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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

A Study of Suboptimally Controlled Participants Previously Taking Injectable DMDs for RMS (CLICK-MS)

Clinicaltrials.gov identifier NCT03933215

Recruitment Status Recruiting

First Posted May 1, 2019

Last update posted May 10, 2021

Study Description

Brief summary:

To evaluate the effectiveness, patient-reported outcomes (PROs) and safety of cladribine tablets in participants with relapsing forms of multiple sclerosis (RMS) including relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis (aSPMS),who transition to cladribine tablets after suboptimal response to any injectable disease-modifying drugs (DMDs) approved in the United States (US) for RMS in a real-world setting.

  • Condition or Disease:Multiple Sclerosis
  • Intervention/Treatment: Drug: Cladribine Tablets
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational
  • Estimated Enrollment: 136 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: Cladribine Tablets: Observational Evaluation of Effectiveness and PROs in Suboptimally Controlled Patients Previously Taking Injectable DMDs for RMS (CLICK-MS)
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: November 2023
  • Estimated Study Completion Date: November 2023
Groups and Cohorts
Groups/Cohorts 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 injectable 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.
Outcome Measures
  • Primary Outcome Measures: 1. Annualized Relapse Rate (ARR) (Prospective Assessment) [ Time Frame: Baseline (Month 0) up to 24 Months ]
    For this study, 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 ]
    For this study, 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 ]
    For this study, 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 ]
    For this study, 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) ]
    For this study, 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 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.
Eligibility Criteria
  • 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 Multiple Sclerosis and experienced suboptimal response (lack of effectiveness, intolerability, poor adherence) to prior treatment with an injectable DMD.
Criteria

Inclusion Criteria:

- Male or female participants greater than or equal to (>=)18 years

- 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

- Had received their last previous injectable disease-modifying drug (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

- In the opinion of the Investigator, experienced suboptimal response (lack of
effectiveness, intolerability, poor adherence) to injectable DMD treatment

Exclusion Criteria:

- Have been previously treated with cladribine in any dosing form

- Transitioning from previous injectable 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 the cladribine treatment period

Contacts and Locations
Contacts

Contact: US Medical Information 888-275-7376 eMediUSA@emdserono.com

Locations
Show 49 Study Locations
Sponsors and Collaborators

EMD Serono Research & Development Institute, Inc.

Merck KGaA, Darmstadt, Germany

Investigators

Study Director: Medical Responsible EMD Serono Inc., the biopharmaceutical division of Merck KGaA, Darmstadt, Germany

More Information
  • Responsible Party: EMD Serono Research & Development Institute, Inc.
  • ClinicalTrials.gov Identifier: NCT03933215 History of Changes
  • Other Study ID Numbers: MS700568_0078
  • First Posted: May 1, 2019 Key Record Dates
  • Last Update Posted: May 10, 2021
  • Last Verified: May 2021
  • 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 Research & Development Institute, Inc.: Multiple Sclerosis
    Cladribine Tablets
    Observational
    Mavenclad
  • Additional relevant MeSH terms: Multiple Sclerosis Sclerosis