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

Completed

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT03933202

Run by

EMD Serono Research & Development Institute, Inc.

People needed

291

Starts

2019-07-22

Expected to finish

2024-11-11

Last updated by the study team

2026-01-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of South Alabama — Mobile, Alabama, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Fullerton Neurology and Headache Center — Fullerton, California, United States
• Regina Berkovich MD PhD INC — West Hollywood, California, United States
• Colorado Springs Neurological Associates, PC - Neurology — Colorado Springs, Colorado, United States
• HCA Research Institute — Englewood, Colorado, United States
• Advanced Neurosciences Research, LLC — Fort Collins, Colorado, United States
• Associated Neurologists of Southern Connecticut, PC — Fairfield, Connecticut, United States
• Yale University — Fairfield, Connecticut, United States
• Neurology Associates, P. A. — Maitland, Florida, United States
• University of Miami — Miami, Florida, United States
• Orlando Health Multiple Sclerosis Comprehensive Care Center - Downtown Orlando — Orlando, Florida, United States
• Suncoast Neuroscience and Associates, Inc. — St. Petersburg, Florida, United States
• Axiom Clinical Research of Florida — Tampa, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Northwest Neurology Ltd — Rolling Meadows, Illinois, United States
• Prairie Education & Research — Springfield, Illinois, United States
• Fort Wayne Neurological Center — Fort Wayne, Indiana, United States
• College Park Family Care Center — Overland Park, Kansas, United States
• Baptist Health Lexington — Lexington, Kentucky, United States
• Northern Light Comprehensive Multiple Sclerosis Care Center — Bangor, Maine, United States
• Neurological Clinical Research Institute — Boston, Massachusetts, United States
• Neuro Institute of New England P.C. — Foxborough, Massachusetts, United States
• The Elliot Lewis Center for Multiple Sclerosis Care — Wellesley, Massachusetts, United States
• North Central Neurology Associates, P.C. — Cullman, Alabama, United States

Full record on ClinicalTrials.gov

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