Multiple Sclerosis Clinical Trial
A Study of Suboptimally Controlled Participants Previously Taking Oral or Infusion DMDs for RMS (MASTER-2)
Summary
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.
Eligibility 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:
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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There are 50 Locations for this study
Cullman Alabama, 35058, United States
Mobile Alabama, 36693, United States
Little Rock Arkansas, 72205, United States
Fullerton California, 92835, United States
West Hollywood California, 90048, United States
Colorado Springs Colorado, 80907, United States
Fort Collins Colorado, 80528, United States
Fairfield Connecticut, 06824, United States
Maitland Florida, 32751, United States
Orlando Florida, 32806, United States
Tampa Florida, 33609, United States
Tampa Florida, 33612, United States
Rolling Meadows Illinois, 60008, United States
Springfield Illinois, 62702, United States
Fort Wayne Indiana, 46804, United States
Overland Park Kansas, 66212, United States
Bangor Maine, 04401, United States
Boston Massachusetts, 02114, United States
Foxboro Massachusetts, 02035, United States
Wellesley Massachusetts, 02481, United States
Worcester Massachusetts, 01655, United States
Detroit Michigan, 48201, United States
Farmington Hills Michigan, 48334, United States
Owosso Michigan, 48867, United States
Golden Valley Minnesota, 55422, United States
Las Vegas Nevada, 89128, United States
Amherst New York, 14226, United States
New York New York, 10032, United States
Greensboro North Carolina, 27405, United States
Raleigh North Carolina, 27607, United States
Bellevue Ohio, 44811, United States
Dayton Ohio, 45459, United States
Portland Oregon, 97225, United States
Greer South Carolina, 29650, United States
Nashville Tennessee, 37232, United States
McAllen Texas, 78503, United States
Round Rock Texas, 78681, United States
San Antonio Texas, 78258, United States
Alexandria Virginia, 22310, United States
Christiansburg Virginia, 24073, United States
Norfolk Virginia, 23502, United States
Richmond Virginia, 23226, United States
Vienna Virginia, 22182, United States
Virginia Beach Virginia, 23456, United States
Kirkland Washington, 98034, United States
Spokane Washington, 99202, United States
Tacoma Washington, 98405, United States
Milwaukee Wisconsin, 53215, United States
Milwaukee Wisconsin, 53226, United States
Neenah Wisconsin, 54956, United States
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