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Trial record 7 of 8 for:    mavenclad | multiple sclerosis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03933202
Recruitment Status : Recruiting
First Posted : May 1, 2019
Last Update Posted : November 12, 2020
Sponsor:
Collaborator:
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
EMD Serono ( EMD Serono Research & Development Institute, Inc. )

Tracking Information
First Submitted Date April 29, 2019
First Posted Date May 1, 2019
Last Update Posted Date November 12, 2020
Actual Study Start Date July 22, 2019
Estimated Primary Completion Date May 3, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 29, 2019)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 29, 2019)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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.
  • 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.
  • 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.
  • Treatment Pattern as Evaluated by Number of Participants With Previous Treatment for Multiple Sclerosis (MS) [ Time Frame: At Baseline (Month 0) ]
  • Percentage of Participants Who Discontinue Cladribine Tablets [ Time Frame: Baseline (Month 0) up to 24 Months ]
  • Percentage of Participants With Reason for Discontinuation of Cladribine Tablets [ Time Frame: Baseline (Month 0) up to 24 Months ]
  • Elapsed Time to Discontinuation After First Dose of Cladribine Tablets [ Time Frame: Baseline (Month 0) up to 24 Months ]
  • Number of Doses Received by Participants as per United States Prescribing Information [ Time Frame: Baseline (Month 0) up to 24 Months ]
  • Percentage of Planned Doses Received by Participants as per United States Prescribing Information [ Time Frame: Baseline (Month 0) up to 24 Months ]
  • Number of Participants with Subsequent Treatment Chosen Following Discontinuation of Cladribine Tablets [ Time Frame: Baseline (Month 0) up to 24 Months ]
  • Number of Participants Assessed of Concomitant Multiple Sclerosis Medications Used During Study Period [ Time Frame: Baseline (Month 0) up to 24 Months ]
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study of Suboptimally Controlled Participants Previously Taking Oral or Infusion Disease-Modifying Drugs (DMDs) for Relapsing Forms of Multiple Sclerosis (RMS)
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)
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants with relapsing form of Multiple Sclerosis (RMS) including active secondary progressive multiple sclerosis (aSPMS).
Condition Multiple 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.
Study Groups/Cohorts 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.
Intervention: Drug: Cladribine Tablets
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 28, 2020)
250
Original Estimated Enrollment
 (submitted: April 29, 2019)
200
Estimated Study Completion Date May 3, 2023
Estimated Primary Completion Date May 3, 2023   (Final data collection date for primary outcome measure)
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 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: US Medical Information 888-275-7376 eMediUSA@emdserono.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03933202
Other Study ID Numbers MS700568_0079
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
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
Responsible Party EMD Serono ( EMD Serono Research & Development Institute, Inc. )
Study 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
PRS Account EMD Serono
Verification Date November 2020