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

NCT03933202

CompletedN/A

Sponsor: EMD Serono Research & Development Institute, Inc.

Conditions: Multiple Sclerosis

Interventions: Cladribine Tablets

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

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
Locations (66)
  • Cullman, Alabama, United States
  • Mobile, Alabama, United States
  • Little Rock, Arkansas, United States
  • Fullerton, California, United States
  • West Hollywood, California, United States
  • Colorado Springs, Colorado, United States
  • Englewood, Colorado, United States
  • Fort Collins, Colorado, United States
  • Fairfield, Connecticut, United States
  • Fairfield, Connecticut, United States
  • Maitland, Florida, United States
  • Miami, Florida, United States
  • Orlando, Florida, United States
  • St. Petersburg, Florida, United States
  • Tampa, Florida, United States
  • Tampa, Florida, United States
  • Rolling Meadows, Illinois, United States
  • Springfield, Illinois, United States
  • Fort Wayne, Indiana, United States
  • Overland Park, Kansas, United States
  • Lexington, Kentucky, United States
  • Bangor, Maine, United States
  • Boston, Massachusetts, United States
  • Foxborough, Massachusetts, United States
  • Wellesley, Massachusetts, United States
  • Worcester, Massachusetts, United States
  • Detroit, Michigan, United States
  • Farmington Hills, Michigan, United States
  • Owosso, Michigan, United States
  • Golden Valley, Minnesota, United States
  • + 36 more on CT.gov