A Study of Suboptimally Controlled Participants Previously Taking Oral or Infusion DMDs for RMS (MASTER-2)
NCT ID: NCT03933202
Last Updated: 2026-01-02
Study Results
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View full resultsBasic Information
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COMPLETED
291 participants
OBSERVATIONAL
2019-07-22
2024-11-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cladribine Tablets
No intervention will be administered as a part of this study. Participants who had decided prior to enrollment to transition from any oral or infusion DMD to treatment with cladribine tablets under routine clinical care and who meet all eligibility criteria will receive an initial treatment course with cladribine tablets in Year 1 and are planned to receive a second course in Year 2, as per the approved United States Prescribing Information (USPI). Data sources for this study will include data extracts from participants' medical records performed by site personnel as well as questionnaires directly filled out by participants.
Cladribine Tablets
No intervention will be administered as a part of this study. Participants will receive cladribine tablets as per investigator discretion and as per United States approved label: 3.5 milligram/kilogram (mg/kg) body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year.
Interventions
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Cladribine Tablets
No intervention will be administered as a part of this study. Participants will receive cladribine tablets as per investigator discretion and as per United States approved label: 3.5 milligram/kilogram (mg/kg) body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
EMD Serono Research & Development Institute, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
EMD Serono Inc., the biopharmaceutical division of Merck KGaA, Darmstadt, Germany
Locations
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North Central Neurology Associates, P.C.
Cullman, Alabama, United States
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
UMASS - Neurology
Worcester, Massachusetts, United States
Wayne State University (WSU) - Multiple Sclerosis Treatment and Clinical Research Center (MS Center) - Department of Neurology
Detroit, Michigan, United States
Detroit Clinical Research Center, PC
Farmington Hills, Michigan, United States
Memorial Healthcare
Owosso, Michigan, United States
Minneapolis Clinic of Neurology - Neurology
Golden Valley, Minnesota, United States
Neurology Center of Las Vegas
Las Vegas, Nevada, United States
DENT Neurologic Institute
Amherst, New York, United States
NYU Langone Brooklyn - Brooklyn
Brooklyn, New York, United States
The Trustee of Columbia University in the City of New York
New York, New York, United States
The Charlotte-Mecklenburg Hospital Authority - Carolinas Healthcare System
Charlotte, North Carolina, United States
Guilford Neurologic Associates
Greensboro, North Carolina, United States
Raleigh Neurology Associates
Raleigh, North Carolina, United States
Insight Neuroscience LLC
Bellevue, Ohio, United States
Riverhills Neuroscience
Cincinnati, Ohio, United States
The Boster Center for Multiple Scelosis
Columbus, Ohio, United States
Dayton Center for Neurological Disorders
Dayton, Ohio, United States
University of Toledo - PARENT
Toledo, Ohio, United States
Providence Neurological Specialties
Portland, Oregon, United States
Wills Eye Institute - Ocular Oncology Service - Wills Eye Institute
Philadelphia, Pennsylvania, United States
Premier Neurology Research, P.C.
Greer, South Carolina, United States
Neurology, PC
Knoxville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Northwest Houston Neurology
Cypress, Texas, United States
Baylor College of Medicine IRB
Houston, Texas, United States
DHR Health Neurology Institute Neuroimmunology and Multiple Sclerosis
McAllen, Texas, United States
Central Texas Neurology Consultants
Round Rock, Texas, United States
Neurology Center of San Antonio
San Antonio, Texas, United States
Integrated Neurology Services - Dr. Simon Fishman's Office
Alexandria, Virginia, United States
Blacksburg Neurology, PC
Christiansburg, Virginia, United States
Meridian Clinical Research (Neurology)
Norfolk, Virginia, United States
Neurological Associates
Richmond, Virginia, United States
VCU Medical Center - Pediatric Neurology
Richmond, Virginia, United States
Massey Cancer Center - VCU Medical Center
Richmond, Virginia, United States
Multiple Sclerosis Center of Greater Washington
Vienna, Virginia, United States
Sentara Ambulatory Care Center
Virginia Beach, Virginia, United States
MS Center of Evergreen
Kirkland, Washington, United States
MultiCare Health System Institute for Research and Innovation - MultiCare Health System Institute for Research and
Spokane, Washington, United States
MultiCare Health System Institute for Research and Innovation - MultiCare Health System Institute for Research
Tacoma, Washington, United States
Ascension St. Francis Center for Neurological Disorders, S.C.
Milwaukee, Wisconsin, United States
The Medical College of Wisconsin - Endocrinology
Milwaukee, Wisconsin, United States
Neuroscience Group of Northeast Wisconsin - DUPLICATE
Neenah, Wisconsin, United States
Countries
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References
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Miravalle AA, Katz J, Robertson D, Hayward B, Harlow DE, Lebson LA, Sloane JA, Bass AD, Fox EJ. CLICK-MS and MASTER-2 Phase IV trial design: cladribine tablets in suboptimally controlled relapsing multiple sclerosis. Neurodegener Dis Manag. 2021 Apr;11(2):99-111. doi: 10.2217/nmt-2020-0059. Epub 2021 Feb 1.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Trial Awareness and Transparency website
US Medical Information website, Medical Resources
Other Identifiers
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MS700568_0079
Identifier Type: -
Identifier Source: org_study_id
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