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

NCT03933202 | Completed Results

• 1 other identifier: MS700568_0079
• Study Type: observational
• Target: 291
• Locations: 1 country
• Sites: 66

Brief 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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Cladribine Tablets; Observational; Mavenclad

Outcome Measures

Primary Outcomes (1)

• Annualized Relapse Rate (ARR)

  A relapse was defined as per routine clinical practice as determined by the investigator. As a guide, relapse may be defined as exacerbation of symptoms that occur over a minimum of 24 hours and separated from a previous attack by at least 30 days, in the absence of fever or infection. ARR was calculated as the total number of reported relapses in the 24 months after treatment divided by the days on study corresponding to relapse information and multiplied by 365.25.

  From first dose of cladribine tablets up to 24 months

Secondary Outcomes (25)

• Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24

  Baseline (Month 0), Month 6, 12 and 24

• Change From Baseline in 36-Item Short Form Health Survey (SF-36) Domain Score at Month 6, 12 and 24

  Baseline (Month 0), Month 6, 12 and 24

• Change From Baseline in Modified Fatigue Impact Scale - 5-item Version (MFIS-5) Total Score at Month 6, 12 and 24

  Baseline (Month 0), Month 6, 12 and 24

• Change From Baseline in 7-Item Beck-Depression Inventory-Fast Screen (BDI-FS) Total Score at Month 6, 12 and 24

  Baseline (Month 0), Month 6, 12 and 24

• Change From Baseline in Percentage of Work Time Missed Assessed by 6-Item Work Productivity Activity Impairment - Multiple Sclerosis (WPAI-MS) Score at Month 6, 12 and 24

  Baseline (Month 0), Month 6, 12 and 24

Study Arms (1)

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.

Drug: Cladribine Tablets

Interventions

Cladribine Tablets DRUG

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.

Cladribine Tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with relapsing form of Multiple Sclerosis (RMS) including active secondary progressive multiple sclerosis (aSPMS).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EMD Serono Research & Development Institute, Inc.: lead
• Merck KGaA, Darmstadt, Germany: collaborator

Study Sites (66)

North Central Neurology Associates, P.C.

Cullman, Alabama, 35058, United States

Location

University of South Alabama

Mobile, Alabama, 36693, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Fullerton Neurology and Headache Center

Fullerton, California, 92835, United States

Location

Regina Berkovich MD PhD INC

West Hollywood, California, 90048, United States

Location

Colorado Springs Neurological Associates, PC - Neurology

Colorado Springs, Colorado, 80907, United States

Location

HCA Research Institute

Englewood, Colorado, 80113, United States

Location

Advanced Neurosciences Research, LLC

Fort Collins, Colorado, 80528, United States

Location

Associated Neurologists of Southern Connecticut, PC

Fairfield, Connecticut, 06824, United States

Location

Yale University

Fairfield, Connecticut, 06824, United States

Location

Neurology Associates, P. A.

Maitland, Florida, 32751, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Orlando Health Multiple Sclerosis Comprehensive Care Center - Downtown Orlando

Orlando, Florida, 32806, United States

Location

Suncoast Neuroscience and Associates, Inc.

St. Petersburg, Florida, 33713, United States

Location

Axiom Clinical Research of Florida

Tampa, Florida, 33609, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

Northwest Neurology Ltd

Rolling Meadows, Illinois, 60008, United States

Location

Prairie Education & Research

Springfield, Illinois, 62702, United States

Location

Fort Wayne Neurological Center

Fort Wayne, Indiana, 46804, United States

Location

College Park Family Care Center

Overland Park, Kansas, 66212, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

Northern Light Comprehensive Multiple Sclerosis Care Center

Bangor, Maine, 04401, United States

Location

Neurological Clinical Research Institute

Boston, Massachusetts, 02114, United States

Location

Neuro Institute of New England P.C.

Foxborough, Massachusetts, 02035, United States

Location

The Elliot Lewis Center for Multiple Sclerosis Care

Wellesley, Massachusetts, 02481, United States

Location

UMASS - Neurology

Worcester, Massachusetts, 01655, United States

Location

Wayne State University (WSU) - Multiple Sclerosis Treatment and Clinical Research Center (MS Center) - Department of Neurology

Detroit, Michigan, 48201, United States

Location

Detroit Clinical Research Center, PC

Farmington Hills, Michigan, 48334, United States

Location

Memorial Healthcare

Owosso, Michigan, 48867, United States

Location

Minneapolis Clinic of Neurology - Neurology

Golden Valley, Minnesota, 55422, United States

Location

Neurology Center of Las Vegas

Las Vegas, Nevada, 89128, United States

Location

DENT Neurologic Institute

Amherst, New York, 14226, United States

Location

NYU Langone Brooklyn - Brooklyn

Brooklyn, New York, 11220, United States

Location

The Trustee of Columbia University in the City of New York

New York, New York, 10032, United States

Location

The Charlotte-Mecklenburg Hospital Authority - Carolinas Healthcare System

Charlotte, North Carolina, 28203, United States

Location

Guilford Neurologic Associates

Greensboro, North Carolina, 27405, United States

Location

Raleigh Neurology Associates

Raleigh, North Carolina, 27607-6010, United States

Location

Insight Neuroscience LLC

Bellevue, Ohio, 44811, United States

Location

Riverhills Neuroscience

Cincinnati, Ohio, 45212, United States

Location

The Boster Center for Multiple Scelosis

Columbus, Ohio, 43235, United States

Location

Dayton Center for Neurological Disorders

Dayton, Ohio, 45459, United States

Location

University of Toledo - PARENT

Toledo, Ohio, 43614-2598, United States

Location

Providence Neurological Specialties

Portland, Oregon, 97225, United States

Location

Wills Eye Institute - Ocular Oncology Service - Wills Eye Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Premier Neurology Research, P.C.

Greer, South Carolina, 29650, United States

Location

Neurology, PC

Knoxville, Tennessee, 37922, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Northwest Houston Neurology

Cypress, Texas, 77429, United States

Location

Baylor College of Medicine IRB

Houston, Texas, 77030, United States

Location

DHR Health Neurology Institute Neuroimmunology and Multiple Sclerosis

McAllen, Texas, 78503, United States

Location

Central Texas Neurology Consultants

Round Rock, Texas, 78681, United States

Location

Neurology Center of San Antonio

San Antonio, Texas, 78258, United States

Location

Integrated Neurology Services - Dr. Simon Fishman's Office

Alexandria, Virginia, 22310, United States

Location

Blacksburg Neurology, PC

Christiansburg, Virginia, 24073, United States

Location

Meridian Clinical Research (Neurology)

Norfolk, Virginia, 23502, United States

Location

Neurological Associates

Richmond, Virginia, 23226, United States

Location

VCU Medical Center - Pediatric Neurology

Richmond, Virginia, 23298-0211, United States

Location

Massey Cancer Center - VCU Medical Center

Richmond, Virginia, 23298, United States

Location

Multiple Sclerosis Center of Greater Washington

Vienna, Virginia, 22182, United States

Location

Sentara Ambulatory Care Center

Virginia Beach, Virginia, 23456, United States

Location

MS Center of Evergreen

Kirkland, Washington, 98034, United States

Location

MultiCare Health System Institute for Research and Innovation - MultiCare Health System Institute for Research and

Spokane, Washington, 99202, United States

Location

MultiCare Health System Institute for Research and Innovation - MultiCare Health System Institute for Research

Tacoma, Washington, 98405, United States

Location

Ascension St. Francis Center for Neurological Disorders, S.C.

Milwaukee, Wisconsin, 53215, United States

Location

The Medical College of Wisconsin - Endocrinology

Milwaukee, Wisconsin, 53226, United States

Location

Neuroscience Group of Northeast Wisconsin - DUPLICATE

Neenah, Wisconsin, 54956, United States

Location

Related Publications (1)

• 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.

  PMID: 33517769 DERIVED

Related Links

• Trial Awareness and Transparency website
• US Medical Information website, Medical Resources

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Cladribine

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

2-Chloroadenosine; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxyadenosines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Results Point of Contact

• Title: Communication Center
• Organization: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA,Darmstadt, Germany

service@emdgroup.com

6151725200

Study Officials

• Medical Responsible

  EMD Serono Inc., the biopharmaceutical division of Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 1, 2019
• Study Start: July 22, 2019
• Primary Completion: November 11, 2024
• Study Completion: November 11, 2024
• Last Updated: January 2, 2026
• Results First Posted: January 2, 2026

Record last verified: 2025-12

Locations

US (66)