Cladribine Tablets: Observational Evaluation of Effectiveness and PROs in Suboptimally Controlled Patients Previously Taking Oral or Infusion DMDs for RMS (MASTER-2)
Status: Active_not_recruiting
Location: See all (50) locations...
Intervention Type: Drug
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
North Central Neurology Associates, P.C.
Cullman
University of South Alabama
Mobile
Arkansas
University of Arkansas for Medical Sciences
Little Rock
California
Fullerton Neurology and Headache Center
Fullerton
Regina Berkovich MD PhD INC
West Hollywood
Colorado
Colorado Springs Neurological Associates, PC - Neurology
Colorado Springs
Advanced Neurosciences Research, LLC
Fort Collins
Connecticut
Associated Neurologists of Southern Connecticut, PC
Fairfield
Florida
Neurology Associates, P. A.
Maitland
Orlando Health Multiple Sclerosis Comprehensive Care Center - Downtown Orlando
Orlando
Axiom Clinical Research of Florida
Tampa
University of South Florida
Tampa
Illinois
Northwest Neurology Ltd
Rolling Meadows
Prairie Education & Research
Springfield
Indiana
Fort Wayne Neurological Center
Fort Wayne
Kansas
College Park Family Care Center
Overland Park
Massachusetts
Neurological Clinical Research Institute
Boston
Neuro Institute of New England P.C.
Foxboro
The Elliot Lewis Center for Multiple Sclerosis Care
Wellesley
UMASS - Neurology
Worcester
Maine
Northern Light Comprehensive Multiple Sclerosis Care Center
Bangor
Michigan
Wayne State University (WSU) - Multiple Sclerosis Treatment and Clinical Research Center (MS Center) - Department of Neurology
Detroit
Detroit Clinical Research Center, PC
Farmington Hills
Memorial Healthcare
Owosso
Minnesota
Minneapolis Clinic of Neurology - Neurology
Golden Valley
North Carolina
Guilford Neurologic Associates
Greensboro
Raleigh Neurology Associates
Raleigh
Nevada
Neurology Center of Las Vegas
Las Vegas
New York
DENT Neurologic Institute
Amherst
The Trustee of Columbia University in the City of New York
New York
Ohio
Insight Neuroscience LLC
Bellevue
Dayton Center for Neurological Disorders
Dayton
Oregon
Providence Neurological Specialties
Portland
South Carolina
Premier Neurology Research, P.C.
Greer
Tennessee
Vanderbilt University Medical Center
Nashville
Texas
DHR Health Neurology Institute Neuroimmunology and Multiple Sclerosis
Mcallen
Central Texas Neurology Consultants
Round Rock
Neurology Center of San Antonio
San Antonio
Virginia
Integrated Neurology Services - Dr. Simon Fishman's Office
Alexandria
Blacksburg Neurology, PC
Christiansburg
Meridian Clinical Research (Neurology)
Norfolk
Neurological Associates
Richmond
Multiple Sclerosis Center of Greater Washington
Vienna
Sentara Ambulatory Care Center
Virginia Beach
Washington
MS Center of Evergreen
Kirkland
MultiCare Health System Institute for Research and Innovation - MultiCare Health System Institute for Research and
Spokane
MultiCare Health System Institute for Research and Innovation - MultiCare Health System Institute for Research
Tacoma
Wisconsin
Ascension St. Francis Center for Neurological Disorders, S.C.
Milwaukee
The Medical College of Wisconsin - Endocrinology
Milwaukee
Neuroscience Group of Northeast Wisconsin - DUPLICATE
Neenah
Time Frame
Start Date: 2019-07-22
Completion Date: 2025-05-12
Participants
Target number of participants: 295
Treatments
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.
Authors
Idanis Berrios Morales, Shanker N Dixit, Jill Cramer, Nada G Abou-Fayssal, Jeffrey L Gross, Robert C Sergott, Aaron Boster, Richard Sater, Rebecca Farber, James M Winkley, Kenneth A Mankowski, Brendan W Bauer, John Scagnelli, Susan Hibbs, Ajay S Gupta, Bhupendra O Khatri, Aparna Komatineni, Reuben M Valenzuela, Allen DeSena, Derrick S Robertson, Neeta Garg, Michelle Bowman, Theodore R Brown, Wisam Elmalik, Francesca R Bagnato, George J Hutton, Talal Derani, Andrew Bouley, Simon Fishman, Yashma Patel, Edward J Fox, Jeffrey Kaplan, Robert J Pace, Mary Hughes, Joshua Katz, Kyle E Smoot, Heidi Crayton, George Katsamakis, Alan E Schulman, Regina Berkovich, Salvatore Napoli, Mark C Cascione, Farrah Mateen, Jack H Florin, Ann D Bass, William D Honeycutt, Christopher C Laganke, Augusto A Miravalle, Warren L Felton
Related Therapeutic Areas
Sponsors
Collaborators: Merck KGaA, Darmstadt, Germany
Leads: EMD Serono Research & Development Institute, Inc.