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)

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: Cladribine Tablets

• Study Type: Observational
• Enrollment (Actual): 291

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Cullman, Alabama, United States, 35058
      • North Central Neurology Associates, P.C.
    • Mobile, Alabama, United States, 36693
      • University of South Alabama
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences
  • California
    • Fullerton, California, United States, 92835
      • Fullerton Neurology and Headache Center
    • West Hollywood, California, United States, 90048
      • Regina Berkovich MD PhD Inc
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Colorado Springs Neurological Associates, PC - Neurology
    • Englewood, Colorado, United States, 80113
      • HCA Research Institute
    • Fort Collins, Colorado, United States, 80528
      • Advanced Neurosciences Research, LLC
  • Connecticut
    • Fairfield, Connecticut, United States, 06824
      • Yale University
    • Fairfield, Connecticut, United States, 06824
      • Associated Neurologists of Southern Connecticut, PC
  • Florida
    • Maitland, Florida, United States, 32751
      • Neurology Associates, P. A.
    • Miami, Florida, United States, 33136
      • University of Miami
    • Orlando, Florida, United States, 32806
      • Orlando Health Multiple Sclerosis Comprehensive Care Center - Downtown Orlando
    • St. Petersburg, Florida, United States, 33713
      • Suncoast Neuroscience and Associates, Inc.
    • Tampa, Florida, United States, 33609
      • Axiom Clinical Research of Florida
    • Tampa, Florida, United States, 33612
      • University of South Florida
  • Illinois
    • Rolling Meadows, Illinois, United States, 60008
      • Northwest Neurology Ltd
    • Springfield, Illinois, United States, 62702
      • Prairie Education & Research
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Fort Wayne Neurological Center
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • College Park Family Care Center
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Lexington
  • Maine
    • Bangor, Maine, United States, 04401
      • Northern Light Comprehensive Multiple Sclerosis Care Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Neurological Clinical Research Institute
    • Foxborough, Massachusetts, United States, 02035
      • Neuro Institute of New England P.C.
    • Wellesley, Massachusetts, United States, 02481
      • The Elliot Lewis Center for Multiple Sclerosis Care
    • Worcester, Massachusetts, United States, 01655
      • UMASS - Neurology
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University (WSU) - Multiple Sclerosis Treatment and Clinical Research Center (MS Center) - Department of Neurology
    • Farmington Hills, Michigan, United States, 48334
      • Detroit Clinical Research Center, PC
    • Owosso, Michigan, United States, 48867
      • Memorial Healthcare
  • Minnesota
    • Golden Valley, Minnesota, United States, 55422
      • Minneapolis Clinic of Neurology - Neurology
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Neurology Center of Las Vegas
  • New York
    • Amherst, New York, United States, 14226
      • Dent Neurologic Institute
    • Brooklyn, New York, United States, 11220
      • NYU Langone Brooklyn - Brooklyn
    • New York, New York, United States, 10032
      • The Trustee of Columbia University in the City of New York
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • The Charlotte-Mecklenburg Hospital Authority - Carolinas Healthcare System
    • Greensboro, North Carolina, United States, 27405
      • Guilford Neurologic Associates
    • Raleigh, North Carolina, United States, 27607-6010
      • Raleigh Neurology Associates
  • Ohio
    • Bellevue, Ohio, United States, 44811
      • Insight Neuroscience LLC
    • Cincinnati, Ohio, United States, 45212
      • Riverhills Neuroscience
    • Columbus, Ohio, United States, 43235
      • The Boster Center for Multiple Scelosis
    • Dayton, Ohio, United States, 45459
      • Dayton Center for Neurological Disorders
    • Toledo, Ohio, United States, 43614-2598
      • University of Toledo - PARENT
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence Neurological Specialties
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Wills Eye Institute - Ocular Oncology Service - Wills Eye Institute
  • South Carolina
    • Greer, South Carolina, United States, 29650
      • Premier Neurology Research, P.C.
  • Tennessee
    • Knoxville, Tennessee, United States, 37922
      • Neurology, PC
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Cypress, Texas, United States, 77429
      • Northwest Houston Neurology
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine IRB
    • McAllen, Texas, United States, 78503
      • DHR Health Neurology Institute Neuroimmunology and Multiple Sclerosis
    • Round Rock, Texas, United States, 78681
      • Central Texas Neurology Consultants
    • San Antonio, Texas, United States, 78258
      • Neurology Center of San Antonio
  • Virginia
    • Alexandria, Virginia, United States, 22310
      • Integrated Neurology Services - Dr. Simon Fishman's Office
    • Christiansburg, Virginia, United States, 24073
      • Blacksburg Neurology, PC
    • Norfolk, Virginia, United States, 23502
      • Meridian Clinical Research (Neurology)
    • Richmond, Virginia, United States, 23226
      • Neurological Associates
    • Richmond, Virginia, United States, 23298
      • Massey Cancer Center - VCU Medical Center
    • Richmond, Virginia, United States, 23298-0211
      • VCU Medical Center - Pediatric Neurology
    • Vienna, Virginia, United States, 22182
      • Multiple Sclerosis Center of Greater Washington
    • Virginia Beach, Virginia, United States, 23456
      • Sentara Ambulatory Care Center
  • Washington
    • Kirkland, Washington, United States, 98034
      • MS Center of Evergreen
    • Spokane, Washington, United States, 99202
      • MultiCare Health System Institute for Research and Innovation - MultiCare Health System Institute for Research and
    • Tacoma, Washington, United States, 98405
      • MultiCare Health System Institute for Research and Innovation - MultiCare Health System Institute for Research
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Ascension St. Francis Center for Neurological Disorders, S.C.
    • Milwaukee, Wisconsin, United States, 53226
      • The Medical College of Wisconsin - Endocrinology
    • Neenah, Wisconsin, United States, 54956
      • Neuroscience Group of Northeast Wisconsin - DUPLICATE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24	The TSQM-14 was a participant-rated scale used to assess subjective satisfaction with medication. The TSQM has 14 questions that assesses participants' global satisfaction level with their treatment in 4 domains: side effects (There are 5 questions in the side effects domain, however one of them is a Yes/No question and there are 4 sub-components, hence a maximum score of 20), effectiveness (3 questions), global satisfaction (3 questions), and convenience (3 questions). All questions are scored from 1 (least satisfied) to 5 or 7 (most satisfied). The total score is summed for each domain to obtain: side effects (1-20), effectiveness (1-21), global satisfaction (1-17), and convenience (1-21), using transformed scores between 0 and 100. Lower total scores in each domain indicate dissatisfaction with the study medication and higher total scores indicate satisfaction.	Baseline (Month 0), Month 6, 12 and 24
Percentage of Participants Who Discontinued Cladribine Tablets	Percentage of participants who discontinued cladribine tablets were reported.	Baseline (Month 0) up to 24 Months
Number of Doses Received by Participants as Per United States Prescribing Information	Number of doses received by participants as per United States prescribing information were reported.	Baseline (Month 0) up to 24 Months
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Domain Score at Month 6, 12 and 24	The SF-36 Health Survey is a validated, self-administered questionnaire designed to assess general health status across eight domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It includes one item evaluating perceived change in health over the past year and generates two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-derived using factor analytic methods. Each domain and summary score is scaled from 0 to 100, with higher scores indicating better health status.	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	The MFIS-5 is a shortened version of the Fatigue Impact Scale consisting of 5 items that assess the impact of fatigue on physical, cognitive, and psychosocial functioning. Each item is rated on a 5-point Likert scale: 0 (Never), 1 (Rarely), 2 (Sometimes), 3 (Often), and 4 (Almost always). The total score ranges from 0 to 20, with higher scores indicating a greater impact of fatigue. Items include: reduced alertness, limitations in activities away from home, difficulty sustaining physical effort, reduced ability to complete tasks requiring physical effort, and trouble concentrating.	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	The 7-item Beck Depression Inventory-Fast Screen (BDI-FS) is a self-report tool used to assess the severity of depressive symptoms. It includes seven items: Sadness, Pessimism, Past Failure, Loss of Pleasure, Self-Dislike, Self-Criticalness, and Suicidal Thoughts. Each item is rated on a 4-point scale from 0 to 3, with higher scores indicating greater symptom severity. The total score ranges from 0 to 21 and is calculated by summing the highest-rated response for each item.	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	The WPAI-MS questionnaire is a 6-item validated instrument to measure impairments in work and activities. The WPAI-MS included 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI-MS generated four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Change from baseline in percentage of work time missed (absenteeism) was reported.	Baseline (Month 0), Month 6, 12 and 24
Change From Baseline in Percentage of Impairment While Working Assessed by 6-Item Work Productivity Activity Impairment - Multiple Sclerosis (WPAI-MS) Score at Month 6, 12 and 24	The WPAI-MS questionnaire is a 6-item validated instrument to measure impairments in work and activities. The WPAI-MS included 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI-MS generated four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Change from baseline in percentage of impairment while working (presentisms) was reported.	Baseline (Month 0), Month 6, 12 and 24
Change From Baseline in Percentage of Overall Work Impairment Assessed by 6-Item Work Productivity Activity Impairment - Multiple Sclerosis (WPAI-MS) Score at Month 6, 12 and 24	The WPAI-MS questionnaire is a 6-item validated instrument to measure impairments in work and activities. The WPAI-MS included 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI-MS generated four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Change from baseline in total percentage of work impairment (absenteeism and presentisms) were reported.	Baseline (Month 0), Month 6, 12 and 24
Change From Baseline in Percentage of Activity Impairment Assessed by 6-Item Work Productivity Activity Impairment- Multiple Sclerosis (WPAI-MS) Score at Month 6, 12 and 24	The WPAI-MS questionnaire is a 6-item validated instrument to measure impairments in work and activities. The WPAI-MS included 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI-MS generated four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Change from baseline in percentage of activity impairment was reported.	Baseline (Month 0), Month 6, 12 and 24
Change From Baseline in Patient Determined Disease Steps (PDDS) Scale Total Score at Month 6, 12 and 24	The PDDS is a patient-reported scale to assess the disability status in participants with MS, and it focuses mainly on how participants walk. Scores on the PDDS range from 0 (normal) to 8 (bedridden): 0 (Normal), 1 (Mild Disability), 2 (Moderate Disability), 3 (Gait Disability), 4 (Early Cane), 5 (Late Cane), 6 (Bilateral Support), 7 (Wheelchair/Scooter), and 8 (Bedridden). A higher score represents higher level of disability.	Baseline (Month 0), Month 6, 12 and 24
Number of Participants With Adherence to Treatment as Assessed by Modified Versions of the Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ)	7 Treatment adherence questions, based on MS-TAQ, were developed to determine level of adherence as well as identify barriers to adherence for MS participants taking DMDs. 1.What treatment week of cladribine (Clad.) tablets (tab.) did you most recently complete? 2.How many Clad. tab. were you supposed to take during this treatment week? 3.Did you miss/forget to take any Clad. tab. during this treatment week? 4. How many Clad. tab. did you miss/ forget to take? 5.How important were following factors in missing/forgetting to take a dose? (scale from 0-3, where, 0=Not important at all and 3=Extremely important). 6.Overall, how hard/easy do you feel it is to take Clad. tab. as recommended by your physician during your treatment week? (scale from 1- 5, where 1=Extremely easy and 5=Extremely hard). 7.How satisfied are you with how things have been with your Clad. tab. treatment during your treatment week? (scale from 1-5, where 1=Not satisfied at all and 5=Completely satisfied).	Month 1, 2, 13 and 14
Number of Participants Who Experienced Relapse	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.	Over the 12-month and 24-month period
Percentage of Participants With Relapse Associated With Hospitalization	A relapse was defined according to routine clinical practice as determined by the investigator. A relapse will be associated with hospitalization if the participants will be hospitalized for the relapse. As a guide, relapse was considered an exacerbation of symptoms that occurred over a minimum of 24 hours and was separated from a previous attack by at least 30 days, in the absence of fever or infection. The percentage of participants who experienced a relapse associated with hospitalization was reported.	Over the 12-month period, 13th to 24th month and over the 24 month period.
Annualized Relapse Rate (ARR) Associated With Hospitalization at Months 12 and 24	The qualifying relapse is the occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis (MS) (for more than [>] 24 hours, no fever, infection, injury, adverse events (AEs), and preceded by a stable or improving neurological state for more than or equal to [>=] 30 days).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. ARR associated with hospitalization at Months 12 and 24 were reported. A relapse was associated with hospitalization if the participant will be hospitalized for the relapse.	Month 12 and Month 24
Percentage of Participants With Relapse Associated With Glucocorticoid Use	A relapse was defined according to routine clinical practice as determined by the investigator. As a guide, relapse was considered an exacerbation of symptoms that occurred over a minimum of 24 hours and was separated from a previous attack by at least 30 days, in the absence of fever or infection. The percentage of participants with relapse associated with glucocorticoid use over the 12-month period, 13th to 24th month and over the 24-month period of treatment with cladribine tablets was reported.	Over the 12-month period, 13th to 24th month and over the 24 month period.
Annualized Relapse Rate (ARR) Associated With Glucocorticoid Use at Months 12 and 24	The qualifying relapse is the occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis (MS) (for more than [>] 24 hours, no fever, infection, injury, adverse events (AEs), and preceded by a stable or improving neurological state for more than or equal to [>=] 30 days). 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. ARR associated with glucocorticoid use at Months 12 and 24 were reported. A relapse will be associated with glucocorticoid use if steroid treatment will be required for the relapse.	Months 12 and 24
Number of Previous Disease-Modifying Drugs (DMD) Received for Multiple Sclerosis (MS) at Baseline	Number of previous DMD received by participants with MS were reported.	At Baseline (Month 0)
Number of Participants With Reason for Discontinuation of Cladribine Tablets	Number of participants who discontinued cladribine tablets in each category of reason for discontinuation were reported.	Baseline (Month 0) up to 24 Months
Elapsed Time to Discontinuation After First Dose of Cladribine Tablets	Elapsed time to discontinuation after first dose of cladribine tablets was reported. Elapsed time to discontinuation of cladribine tablets is calculated by subtracting the date of the first study dose from the date on which the participant discontinued cladribine tablets.	Baseline (Month 0) up to 24 Months
Total Planned Doses Received by Participants as Per United States Prescribing Information	Total planned doses received by participants as per United States Prescribing Information was reported.	Baseline (Month 0) up to 24 Months
Percentage of Participants With Subsequent Treatment Chosen Following Discontinuation of Cladribine Tablets	Percentage of participants with subsequent treatment chosen following discontinuation of cladribine tablets was reported. The percentages were calculated using the number of participants who discontinued Cladribine tablets as denominator.	Baseline (Month 0) up to 24 Months
Number of Participants With At Least One Concomitant Medication	Number of participants with at least one concomitant medication were reported.	Baseline (Month 0) up to 24 Months
Annualized Relapse Rate (ARR)	A relapse was defined as an exacerbation of symptoms that occurred over a minimum of 24 hours and was separated from a previous attack by at least 30 days, in the absence of fever or infection. Annualized relapse rate (ARR) during the 24 months prior to baseline, based on retrospectively collected data, was reported. 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.	Up to 24 Months prior Baseline (Month 0)
Number of Participants With Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and Adverse Events of Special Interest (AESIs)	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. Special Situations included AEs related to pregnancy, overdose, off-label use, misuse, medication error, occupational exposure, or lack of therapeutic effectiveness.	Baseline (Month 0) up to 24 months

Collaborators and Investigators

• Sponsor: EMD Serono Research & Development Institute, Inc.
• Collaborators: Merck KGaA, Darmstadt, Germany
• Investigators: Study Director: Medical Responsible, EMD Serono Inc., the biopharmaceutical division of Merck KGaA, Darmstadt, Germany

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2019
• Primary Completion (Actual): November 11, 2024
• Study Completion (Actual): November 11, 2024

Study Registration Dates

• First Submitted: April 29, 2019
• First Submitted That Met QC Criteria: April 29, 2019
• First Posted (Actual): May 1, 2019

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Observational; Cladribine Tablets; Mavenclad
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nucleic Acids, Nucleotides, and Nucleosides; Purines; Nucleosides; Ribonucleosides; Deoxyribonucleosides; 2-Chloroadenosine; Adenosine; Purine Nucleosides; Deoxyadenosines; Cladribine
• Other Study ID Numbers: MS700568_0079