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.

View Eligibility Criteria

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

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

295

Study ID:

NCT03933202

Recruitment Status:

Active, not recruiting

Sponsor:

EMD Serono Research & Development Institute, Inc.

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There are 50 Locations for this study

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North Central Neurology Associates, P.C.
Cullman Alabama, 35058, United States
University of South Alabama
Mobile Alabama, 36693, United States
University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
Fullerton Neurology and Headache Center
Fullerton California, 92835, United States
Regina Berkovich MD PhD INC
West Hollywood California, 90048, United States
Colorado Springs Neurological Associates, PC - Neurology
Colorado Springs Colorado, 80907, United States
Advanced Neurosciences Research, LLC
Fort Collins Colorado, 80528, United States
Associated Neurologists of Southern Connecticut, PC
Fairfield Connecticut, 06824, United States
Neurology Associates, P. A.
Maitland Florida, 32751, United States
Orlando Health Multiple Sclerosis Comprehensive Care Center - Downtown Orlando
Orlando Florida, 32806, United States
Axiom Clinical Research of Florida
Tampa Florida, 33609, United States
University of South Florida
Tampa Florida, 33612, United States
Northwest Neurology Ltd
Rolling Meadows Illinois, 60008, United States
Prairie Education & Research
Springfield Illinois, 62702, United States
Fort Wayne Neurological Center
Fort Wayne Indiana, 46804, United States
College Park Family Care Center
Overland Park Kansas, 66212, United States
Northern Light Comprehensive Multiple Sclerosis Care Center
Bangor Maine, 04401, United States
Neurological Clinical Research Institute
Boston Massachusetts, 02114, United States
Neuro Institute of New England P.C.
Foxboro Massachusetts, 02035, United States
The Elliot Lewis Center for Multiple Sclerosis Care
Wellesley Massachusetts, 02481, United States
UMASS - Neurology
Worcester Massachusetts, 01655, United States
Wayne State University (WSU) - Multiple Sclerosis Treatment and Clinical Research Center (MS Center) - Department of Neurology
Detroit Michigan, 48201, United States
Detroit Clinical Research Center, PC
Farmington Hills Michigan, 48334, United States
Memorial Healthcare
Owosso Michigan, 48867, United States
Minneapolis Clinic of Neurology - Neurology
Golden Valley Minnesota, 55422, United States
Neurology Center of Las Vegas
Las Vegas Nevada, 89128, United States
DENT Neurologic Institute
Amherst New York, 14226, United States
The Trustee of Columbia University in the City of New York
New York New York, 10032, United States
Guilford Neurologic Associates
Greensboro North Carolina, 27405, United States
Raleigh Neurology Associates
Raleigh North Carolina, 27607, United States
Insight Neuroscience LLC
Bellevue Ohio, 44811, United States
Dayton Center for Neurological Disorders
Dayton Ohio, 45459, United States
Providence Neurological Specialties
Portland Oregon, 97225, United States
Premier Neurology Research, P.C.
Greer South Carolina, 29650, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
DHR Health Neurology Institute Neuroimmunology and Multiple Sclerosis
McAllen Texas, 78503, United States
Central Texas Neurology Consultants
Round Rock Texas, 78681, United States
Neurology Center of San Antonio
San Antonio Texas, 78258, United States
Integrated Neurology Services - Dr. Simon Fishman's Office
Alexandria Virginia, 22310, United States
Blacksburg Neurology, PC
Christiansburg Virginia, 24073, United States
Meridian Clinical Research (Neurology)
Norfolk Virginia, 23502, United States
Neurological Associates
Richmond Virginia, 23226, United States
Multiple Sclerosis Center of Greater Washington
Vienna Virginia, 22182, United States
Sentara Ambulatory Care Center
Virginia Beach Virginia, 23456, United States
MS Center of Evergreen
Kirkland Washington, 98034, United States
MultiCare Health System Institute for Research and Innovation - MultiCare Health System Institute for Research and
Spokane Washington, 99202, United States
MultiCare Health System Institute for Research and Innovation - MultiCare Health System Institute for Research
Tacoma Washington, 98405, United States
Ascension St. Francis Center for Neurological Disorders, S.C.
Milwaukee Wisconsin, 53215, United States
The Medical College of Wisconsin - Endocrinology
Milwaukee Wisconsin, 53226, United States
Neuroscience Group of Northeast Wisconsin - DUPLICATE
Neenah Wisconsin, 54956, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

295

Study ID:

NCT03933202

Recruitment Status:

Active, not recruiting

Sponsor:


EMD Serono Research & Development Institute, Inc.

How clear is this clinincal trial information?

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