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

  • End date
    Nov 15, 2026
  • participants needed
  • sponsor
    EMD Serono Research & Development Institute, Inc.
Updated on 25 October 2021
US Medical Information
Primary Contact
Northwest Neurology Ltd (4.2 mi away) Contact
+54 other location
disease or disorder
chronic progressive multiple sclerosis
relapsing multiple sclerosis
secondary progressive multiple sclerosis


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.

Condition Multiple Sclerosis, Radiologically Isolated Syndrome, Dermatite Atopique modérée ou grave, multiple sclerosis (ms)
Treatment Cladribine Tablets
Clinical Study IdentifierNCT03933202
SponsorEMD Serono Research & Development Institute, Inc.
Last Modified on25 October 2021


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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