Cladribine Tablets: Observational Evaluation of Effectiveness and PROs in Suboptimally Controlled Patients Previously Taking Oral or Infusion DMDs for RMS (MASTER-2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 291
- 试验地点
- 66
- 主要终点
- Annualized Relapse Rate (ARR)
研究概览
简要总结
To evaluate the effectiveness, safety and Patient-Reported Outcomes (PROs) of cladribine tablets in participants with RMS including relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis (aSPMS), who transition to cladribine tablets after suboptimal response to any oral or infusion Disease-Modifying Drugs (DMDs) approved in the United States (US) for RMS in a real-world-setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Signed informed consent
- •Have diagnosis of RMS, including RRMS and aSPMS, and satisfy the approved indication for cladribine tablets as per United States Prescribing Information (USPI)
- •Have time since diagnosis of RMS of at least 12 months
- •In the opinion of the investigator, experienced suboptimal response (lack of effectiveness, intolerability, poor adherence) to oral or infusion DMD treatment other than cladribine tablets
- •Had received their last previous oral DMD for at least 1 month or at least 1 dose of their last previous infusion DMD
- •Have decided to initiate treatment with cladribine tablets during routine clinical care
- •Meet criteria as per the approved USPI
- •Have access to a valid e-mail address
排除标准
- •Have been previously treated with cladribine in any dosing form (intravenous, subcutaneous, or oral)
- •Transitioning from previous oral DMD solely for administrative reasons such as relocation
- •Have comorbid conditions that preclude participation
- •Have any clinical condition or medical history noted as contraindication on USPI
- •Are currently participating in an interventional clinical trial
- •Pregnant or breastfeeding women, women who plan to become pregnant or men whose partner plans to become pregnant during study the cladribine treatment period
研究组 & 干预措施
Cladribine Tablets
No intervention will be administered as a part of this study. Participants who had decided prior to enrollment to transition from any oral or infusion DMD to treatment with cladribine tablets under routine clinical care and who meet all eligibility criteria will receive an initial treatment course with cladribine tablets in Year 1 and are planned to receive a second course in Year 2, as per the approved United States Prescribing Information (USPI). Data sources for this study will include data extracts from participants' medical records performed by site personnel as well as questionnaires directly filled out by participants.
干预措施: Cladribine Tablets (Drug)
结局指标
主要结局
Annualized Relapse Rate (ARR)
时间窗: From first dose of cladribine tablets up to 24 months
A relapse was defined as per routine clinical practice as determined by the investigator. As a guide, relapse may be defined as exacerbation of symptoms that occur over a minimum of 24 hours and separated from a previous attack by at least 30 days, in the absence of fever or infection. ARR was calculated as the total number of reported relapses in the 24 months after treatment divided by the days on study corresponding to relapse information and multiplied by 365.25.
次要结局
- Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24(Baseline (Month 0), Month 6, 12 and 24)
- Change From Baseline in 36-Item Short Form Health Survey (SF-36) Domain Score at Month 6, 12 and 24(Baseline (Month 0), Month 6, 12 and 24)
- Change From Baseline in Modified Fatigue Impact Scale - 5-item Version (MFIS-5) Total Score at Month 6, 12 and 24(Baseline (Month 0), Month 6, 12 and 24)
- Change From Baseline in 7-Item Beck-Depression Inventory-Fast Screen (BDI-FS) Total Score at Month 6, 12 and 24(Baseline (Month 0), Month 6, 12 and 24)
- Change From Baseline in Percentage of Work Time Missed Assessed by 6-Item Work Productivity Activity Impairment - Multiple Sclerosis (WPAI-MS) Score at Month 6, 12 and 24(Baseline (Month 0), Month 6, 12 and 24)
- Change From Baseline in Percentage of Impairment While Working Assessed by 6-Item Work Productivity Activity Impairment - Multiple Sclerosis (WPAI-MS) Score at Month 6, 12 and 24(Baseline (Month 0), Month 6, 12 and 24)
- Change From Baseline in Percentage of Overall Work Impairment Assessed by 6-Item Work Productivity Activity Impairment - Multiple Sclerosis (WPAI-MS) Score at Month 6, 12 and 24(Baseline (Month 0), Month 6, 12 and 24)
- Change From Baseline in Percentage of Activity Impairment Assessed by 6-Item Work Productivity Activity Impairment- Multiple Sclerosis (WPAI-MS) Score at Month 6, 12 and 24(Baseline (Month 0), Month 6, 12 and 24)
- Change From Baseline in Patient Determined Disease Steps (PDDS) Scale Total Score at Month 6, 12 and 24(Baseline (Month 0), Month 6, 12 and 24)
- Number of Participants With Adherence to Treatment as Assessed by Modified Versions of the Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ)(Month 1, 2, 13 and 14)
- Number of Participants Who Experienced Relapse(Over the 12-month and 24-month period)
- Percentage of Participants With Relapse Associated With Hospitalization(Over the 12-month period, 13th to 24th month and over the 24 month period.)
- Annualized Relapse Rate (ARR) Associated With Hospitalization at Months 12 and 24(Month 12 and Month 24)
- Percentage of Participants With Relapse Associated With Glucocorticoid Use(Over the 12-month period, 13th to 24th month and over the 24 month period.)
- Annualized Relapse Rate (ARR) Associated With Glucocorticoid Use at Months 12 and 24(Months 12 and 24)
- Number of Previous Disease-Modifying Drugs (DMD) Received for Multiple Sclerosis (MS) at Baseline(At Baseline (Month 0))
- Percentage of Participants Who Discontinued Cladribine Tablets(Baseline (Month 0) up to 24 Months)
- Number of Participants With Reason for Discontinuation of Cladribine Tablets(Baseline (Month 0) up to 24 Months)
- Elapsed Time to Discontinuation After First Dose of Cladribine Tablets(Baseline (Month 0) up to 24 Months)
- Number of Doses Received by Participants as Per United States Prescribing Information(Baseline (Month 0) up to 24 Months)
- Total Planned Doses Received by Participants as Per United States Prescribing Information(Baseline (Month 0) up to 24 Months)
- Percentage of Participants With Subsequent Treatment Chosen Following Discontinuation of Cladribine Tablets(Baseline (Month 0) up to 24 Months)
- Number of Participants With At Least One Concomitant Medication(Baseline (Month 0) up to 24 Months)
- Annualized Relapse Rate (ARR)(Up to 24 Months prior Baseline (Month 0))
- Number of Participants With Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and Adverse Events of Special Interest (AESIs)(Baseline (Month 0) up to 24 months)