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A Study of Suboptimally Controlled Participants Previously Taking Oral or Infusion Disease-Modifying Drugs (DMDs) for Relapsing Forms of Multiple Sclerosis (RMS) (MASTER-2)

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ClinicalTrials.gov Identifier: NCT03933202
Recruitment Status : Recruiting
First Posted : May 1, 2019
Last Update Posted : November 27, 2019
Sponsor:
Collaborator:
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
EMD Serono ( EMD Serono Research & Development Institute, Inc. )

Brief Summary:
To evaluate the effectiveness and safety 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 DMD approved in the United States (US) for RMS in a real-world-setting.

Condition or disease Intervention/treatment
Multiple Sclerosis Drug: Cladribine Tablets

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cladribine Tablets: Observational Evaluation of Effectiveness and Patient-Reported Outcomes (PROs) in Suboptimally Controlled Patients Previously Taking Oral or Infusion Disease-Modifying Drugs (DMDs) for Relapsing Forms of Multiple Sclerosis (RMS) (MASTER-2)
Actual Study Start Date : July 22, 2019
Estimated Primary Completion Date : May 3, 2023
Estimated Study Completion Date : May 3, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Cladribine

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.




Primary Outcome Measures :
  1. Annualized Relapse Rate (ARR) (Prospective Assessment) [ Time Frame: Baseline (Month 0) up to 24 Months ]
    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.


Secondary Outcome Measures :
  1. Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Total Score at Month 6, 12 and 24 [ Time Frame: Baseline (Month 0), Month 6, 12 and 24 ]
  2. Change From Baseline in 36-Item Short Form Health Survey (SF-36) Total Score at Month 6, 12 and 24 [ Time Frame: Baseline (Month 0), Month 6, 12 and 24 ]
  3. Change From Baseline in Modified Fatigue Impact Scale - 5-item version (MFIS-5) Total Score at Month 6, 12 and 24 [ Time Frame: Baseline (Month 0), Month 6, 12 and 24 ]
  4. Change From Baseline in 7-Item Beck-Depression Inventory-Fast Screen (BDI-FS) Total Score at Month 6, 12 and 24 [ Time Frame: Baseline (Month 0), Month 6, 12 and 24 ]
  5. Change From Baseline in 6-Item Work Productivity Activity Impairment - Multiple Sclerosis (WPAI-MS) Total Score at Month 6, 12 and 24 [ Time Frame: Baseline (Month 0), Month 6, 12 and 24 ]
  6. Change From Baseline in Patient Determined Disease Steps (PDDS) Scale Total Score at Month 6, 12 and 24 [ Time Frame: Baseline (Month 0), Month 6, 12 and 24 ]
  7. Number of Participants With Adherence to Treatment as Assessed by Modified Versions of the Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ) [ Time Frame: Baseline (Month 0) and at the end of Months 1, 2, 13 and 14 ]
  8. Percentage of Participants with Relapse (Prospective Assessment) [ Time Frame: Month 12 and 24 ]
    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.

  9. Percentage of Participants With Relapse Associated With Hospitalization, Diagnosis or Reason for Hospitalization [ Time Frame: Month 12 and 24 ]
    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.

  10. Percentage of Participants With Relapse Associated With Glucocorticoid Use [ Time Frame: Month 12 and 24 ]
    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.

  11. Treatment Pattern as Evaluated by Number of Participants With Previous Treatment for Multiple Sclerosis (MS) [ Time Frame: At Baseline (Month 0) ]
  12. Percentage of Participants Who Discontinue Cladribine Tablets [ Time Frame: Baseline (Month 0) up to 24 Months ]
  13. Percentage of Participants With Reason for Discontinuation of Cladribine Tablets [ Time Frame: Baseline (Month 0) up to 24 Months ]
  14. Elapsed Time to Discontinuation After First Dose of Cladribine Tablets [ Time Frame: Baseline (Month 0) up to 24 Months ]
  15. Number of Doses Received by Participants as per United States Prescribing Information [ Time Frame: Baseline (Month 0) up to 24 Months ]
  16. Percentage of Planned Doses Received by Participants as per United States Prescribing Information [ Time Frame: Baseline (Month 0) up to 24 Months ]
  17. Number of Participants with Subsequent Treatment Chosen Following Discontinuation of Cladribine Tablets [ Time Frame: Baseline (Month 0) up to 24 Months ]
  18. Number of Participants Assessed of Concomitant Multiple Sclerosis Medications Used During Study Period [ Time Frame: Baseline (Month 0) up to 24 Months ]
  19. Annualized Relapse Rate (ARR) (Retrospective Assessment) [ Time Frame: Up to 24 Months prior Baseline (Month 0) ]
    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.

  20. Number of Participants With Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Adverse Events of Special Interest (AESIs) and Special Situations [ Time Frame: Baseline (Month 0) up to 24 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).
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 3 months
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03933202


Contacts
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Contact: US Medical Information 888-275-7376 service@emdgroup.com

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

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Responsible Party: EMD Serono Research & Development Institute, Inc.
ClinicalTrials.gov Identifier: NCT03933202     History of Changes
Other Study ID Numbers: MS700568_0079
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html
Keywords provided by EMD Serono ( EMD Serono Research & Development Institute, Inc. ):
Multiple Sclerosis
Cladribine Tablets
Observational
Mavenclad
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Cladribine
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs