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NCT03933202Completed

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

Cladribine Tablets: Observational Evaluation of Effectiveness and PROs in Suboptimally Controlled Patients Previously Taking Oral or Infusion DMDs for RMS (MASTER-2)

Source: ClinicalTrials.gov · Last updated 2 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
291 (actual)
First submitted
29 Apr 2019
Start date
22 Jul 2019
Primary completion date
11 Nov 2024
Lead sponsor
EMD Serono Research & Development Institute, Inc.
NCT number
NCT03933202

What you commit to

  • Study type: Observational
  • Participants enrolled: 291
  • From 22 Jul 2019 to the primary completion date, 11 Nov 2024
  • 66 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • Have comorbid conditions that preclude participation
  • Have any clinical condition or medical history noted as contraindication on USPI

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (66)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Integrated Neurology Services - Dr. Simon Fishman's Office
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AlexandriaUnited StatesUnknown status
Dent Neurologic Institute
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AmherstUnited StatesUnknown status
Northern Light Comprehensive Multiple Sclerosis Care Center
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BangorUnited StatesUnknown status
Insight Neuroscience LLC
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BellevueUnited StatesUnknown status
Neurological Clinical Research Institute
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BostonUnited StatesUnknown status
NYU Langone Brooklyn - Brooklyn
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BrooklynUnited StatesUnknown status
The Charlotte-Mecklenburg Hospital Authority - Carolinas Healthcare System
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CharlotteUnited StatesUnknown status
Blacksburg Neurology, PC
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ChristiansburgUnited StatesUnknown status
Riverhills Neuroscience
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CincinnatiUnited StatesUnknown status
Colorado Springs Neurological Associates, PC - Neurology
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Colorado SpringsUnited StatesUnknown status
The Boster Center for Multiple Scelosis
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ColumbusUnited StatesUnknown status
North Central Neurology Associates, P.C.
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CullmanUnited StatesUnknown status
Northwest Houston Neurology
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CypressUnited StatesUnknown status
Dayton Center for Neurological Disorders
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DaytonUnited StatesUnknown status
Wayne State University (WSU) - Multiple Sclerosis Treatment and Clinical Research Center (MS Center) - Department of Neurology
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DetroitUnited StatesUnknown status
HCA Research Institute
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EnglewoodUnited StatesUnknown status
Yale University
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FairfieldUnited StatesUnknown status
Associated Neurologists of Southern Connecticut, PC
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FairfieldUnited StatesUnknown status
Detroit Clinical Research Center, PC
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Farmington HillsUnited StatesUnknown status
Advanced Neurosciences Research, Llc
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Fort CollinsUnited StatesUnknown status
Fort Wayne Neurological Center
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Fort WayneUnited StatesUnknown status
Neuro Institute of New England P C
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FoxboroughUnited StatesUnknown status
Fullerton Neurology and Headache Center
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FullertonUnited StatesUnknown status
Minneapolis Clinic of Neurology - Neurology
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Golden ValleyUnited StatesUnknown status
Guilford Neurologic Associates
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GreensboroUnited StatesUnknown status
Premier Neurology Research, P.C.
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GreerUnited StatesUnknown status
Baylor College of Medicine IRB
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HoustonUnited StatesUnknown status
MS Center of Evergreen
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KirklandUnited StatesUnknown status
Neurology, PC
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KnoxvilleUnited StatesUnknown status
Neurology Center of Las Vegas
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Las VegasUnited StatesUnknown status
Baptist Health Lexington
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LexingtonUnited StatesUnknown status
University of Arkansas for Medical Sciences
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Little RockUnited StatesUnknown status
Neurology Associates, P. A.
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MaitlandUnited StatesUnknown status
DHR Health Neurology Institute Neuroimmunology and Multiple Sclerosis
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McAllenUnited StatesUnknown status
University of Miami
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MiamiUnited StatesUnknown status
Ascension St. Francis Center for Neurological Disorders, S.C.
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MilwaukeeUnited StatesUnknown status
The Medical College of Wisconsin - Endocrinology
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MilwaukeeUnited StatesUnknown status
University of South Alabama
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MobileUnited StatesUnknown status
Vanderbilt University Medical Center
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NashvilleUnited StatesUnknown status
Neuroscience Group of Northeast Wisconsin - DUPLICATE
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NeenahUnited StatesUnknown status
The Trustee of Columbia University in the City of New York
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New YorkUnited StatesUnknown status
Meridian Clinical Research (Neurology)
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NorfolkUnited StatesUnknown status
Orlando Health Multiple Sclerosis Comprehensive Care Center - Downtown Orlando
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OrlandoUnited StatesUnknown status
College Park Family Care Center
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Overland ParkUnited StatesUnknown status
Memorial Healthcare
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OwossoUnited StatesUnknown status
Wills Eye Institute - Ocular Oncology Service - Wills Eye Institute
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PhiladelphiaUnited StatesUnknown status
Providence Neurological Specialties
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PortlandUnited StatesUnknown status
Raleigh Neurology Associates
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RaleighUnited StatesUnknown status
Neurological Associates
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RichmondUnited StatesUnknown status
VCU Medical Center - Pediatric Neurology
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RichmondUnited StatesUnknown status
Massey Cancer Center - VCU Medical Center
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RichmondUnited StatesUnknown status
Northwest Neurology Ltd
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Rolling MeadowsUnited StatesUnknown status
Central Texas Neurology Consultants
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Round RockUnited StatesUnknown status
Neurology Center of San Antonio
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San AntonioUnited StatesUnknown status
MultiCare Health System Institute for Research and Innovation - MultiCare Health System Institute for Research and
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SpokaneUnited StatesUnknown status
Prairie Education & Research
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SpringfieldUnited StatesUnknown status
Suncoast Neuroscience and Associates, Inc.
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St. PetersburgUnited StatesUnknown status
MultiCare Health System Institute for Research and Innovation - MultiCare Health System Institute for Research
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TacomaUnited StatesUnknown status
University of South Florida
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TampaUnited StatesUnknown status
Axiom Clinical Research of Florida
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TampaUnited StatesUnknown status
University of Toledo - PARENT
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ToledoUnited StatesUnknown status
Multiple Sclerosis Center of Greater Washington
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ViennaUnited StatesUnknown status
Sentara Ambulatory Care Center
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Virginia BeachUnited StatesUnknown status
The Elliot Lewis Center for Multiple Sclerosis Care
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WellesleyUnited StatesUnknown status
Regina Berkovich MD PhD Inc
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West HollywoodUnited StatesUnknown status
UMASS - Neurology
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WorcesterUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.