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临床试验/NCT03933215
NCT03933215已完成不适用

Cladribine Tablets: Observational Evaluation of Effectiveness and PROs in Suboptimally Controlled Patients Previously Taking Injectable DMDs for RMS (CLICK-MS)

EMD Serono Research & Development Institute, Inc.18 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年5月21日最近更新:
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适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
18
主要终点
Annualized Relapse Rate (ARR)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To evaluate the effectiveness, patient-reported outcomes (PROs) and safety of cladribine tablets in participants with relapsing forms of multiple sclerosis (RMS) including relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis (aSPMS),who transition to cladribine tablets after suboptimal response to any injectable 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

  • •Male or female participants greater than or equal to (>=)18 years
  • •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
  • •Had received their last previous injectable disease-modifying drug (DMD) for at least 3 months
  • •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
  • •In the opinion of the Investigator, experienced suboptimal response (lack of effectiveness, intolerability, poor adherence) to injectable DMD treatment

排除标准

  • •Have been previously treated with cladribine in any dosing form
  • •Transitioning from previous injectable 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 the cladribine treatment period

研究组 & 干预措施

Cladribine

干预措施: Cladribine (Drug)

结局指标

主要结局

Annualized Relapse Rate (ARR)

时间窗: Baseline (Month 0) up to 24 Months

The qualifying relapse is the occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis (MS) (for more than \[\>\] 24 hours, no fever, infection, injury, adverse events (AEs), and preceded by a stable or improving neurological state for more than or equal to \[\>=\] 30 days).

次要结局

  • Number of Previous Disease-Modifying Drugs (DMD) Received for Multiple Sclerosis (MS) at Baseline(At Baseline)
  • Number of Participants Who Received At Least One Concomitant Medication(Baseline up to Month 24)
  • Percentage of Participants Who Discontinued 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)
  • 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) 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 Percent 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 Percent 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 Percent 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 Percent 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 Cladribine as Assessed by Modified Versions of the Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ)(Baseline (Month 0) and Months 1, 2, 13 and 14)
  • Percentage of Participants Who Experienced Relapse at Months 12 and 24(Months 12 and 24)
  • Annualized Relapse Rate (ARR) at Month 12(At Month 12)
  • Percentage of Participants Who Experienced Relapse Associated With Hospitalization(Months 12 and 24)
  • Annualized Relapse Rate (ARR) Associated With Hospitalization at Months 12 and 24(Months 12 and 24)
  • Percentage of Participants Who Experienced Relapse Associated With Glucocorticoid Use(Months 12 and 24)
  • Annualized Relapse Rate (ARR) Associated With Glucocorticoid Use at Months 12 and 24(Months 12 and 24)
  • Number of Doses Received by Participants as Per United States Prescribing Information(Baseline (Month 0) up to 24 Months)
  • Percentage of Participants With Treatment Compliance as Per United States Prescribing Information(Baseline (Month 0) up to 24 Months)
  • 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)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (18)

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