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.
- Diseases
- Multiple sclerosis
- 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
Sites (66)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Integrated Neurology Services - Dr. Simon Fishman's Office Coordinator of this site? Confirm its status | Alexandria | United States | Unknown status |
| Dent Neurologic Institute Coordinator of this site? Confirm its status | Amherst | United States | Unknown status |
| Northern Light Comprehensive Multiple Sclerosis Care Center Coordinator of this site? Confirm its status | Bangor | United States | Unknown status |
| Insight Neuroscience LLC Coordinator of this site? Confirm its status | Bellevue | United States | Unknown status |
| Neurological Clinical Research Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| NYU Langone Brooklyn - Brooklyn Coordinator of this site? Confirm its status | Brooklyn | United States | Unknown status |
| The Charlotte-Mecklenburg Hospital Authority - Carolinas Healthcare System Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Blacksburg Neurology, PC Coordinator of this site? Confirm its status | Christiansburg | United States | Unknown status |
| Riverhills Neuroscience Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Colorado Springs Neurological Associates, PC - Neurology Coordinator of this site? Confirm its status | Colorado Springs | United States | Unknown status |
| The Boster Center for Multiple Scelosis Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| North Central Neurology Associates, P.C. Coordinator of this site? Confirm its status | Cullman | United States | Unknown status |
| Northwest Houston Neurology Coordinator of this site? Confirm its status | Cypress | United States | Unknown status |
| Dayton Center for Neurological Disorders Coordinator of this site? Confirm its status | Dayton | United States | Unknown status |
| Wayne State University (WSU) - Multiple Sclerosis Treatment and Clinical Research Center (MS Center) - Department of Neurology Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| HCA Research Institute Coordinator of this site? Confirm its status | Englewood | United States | Unknown status |
| Yale University Coordinator of this site? Confirm its status | Fairfield | United States | Unknown status |
| Associated Neurologists of Southern Connecticut, PC Coordinator of this site? Confirm its status | Fairfield | United States | Unknown status |
| Detroit Clinical Research Center, PC Coordinator of this site? Confirm its status | Farmington Hills | United States | Unknown status |
| Advanced Neurosciences Research, Llc Coordinator of this site? Confirm its status | Fort Collins | United States | Unknown status |
| Fort Wayne Neurological Center Coordinator of this site? Confirm its status | Fort Wayne | United States | Unknown status |
| Neuro Institute of New England P C Coordinator of this site? Confirm its status | Foxborough | United States | Unknown status |
| Fullerton Neurology and Headache Center Coordinator of this site? Confirm its status | Fullerton | United States | Unknown status |
| Minneapolis Clinic of Neurology - Neurology Coordinator of this site? Confirm its status | Golden Valley | United States | Unknown status |
| Guilford Neurologic Associates Coordinator of this site? Confirm its status | Greensboro | United States | Unknown status |
| Premier Neurology Research, P.C. Coordinator of this site? Confirm its status | Greer | United States | Unknown status |
| Baylor College of Medicine IRB Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| MS Center of Evergreen Coordinator of this site? Confirm its status | Kirkland | United States | Unknown status |
| Neurology, PC Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
| Neurology Center of Las Vegas Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Baptist Health Lexington Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| University of Arkansas for Medical Sciences Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| Neurology Associates, P. A. Coordinator of this site? Confirm its status | Maitland | United States | Unknown status |
| DHR Health Neurology Institute Neuroimmunology and Multiple Sclerosis Coordinator of this site? Confirm its status | McAllen | United States | Unknown status |
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Ascension St. Francis Center for Neurological Disorders, S.C. Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| The Medical College of Wisconsin - Endocrinology Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| University of South Alabama Coordinator of this site? Confirm its status | Mobile | United States | Unknown status |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Neuroscience Group of Northeast Wisconsin - DUPLICATE Coordinator of this site? Confirm its status | Neenah | United States | Unknown status |
| The Trustee of Columbia University in the City of New York Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Meridian Clinical Research (Neurology) Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| Orlando Health Multiple Sclerosis Comprehensive Care Center - Downtown Orlando Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| College Park Family Care Center Coordinator of this site? Confirm its status | Overland Park | United States | Unknown status |
| Memorial Healthcare Coordinator of this site? Confirm its status | Owosso | United States | Unknown status |
| Wills Eye Institute - Ocular Oncology Service - Wills Eye Institute Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Providence Neurological Specialties Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Raleigh Neurology Associates Coordinator of this site? Confirm its status | Raleigh | United States | Unknown status |
| Neurological Associates Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| VCU Medical Center - Pediatric Neurology Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Massey Cancer Center - VCU Medical Center Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Northwest Neurology Ltd Coordinator of this site? Confirm its status | Rolling Meadows | United States | Unknown status |
| Central Texas Neurology Consultants Coordinator of this site? Confirm its status | Round Rock | United States | Unknown status |
| Neurology Center of San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| MultiCare Health System Institute for Research and Innovation - MultiCare Health System Institute for Research and Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
| Prairie Education & Research Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Suncoast Neuroscience and Associates, Inc. Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
| MultiCare Health System Institute for Research and Innovation - MultiCare Health System Institute for Research Coordinator of this site? Confirm its status | Tacoma | United States | Unknown status |
| University of South Florida Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Axiom Clinical Research of Florida Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| University of Toledo - PARENT Coordinator of this site? Confirm its status | Toledo | United States | Unknown status |
| Multiple Sclerosis Center of Greater Washington Coordinator of this site? Confirm its status | Vienna | United States | Unknown status |
| Sentara Ambulatory Care Center Coordinator of this site? Confirm its status | Virginia Beach | United States | Unknown status |
| The Elliot Lewis Center for Multiple Sclerosis Care Coordinator of this site? Confirm its status | Wellesley | United States | Unknown status |
| Regina Berkovich MD PhD Inc Coordinator of this site? Confirm its status | West Hollywood | United States | Unknown status |
| UMASS - Neurology Coordinator of this site? Confirm its status | Worcester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.