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

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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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. Signed informed consent
  2. Have diagnosis of RMS, including RRMS and aSPMS, and satisfy the approved indication for cladribine tablets as per United States Prescribing Information (USPI)
  3. Have time since diagnosis of RMS of at least 12 months
  4. 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
  5. Had received their last previous oral DMD for at least 1 month or at least 1 dose of their last previous infusion DMD
  6. Have decided to initiate treatment with cladribine tablets during routine clinical care
  7. Meet criteria as per the approved USPI
  8. Have access to a valid e-mail address

EXCLUSION CRITERIA

Exclusion Criteria:


  1. Have been previously treated with cladribine in any dosing form (intravenous, subcutaneous, or oral)
  2. Transitioning from previous oral DMD solely for administrative reasons such as relocation
  3. Have comorbid conditions that preclude participation
  4. Have any clinical condition or medical history noted as contraindication on USPI
  5. Are currently participating in an interventional clinical trial
  6. Pregnant or breastfeeding women, women who plan to become pregnant or men whose partner plans to become pregnant during study the cladribine treatment period

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

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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