A Prospective, Observational Study of Bafiertam Evaluating Persistence on Treatment, Safety, Tolerability, and Effectiveness in Routine Clinical Practice.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 10
- 主要终点
- Percentage of participants on treatment with Bafiertam at 1 Year.
研究概览
简要总结
This is an open-label, multicenter, observational study of the adherence of patients with relapsing-remitting multiple sclerosis (RRMS) prescribed Bafiertam (monomethyl fumarate) as their treatment.
详细描述
Monomethyl fumarate (MMF) is the active metabolite of the fumarate class of drugs used for the treatment of RRMS. Bafiertam is a formulation of MMF and does not require enzymatic conversion after oral administration. Adult participants with a diagnosis of RRMS who have been receiving continuous treatment with Bafiertam monotherapy per the approved product label for no more than 3 months (90 days) are eligible to enroll in the study. Their satisfaction with Bafiertam treatment will be assessed using a 9-Item Treatment Satisfaction Questionnaire for Medication (TSQM-9). To be included in the study, patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Male or non-pregnant female aged 18 years and older.
- •Participants diagnosed with Relapsing forms of multiple sclerosis R(RMS) and satisfy the approved therapeutic indication for Bafiertam per the approved product labeling.
- •Participants may enroll if they are within 90 days of initiating therapy with Bafiertam.
- •Female participants of childbearing potential must practice effective contraception from Day -1 and be willing and able to continue contraception for the duration of the study.
- •Willing and able to sign the informed consent form (ICF) approved by the Institutional Review Board (IRB).
- •Willing and able to complete all the study procedures and communicate meaningfully with study personnel.
排除标准
- •Known hypersensitivity to fumarates including dimethyl fumarate, Tecfidera, and/or diroximel fumarate (Vumerity) or Bafiertam.
- •Participated in another clinical trial within 30 days, suffered or still recovering from a medically significant event of surgery within 30 days, or previously participated in a clinical study with a similar investigational product.
结局指标
主要结局
Percentage of participants on treatment with Bafiertam at 1 Year.
时间窗: 12 months
Percentage of participants on treatment with Bafiertam at 1 Year.
次要结局
- Treatment Satisfaction Questionnaire for Medication (TSQM-9)(12 months)
- Number of Participants with Adverse Events (AEs) Leading to Treatment Discontinuation.(12 months)
- Percentage of Participants on Treatment with Bafiertam at 6 months(6 months)