A Study of Suboptimally Controlled Participants Previously Taking Oral or Infusion DMDs for RMS (MASTER-2)
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
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
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Multiple Sclerosis
Age (in years)
18+
Participants needed
295
Est. Completion Date
Nov 15, 2026
Treatment type
Observational
Sponsor
EMD Serono
ClinicalTrials.gov identifier
NCT03933202
Study number
MS700568_0079
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