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Cladribine Tablets: Observational Evaluation of Effectiveness and Patient-Reported Outcomes (PROs) in Suboptimally Controlled Patients Previously Taking Oral or Infusion Disease-Modifying Drugs (DMDs) for Relapsing Forms of Multiple Sclerosis (RMS) (MASTER-2)


Brief Summary:

To evaluate the effectiveness and safety 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 DMD approved in the United States (US) for RMS in a real-world-setting.


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 3 months

– Have decided to initiate treatment with cladribine tablets during routine clinical

– 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

– 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


  • Fullerton Neurology and Headache Center, Fullerton, California, United States, 92835
  • Regina Berkovich MD PhD INC, West Hollywood, California, United States, 90048
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