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A Study of Suboptimally Controlled Participants Previously Taking Oral or Infusion DMDs for RMS (MASTER-2) | Clinical Trials | Clareo Health

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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)

NCT03933202•EMD Serono Research & Development Institute, Inc.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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

Locations (66)

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

Key Dates

Start Date

July 22, 2019

Primary Completion Date

November 11, 2024

Completion Date

November 11, 2024

Last Updated

January 2, 2026

Enrollment

291

ACTUAL participants

Conditions

Multiple Sclerosis

Interventions

Cladribine Tablets

DRUG

A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

NCT07225504

Secondary Progressive Multiple Sclerosis (SPMS)

View study

RECRUITINGNA

Intermittent Hypoxia in Persons With Multiple Sclerosis

NCT06276634

Multiple SclerosisMultiple Sclerosis-Relapsing-Remitting+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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