Clinical trial NCT03933202: A Study of Suboptimally Controlled Participants Previously Taking Oral or Infusion DMDs for RMS (MASTER-2)
Official title: Cladribine Tablets: Observational Evaluation of Effectiveness and PROs in Suboptimally Controlled Patients Previously Taking Oral or Infusion DMDs for RMS (MASTER-2)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Cladribine Tablets
Observational
Mavenclad
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
Collaborators: name: Merck KGaA, Darmstadt, Germany
First posted: 2019-05-01
Enrollment: 291
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with relapsing form of Multiple Sclerosis (RMS) including active secondary progressive multiple sclerosis (aSPMS).

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.


Eligibility criteria: 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

Primary outcomes:
measure: Annualized Relapse Rate (ARR) (Prospective Assessment)
timeFrame: Baseline (Month 0) up to 24 Months
Secondary outcomes:
measure: Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Total Score at Month 6, 12 and 24
timeFrame: Baseline (Month 0), Month 6, 12 and 24
measure: Change From Baseline in 36-Item Short Form Health Survey (SF-36) Total Score at Month 6, 12 and 24
timeFrame: Baseline (Month 0), Month 6, 12 and 24
measure: Change From Baseline in Modified Fatigue Impact Scale - 5-item version (MFIS-5) Total Score at Month 6, 12 and 24
timeFrame: Baseline (Month 0), Month 6, 12 and 24
measure: Change From Baseline in 7-Item Beck-Depression Inventory-Fast Screen (BDI-FS) Total Score at Month 6, 12 and 24
timeFrame: Baseline (Month 0), Month 6, 12 and 24
measure: Change From Baseline in 6-Item Work Productivity Activity Impairment - Multiple Sclerosis (WPAI-MS) Total Score at Month 6, 12 and 24
timeFrame: Baseline (Month 0), Month 6, 12 and 24
measure: Change From Baseline in Patient Determined Disease Steps (PDDS) Scale Total Score at Month 6, 12 and 24
timeFrame: Baseline (Month 0), Month 6, 12 and 24
measure: Number of Participants With Adherence to Treatment as Assessed by Modified Versions of the Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ)
timeFrame: Baseline (Month 0) and at the end of Months 1, 2, 13 and 14
measure: Percentage of Participants with Relapse (Prospective Assessment)
timeFrame: Month 12 and 24
measure: Percentage of Participants With Relapse Associated With Hospitalization, Diagnosis or Reason for Hospitalization
timeFrame: Month 12 and 24
measure: Percentage of Participants With Relapse Associated With Glucocorticoid Use
timeFrame: Month 12 and 24
measure: Treatment Pattern as Evaluated by Number of Participants With Previous Treatment for Multiple Sclerosis (MS)
timeFrame: At Baseline (Month 0)
measure: Percentage of Participants Who Discontinue Cladribine Tablets
timeFrame: Baseline (Month 0) up to 24 Months
measure: Percentage of Participants With Reason for Discontinuation of Cladribine Tablets
timeFrame: Baseline (Month 0) up to 24 Months
measure: Elapsed Time to Discontinuation After First Dose of Cladribine Tablets
timeFrame: Baseline (Month 0) up to 24 Months
measure: Number of Doses Received by Participants as per United States Prescribing Information
timeFrame: Baseline (Month 0) up to 24 Months
measure: Percentage of Planned Doses Received by Participants as per United States Prescribing Information
timeFrame: Baseline (Month 0) up to 24 Months
measure: Number of Participants with Subsequent Treatment Chosen Following Discontinuation of Cladribine Tablets
timeFrame: Baseline (Month 0) up to 24 Months
measure: Number of Participants Assessed of Concomitant Multiple Sclerosis Medications Used During Study Period
timeFrame: Baseline (Month 0) up to 24 Months
measure: Annualized Relapse Rate (ARR) (Retrospective Assessment)
timeFrame: Up to 24 Months prior Baseline (Month 0)
measure: Number of Participants With Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Adverse Events of Special Interest (AESIs) and Special Situations
timeFrame: Baseline (Month 0) up to 24 months
Other outcomes:
Locations:
city: Cullman
country: United States
facility: North Central Neurology Associates, P.C.
state: Alabama
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Fullerton
country: United States
facility: Fullerton Neurology and Headache Center
state: California
city: West Hollywood
country: United States
facility: Regina Berkovich MD PhD INC
state: California
city: Colorado Springs
country: United States
facility: Colorado Springs Neurological Associates, PC - Neurology
state: Colorado
city: Englewood
country: United States
facility: HCA Research Institute
state: Colorado
city: Fort Collins
country: United States
facility: Advanced Neurosciences Research, LLC
state: Colorado
city: Fairfield
country: United States
facility: Associated Neurologists of Southern Connecticut, PC
state: Connecticut
city: Fairfield
country: United States
facility: Yale University
state: Connecticut
city: Maitland
country: United States
facility: Neurology Associates, P. A.
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Orlando
country: United States
facility: Orlando Health Multiple Sclerosis Comprehensive Care Center - Downtown Orlando
state: Florida
city: Saint Petersburg
country: United States
facility: Suncoast Neuroscience and Associates, Inc.
state: Florida
city: Tampa
country: United States
facility: Axiom Clinical Research of Florida
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Rolling Meadows
country: United States
facility: Northwest Neurology Ltd
state: Illinois
city: Springfield
country: United States
facility: Prairie Education & Research
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Neurological Center
state: Indiana
city: Overland Park
country: United States
facility: College Park Family Care Center
state: Kansas
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Bangor
country: United States
facility: Northern Light Comprehensive Multiple Sclerosis Care Center
state: Maine
city: Boston
country: United States
facility: Neurological Clinical Research Institute
state: Massachusetts
city: Foxboro
country: United States
facility: Neuro Institute of New England P.C.
state: Massachusetts
city: Wellesley
country: United States
facility: The Elliot Lewis Center for Multiple Sclerosis Care
state: Massachusetts
city: Worcester
country: United States
facility: UMASS - Neurology
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University (WSU) - Multiple Sclerosis Treatment and Clinical Research Center (MS Center) - Department of Neurology
state: Michigan
city: Farmington Hills
country: United States
facility: Detroit Clinical Research Center, PC
state: Michigan
city: Owosso
country: United States
facility: Memorial Healthcare
state: Michigan
city: Golden Valley
country: United States
facility: Minneapolis Clinic of Neurology - Neurology
state: Minnesota
city: Las Vegas
country: United States
facility: Neurology Center of Las Vegas
state: Nevada
city: Amherst
country: United States
facility: DENT Neurologic Institute
state: New York
city: Brooklyn
country: United States
facility: NYU Langone Brooklyn - Brooklyn
state: New York
city: New York
country: United States
facility: The Trustee of Columbia University in the City of New York
state: New York
city: Charlotte
country: United States
facility: The Charlotte-Mecklenburg Hospital Authority - Carolinas Healthcare System
state: North Carolina
city: Greensboro
country: United States
facility: Guilford Neurologic Associates
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Neurology Associates
state: North Carolina
city: Bellevue
country: United States
facility: Insight Neuroscience LLC
state: Ohio
city: Cincinnati
country: United States
facility: Riverhills Neuroscience
state: Ohio
city: Columbus
country: United States
facility: The Boster Center for Multiple Scelosis
state: Ohio
city: Dayton
country: United States
facility: Dayton Center for Neurological Disorders
state: Ohio
city: Toledo
country: United States
facility: University of Toledo - PARENT
state: Ohio
city: Portland
country: United States
facility: Providence Neurological Specialties
state: Oregon
city: Philadelphia
country: United States
facility: Wills Eye Institute - Ocular Oncology Service - Wills Eye Institute
state: Pennsylvania
city: Greer
country: United States
facility: Premier Neurology Research, P.C.
state: South Carolina
city: Knoxville
country: United States
facility: Neurology, PC
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Cypress
country: United States
facility: Northwest Houston Neurology
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine IRB
state: Texas
city: McAllen
country: United States
facility: DHR Health Neurology Institute Neuroimmunology and Multiple Sclerosis
state: Texas
city: Round Rock
country: United States
facility: Central Texas Neurology Consultants
state: Texas
city: San Antonio
country: United States
facility: Neurology Center of San Antonio
state: Texas
city: Alexandria
country: United States
facility: Integrated Neurology Services - Dr. Simon Fishman's Office
state: Virginia
city: Christiansburg
country: United States
facility: Blacksburg Neurology, PC
state: Virginia
city: Norfolk
country: United States
facility: Meridian Clinical Research (Neurology)
state: Virginia
city: Richmond
country: United States
facility: Neurological Associates
state: Virginia
city: Richmond
country: United States
facility: VCU Medical Center - Pediatric Neurology
state: Virginia
city: Richmond
country: United States
facility: Massey Cancer Center - VCU Medical Center
state: Virginia
city: Vienna
country: United States
facility: Multiple Sclerosis Center of Greater Washington
state: Virginia
city: Virginia Beach
country: United States
facility: Sentara Ambulatory Care Center
state: Virginia
city: Kirkland
country: United States
facility: MS Center of Evergreen
state: Washington
city: Spokane
country: United States
facility: MultiCare Health System Institute for Research and Innovation - MultiCare Health System Institute for Research and
state: Washington
city: Tacoma
country: United States
facility: MultiCare Health System Institute for Research and Innovation - MultiCare Health System Institute for Research
state: Washington
city: Milwaukee
country: United States
facility: Ascension St. Francis Center for Neurological Disorders, S.C.
state: Wisconsin
city: Milwaukee
country: United States
facility: The Medical College of Wisconsin - Endocrinology
state: Wisconsin
city: Neenah
country: United States
facility: Neuroscience Group of Northeast Wisconsin - DUPLICATE
state: Wisconsin
Study officials:
affiliation: EMD Serono Inc., the biopharmaceutical division of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References:
citation: 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.