NCT05797740进行中（未招募）不适用
Cladribine Tablets Level of Response Predictors in Clinical Practice (CLODINA)
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany48 个研究点 分布在 6 个国家目标入组 366 人开始时间: 2023年8月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 366
- 试验地点
- 48
- 主要终点
- Time to Discontinuation of Treatment with Cladribine tablets
研究概览
简要总结
This study aims to describe participants characteristics that can predict the safety and effectiveness of cladribine tablets, as assessed by time-to-discontinuation of treatment with cladribine tablets, and to assess other patient-reported, clinical, and imaging outcomes in participants with relapsing multiple sclerosis (RMS) in the long term, in a real-world setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Adult participants, male or female patients ≥ 18 years old at index date
- •Participants must voluntarily give written informed consent form (ICF). Patients must read and fully understand the ICF
- •Participants with confirmed diagnosis of RMS at index date, diagnosed by the treating physician according to applicable clinical practice guidelines (currently McDonald 2017 criteria), with high disease activity.
- •Required historical data should be available: number of relapses in the 12 months prior to index date, DMTs taken prior to index date, date of MS diagnosis, and data of at least 1 MRI prior to index date as specified in the drug Summary of Product Characteristics (SmPC)
- •Fulfillment of the indication for treatment with cladribine tablets at index date, per standard of care in accordance with the local SmPC
- •Meeting 1 of the following criteria:
- •Prospective participants: Having been prescribed with cladribine tablets or having taken at least one dose of cladribine tablets, with enrollment date prior to the second treatment week
- •Retrospective participants: Having taken at least one dose of cladribine tablets, with enrollment date during or after the second treatment week but not more than 3 years after the first dose of cladribine tablets
排除标准
- •Contraindications to use of cladribine tablets according to the SmPC.
- •Any participant who had the first dose of cladribine tablets more than 3 years prior to enrollment
- •Any participant who is pregnant or plans to breast-feed while taking cladribine tablets, or any patient who or whose partner plans to become pregnant in Year 1 or within 6 months after the last dose in Year 2, or any participants who is unwilling or unable to use contraception per the SmPC
- •Have participated or participating in an interventional study since cladribine tablet initiation, in which participant assessment and/or treatment may be dictated by a protocol
- •Participants who, at the discretion of the Investigator, will not be able to provide reliable information for the study
研究组 & 干预措施
Single cohort
This is a single cohort study enrolling Participants with relapsing multiple sclerosis (RMS), who are prescribed treatment with cladribine tablets in routine clinical practice following the summary of product characteristics (SmPC).
干预措施: Mavenclad (Drug)
结局指标
主要结局
Time to Discontinuation of Treatment with Cladribine tablets
时间窗: Up to 48 months
次要结局
- Cumulative Cladribine Dose(Up to 48 months)
- Percentage of Participants Free From Relapse(Year 2 and Year 4)
- Percentage of Participants With Sustained Disability Progression, Improvement, or Stability Confirmed Over 6 Months as Assessed by T25FW Score(Year 1, Year 2, Year 3 and Year 4)
- Percentage of Participants With Sustained Disability Progression, Improvement, or Stability Confirmed Over 6 Months as Assessed by 9HPT Score(Year 1, Year 2, Year 3 and Year 4)
- Percentage of participants Receiving Each of The Possible Number of Annual Treatment Courses with Cladribine Tablets(Baseline, 12 months, 24 months, 36 months and 48 months)
- Proportion of Severe Relapses(Baseline, 12 months, 24 months, 36 months and 48 months)
- Percentage of Participants with an Increase and Decrease in Timed 25-Foot Walk (T25FW) Score of At Least 20% From Baseline at Year 1, 2, 3 and 4(Baseline, Year 1, Year 2, Year 3 and Year 4)
- Percentage of Participants with an Increase and Decrease in 9-Hole Peg Test (9HPT) Score of At Least 20% From Baseline at Year 1, 2, 3 and 4(Baseline, Year 1, Year 2, Year 3 and Year 4)
- Percentage of Participants With Minimal Evidence of Disease Activity (MEDA)(Year 2 and Year 4)
- Treatment Cost of Disease-Modifying Treatment (DMTs)(Up to 48 months)
- Percentage of Participants Free From Magnetic Resonance Imaging (MRI) Activity(At Year 1, Year 2, Year 3 and Year 4)
- Percentage of Participants with Minimal MRI Activity (=< 2 New T2 Lesions)(At Year 1, Year 2, Year 3 and Year 4)
- Percentage of Participants With No Evidence of Disease Activity (NEDA-3)(Year 2 and Year 4)
- Multiple Sclerosis Impact Scale (MSIS-29) Physical Domain Score, Psychological Domain Score and Total Score(Baseline, Year 1, Year 2, Year 3 and Year 4)
- Global Satisfaction, Effectiveness, Side Effects, and Convenience Domain Scores of Treatment Satisfaction Questionnaire for Medication (TSQM)(Baseline, Year 1, Year 2, Year 3 and Year 4)
- EuroQol Visual Analog Scale (EQ-VAS) Score(Baseline, Year 1, Year 2, Year 3 and Year 4)
- Number of Relapses(Baseline, 12 months, 24 months, 36 months and 48 months)
- Time From Onset of Relapse to Recovery(Up to Month 48)
- Annualized Relapse Rate (ARR)(At Year 2 and Year 4)
- Timed 25-Foot Walk (T25FW) Score(Baseline, Year 1, Year 2, Year 3 and Year 4)
- 9-Hole Peg Test (9HPT) Score(Baseline, Year 1, Year 2, Year 3 and Year 4)
- Percentage of Participants With Progressed, Improved, or Stable Disability as Assessed by Expanded Disability Status Scale (EDSS) Confirmed Over 6 Months(Year 1, Year 2, Year 3 and Year 4)
- EuroQol 5-Dimensions (EQ-5D-5L) Score(Baseline, Year 1, Year 2, Year 3 and Year 4)
研究者
研究点 (48)
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