A Study of Suboptimally Controlled Participants Previously Taking Oral or Infusion DMDs for RMS (MASTER-2)

Study Overview
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Brief Summary
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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.

Official Title
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Cladribine Tablets: Observational Evaluation of Effectiveness and PROs in Suboptimally Controlled Patients Previously Taking Oral or Infusion DMDs for RMS (MASTER-2)

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Cladribine Tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cladribine Tablets<br>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. | Drug: Cladribine Tablets<br>* No intervention will be administered as a part of this study. Participants will receive cladribine tablets as per investigator discretion and as per United States approved label: 3.5 milligram/kilogram (mg/kg) body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annualized Relapse Rate (ARR) (Prospective Assessment) | A relapse will be 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 up to 24 months of treatment with cladribine tablets, after baseline (prospectively collected data) will be reported. | Baseline (Month 0) up to 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Total 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) Total 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 6-Item Work Productivity Activity Impairment - Multiple Sclerosis (WPAI-MS) Total 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) |  | Baseline (Month 0) and at the end of Months 1, 2, 13 and 14 | 
| Percentage of Participants with Relapse (Prospective Assessment) | A relapse will be 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. Percentage of participants with relapse up to 24 months of treatment with cladribine tablets, after baseline (prospectively collected data) will be reported. | Month 12 and 24 | 
| Percentage of Participants With Relapse Associated With Hospitalization, Diagnosis or Reason for Hospitalization | A relapse will be 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. Percentage of participants with relapse associated with hospitalization, diagnosis or reason for hospitalization will be reported. | Month 12 and 24 | 
| Percentage of Participants With Relapse Associated With Glucocorticoid Use | A relapse will be 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. Percentage of participants with relapse associated with glucocorticoid use up to 24 months of treatment with cladribine tablets, after baseline (prospectively collected data) will be reported. | Month 12 and 24 | 
| Treatment Pattern as Evaluated by Number of Participants With Previous Treatment for Multiple Sclerosis (MS) |  | At Baseline (Month 0) | 
| Percentage of Participants Who Discontinue Cladribine Tablets |  | Baseline (Month 0) up to 24 Months | 
| Percentage 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 | 
| Percentage of Planned Doses Received by Participants as per United States Prescribing Information |  | Baseline (Month 0) up to 24 Months | 
| Number of Participants with Subsequent Treatment Chosen Following Discontinuation of Cladribine Tablets |  | Baseline (Month 0) up to 24 Months | 
| Number of Participants Assessed of Concomitant Multiple Sclerosis Medications Used During Study Period |  | Baseline (Month 0) up to 24 Months | 
| Annualized Relapse Rate (ARR) (Retrospective Assessment) | A relapse will 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 up to 24 months prior to baseline (retrospectively collected data) will be reported. | Up to 24 Months prior Baseline (Month 0) | 
| Number of Participants With Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Adverse Events of Special Interest (AESIs) and Special Situations | A serious adverse event (SAE) is an adverse event (AE) that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or is otherwise considered medically important. An ADR is a response to a medicinal product which is noxious and unintended. An AESI is an AE of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor can be appropriate. | Baseline (Month 0) up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Cladribine Tablets, Observational, Mavenclad