, Month 12)
- Multiple Sclerosis Impact Scale (MSIS-29)(Month 6, Month 12)
- Work Productivity and Activity Impairment Questionnaire (WPAI: MS Version 2.0)(Month 6, Month 12)