Oral CLADribine in Patients That Change From First-line Disease Modifying Treatments for Multiple Sclerosis: a pROspective effectivenesS and Safety Study (CLAD CROSS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 256
- 试验地点
- 61
- 主要终点
- Change in Annualized Relapse Rate (ARR) Between the Pre-Baseline 12-Month Period (Baseline) and Over the 12 Months Period Before the End of Study Follow-Up (2 Years)
研究概览
简要总结
The main aim was to study in the real world setting the effectiveness of Cladribine tablets in terms of Annualized Relapse Rate (ARR) and disability progression, in participants who switched from a first line Disease Modifying Drug (DMD) (Interferons, Glatiramer Acetate, Teriflunomide, (Dymethyl fumarate) [DMF]) to treatment with Cladribine tablets in routine clinical practice.
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
- •Participants with confirmed diagnosis of RRMS diagnosed by the treating physician according to applicable clinical practice guidelines -(currently McDonald 2017 criteria), with high disease activity
- •Participants should have been treated with the same first-line DMD (Interferons, Glatiramer Acetate, Teriflunomide, DMF) and at a stable dose for at least one year prior to switch to Cladribine tablets and should have been prescribed Cladribine tablets, according to the decision of the treating physician, prior to enrollment in the study. Any washout period and/or washout methods required before switching (such as elimination of Teriflunomide) must have been conducted, according to the decision of the treating physician
- •Required history data should be available: Multiple Sclerosis (MS) data for the 12-months pre-baseline period (annualized relapse rate); MS Medication History (prior DMDs)
- •Fulfilment of the criteria for treatment with Cladribine tablets per standard of care in accordance with the local Summary of Product Characteristics (SmPC)
排除标准
- •Contraindications to use of cladribine tablets according to the SmPC
- •Participants with history of alcohol or drug abuse that could potentially interfere with their participation in the study
- •Participants that have received Cladribine in the past
- •Concurrent participation in an investigational study in which participant assessment and/or treatment may be dictated by a protocol
研究组 & 干预措施
Cladribine
干预措施: Cladribine (Drug)
结局指标
主要结局
Change in Annualized Relapse Rate (ARR) Between the Pre-Baseline 12-Month Period (Baseline) and Over the 12 Months Period Before the End of Study Follow-Up (2 Years)
时间窗: 12-months pre-baseline (Baseline) and 12 Months Prior to End of Study follow up (2 years)
ARR defined as the number of relapses per year. A relapse was defined as the appearance of new symptoms or the exacerbation of pre-existing symptoms that were attributed to Multiple Sclerosis (MS) and occurred over a minimum of 24 hours and separated from a previous attack by at least 30 days, in the absence of fever or infection. Baseline ARR was defined as the total number of relapses reported in the last 12 months prior to Cladribine treatment. ARR 12-months prior to End Of Study was calculated as the sum of the number of MS relapses reported at Visit 3 and Visit 4 divided by the number of days between Visit 4 date and Visit 2 date and multiplied by 365.25. For a change from baseline, 95 percent (%) Confidence Interval (CI) for the difference were presented together with summary statistics. These CIs were included as a descriptive measure of effect.
次要结局
- Change in ARR Between the Pre-Baseline 12-Month Period (Baseline) and Over the 12 Months Period After the Start of Cladribine (1 Year)(12-month pre-baseline period (baseline) and over the 12 months period after start of Cladribine treatment (1 year))
- Percentage of Participants With 6-Month Disability Progression Measured With Expanded Disability Status Scale (EDSS)(At EOS (24 months follow-up))
- Percentage of Participants With Overall 6-Month Disability Progression Measured With EDSS, Timed 25 Foot Walk (T25FW) or 9 Hole Peg Test (9HPT)(At EOS (24 months follow-up))
- Percentage of Participants With 6-Month Disability Improvement Measured With EDSS(At EOS (24 months follow-up))
- Percentage of Participants With Overall 6-Month Disability Improvement Measured With EDSS, Timed 25 Foot Walk (T25FW) or 9 Hole Peg Test(9HPT)(At EOS (24 months follow-up))
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)(From start of study up to 2 years)
- Quality of Life as Assessed by Multiple Sclerosis Impact Scale (MSIS-29) Score: Physical and Psychological Impact(Baseline, Months 12 and 24)
- Quality of Life as Assessed by EuroQol Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D-3L)(Baseline, Months 12 and 24)
- Treatment Satisfaction as Assessed by Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM v1.4) Scale(Months 6, 12, 18 and 24)
- Number of Participants With Treatment Adherence(Up to Month 24)