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

Multiple Sclerosis Clinical Trial

Official title:

Cladribine Tablets: Observational Evaluation of Effectiveness and PROs in Suboptimally Controlled Patients Previously Taking Oral or Infusion DMDs for RMS (MASTER-2)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03933202
• Other study ID #: MS700568_0079
• Status: Active, not recruiting
• Start date: July 22, 2019
• Est. completion date: November 15, 2026

Study information

• Verified date: May 2024
• Source: EMD Serono
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 295
• Est. completion date: November 15, 2026
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Cladribine Tablets
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.

Locations

Country	Name	City	State
United States	Integrated Neurology Services - Dr. Simon Fishman's Office	Alexandria	Virginia
United States	DENT Neurologic Institute	Amherst	New York
United States	Northern Light Comprehensive Multiple Sclerosis Care Center	Bangor	Maine
United States	Insight Neuroscience LLC	Bellevue	Ohio
United States	Neurological Clinical Research Institute	Boston	Massachusetts
United States	Blacksburg Neurology, PC	Christiansburg	Virginia
United States	Colorado Springs Neurological Associates, PC - Neurology	Colorado Springs	Colorado
United States	North Central Neurology Associates, P.C.	Cullman	Alabama
United States	Dayton Center for Neurological Disorders	Dayton	Ohio
United States	Wayne State University (WSU) - Multiple Sclerosis Treatment and Clinical Research Center (MS Center) - Department of Neurology	Detroit	Michigan
United States	Associated Neurologists of Southern Connecticut, PC	Fairfield	Connecticut
United States	Detroit Clinical Research Center, PC	Farmington Hills	Michigan
United States	Advanced Neurosciences Research, LLC	Fort Collins	Colorado
United States	Fort Wayne Neurological Center	Fort Wayne	Indiana
United States	Neuro Institute of New England P.C.	Foxboro	Massachusetts
United States	Fullerton Neurology and Headache Center	Fullerton	California
United States	Minneapolis Clinic of Neurology - Neurology	Golden Valley	Minnesota
United States	Guilford Neurologic Associates	Greensboro	North Carolina
United States	Premier Neurology Research, P.C.	Greer	South Carolina
United States	MS Center of Evergreen	Kirkland	Washington
United States	Neurology Center of Las Vegas	Las Vegas	Nevada
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Neurology Associates, P. A.	Maitland	Florida
United States	DHR Health Neurology Institute Neuroimmunology and Multiple Sclerosis	McAllen	Texas
United States	Ascension St. Francis Center for Neurological Disorders, S.C.	Milwaukee	Wisconsin
United States	The Medical College of Wisconsin - Endocrinology	Milwaukee	Wisconsin
United States	University of South Alabama	Mobile	Alabama
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Neuroscience Group of Northeast Wisconsin - DUPLICATE	Neenah	Wisconsin
United States	The Trustee of Columbia University in the City of New York	New York	New York
United States	Meridian Clinical Research (Neurology)	Norfolk	Virginia
United States	Orlando Health Multiple Sclerosis Comprehensive Care Center - Downtown Orlando	Orlando	Florida
United States	College Park Family Care Center	Overland Park	Kansas
United States	Memorial Healthcare	Owosso	Michigan
United States	Providence Neurological Specialties	Portland	Oregon
United States	Raleigh Neurology Associates	Raleigh	North Carolina
United States	Neurological Associates	Richmond	Virginia
United States	Northwest Neurology Ltd	Rolling Meadows	Illinois
United States	Central Texas Neurology Consultants	Round Rock	Texas
United States	Neurology Center of San Antonio	San Antonio	Texas
United States	MultiCare Health System Institute for Research and Innovation - MultiCare Health System Institute for Research and	Spokane	Washington
United States	Prairie Education & Research	Springfield	Illinois
United States	MultiCare Health System Institute for Research and Innovation - MultiCare Health System Institute for Research	Tacoma	Washington
United States	Axiom Clinical Research of Florida	Tampa	Florida
United States	University of South Florida	Tampa	Florida
United States	Multiple Sclerosis Center of Greater Washington	Vienna	Virginia
United States	Sentara Ambulatory Care Center	Virginia Beach	Virginia
United States	The Elliot Lewis Center for Multiple Sclerosis Care	Wellesley	Massachusetts
United States	Regina Berkovich MD PhD INC	West Hollywood	California
United States	UMASS - Neurology	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
EMD Serono Research & Development Institute, Inc.	Merck KGaA, Darmstadt, Germany

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annualized Relapse Rate (ARR) (Prospective Assessment)	A relapse will be 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 up to 24 months of treatment with cladribine tablets, after baseline (prospectively collected data) will be reported.	Baseline (Month 0) up to 24 Months
Secondary	Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Total Score at Month 6, 12 and 24		Baseline (Month 0), Month 6, 12 and 24
Secondary	Change From Baseline in 36-Item Short Form Health Survey (SF-36) Total Score at Month 6, 12 and 24		Baseline (Month 0), Month 6, 12 and 24
Secondary	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
Secondary	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
Secondary	Change From Baseline in 6-Item Work Productivity Activity Impairment - Multiple Sclerosis (WPAI-MS) Total Score at Month 6, 12 and 24		Baseline (Month 0), Month 6, 12 and 24
Secondary	Change From Baseline in Patient Determined Disease Steps (PDDS) Scale Total Score at Month 6, 12 and 24		Baseline (Month 0), Month 6, 12 and 24
Secondary	Number of Participants With Adherence to Treatment as Assessed by Modified Versions of the Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ)		Baseline (Month 0) and at the end of Months 1, 2, 13 and 14
Secondary	Percentage of Participants with Relapse (Prospective Assessment)	A relapse will be 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. Percentage of participants with relapse up to 24 months of treatment with cladribine tablets, after baseline (prospectively collected data) will be reported.	Month 12 and 24
Secondary	Percentage of Participants With Relapse Associated With Hospitalization, Diagnosis or Reason for Hospitalization	A relapse will be 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. Percentage of participants with relapse associated with hospitalization, diagnosis or reason for hospitalization will be reported.	Month 12 and 24
Secondary	Percentage of Participants With Relapse Associated With Glucocorticoid Use	A relapse will be 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. Percentage of participants with relapse associated with glucocorticoid use up to 24 months of treatment with cladribine tablets, after baseline (prospectively collected data) will be reported.	Month 12 and 24
Secondary	Treatment Pattern as Evaluated by Number of Participants With Previous Treatment for Multiple Sclerosis (MS)		At Baseline (Month 0)
Secondary	Percentage of Participants Who Discontinue Cladribine Tablets		Baseline (Month 0) up to 24 Months
Secondary	Percentage of Participants With Reason for Discontinuation of Cladribine Tablets		Baseline (Month 0) up to 24 Months
Secondary	Elapsed Time to Discontinuation After First Dose of Cladribine Tablets		Baseline (Month 0) up to 24 Months
Secondary	Number of Doses Received by Participants as per United States Prescribing Information		Baseline (Month 0) up to 24 Months
Secondary	Percentage of Planned Doses Received by Participants as per United States Prescribing Information		Baseline (Month 0) up to 24 Months
Secondary	Number of Participants with Subsequent Treatment Chosen Following Discontinuation of Cladribine Tablets		Baseline (Month 0) up to 24 Months
Secondary	Number of Participants Assessed of Concomitant Multiple Sclerosis Medications Used During Study Period		Baseline (Month 0) up to 24 Months
Secondary	Annualized Relapse Rate (ARR) (Retrospective Assessment)	A relapse will 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 up to 24 months prior to baseline (retrospectively collected data) will be reported.	Up to 24 Months prior Baseline (Month 0)
Secondary	Number of Participants With Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Adverse Events of Special Interest (AESIs) and Special Situations	A serious adverse event (SAE) is an adverse event (AE) that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or is otherwise considered medically important. An ADR is a response to a medicinal product which is noxious and unintended. An AESI is an AE of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor can be appropriate.	Baseline (Month 0) up to 24 months

External Links

•   Trial Awareness and Transparency website