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Cognition and HRQoL in Adults With Highly-active RMS in Year 3 and 4 After Initial Mavenclad® Dose (CLARIFY MS Extension)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04776213
Recruitment Status : Active, not recruiting
First Posted : March 1, 2021
Last Update Posted : April 27, 2022
Sponsor:
Information provided by (Responsible Party):
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Study Description
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Brief Summary:
The purpose of the study is the evaluation of the effect of a treatment for highly-active relapsing multiple sclerosis (RMS). This is the extension study to CLARIFY MS (NCT03369665), to assess cognitive impairment and health related quality of life (HRQoL) in participants with highly active RMS, at 4 years after initial dose of Mavenclad® tablets.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Mavenclad® Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A 2-year Follow-up Study to Assess Cognition and Health-related Quality of Life in Participants With Highly-active Relapsing Multiple Sclerosis, Having Participated in the CLARIFY MS Trial (CLARIFY MS Extension)
Actual Study Start Date : February 23, 2021
Estimated Primary Completion Date : September 11, 2023
Estimated Study Completion Date : September 11, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Mavenclad® Drug: Mavenclad®
This low interventional extension study involves the follow up of participants in the parent study. The participants will be followed up for an additional 2 year period (until 4 years after initial administration of Mavenclad® tablets), during which the participants are not treated with Mavenclad®, as per European Medicines Agency (EMA) label of Mavenclad®.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With No or Minimal Decline in Cognitive Function, Defined As an Improved or Stable Symbol Digit Modalities Test (SDMT) Score or a Decline of 4 points or Less in the SDMT Score, at 4 Years [ Time Frame: Up to 4 years after initial dose of Mavenclad® in parent study ]

Secondary Outcome Measures :
  1. Change From Baseline in Health Related Quality of Life (HRQoL) as Measured by Multiple Sclerosis Quality of Life 54 Questionnaire (MSQoL-54) Physical and Mental Health Scores at 4 Years [ Time Frame: Baseline (baseline of parent study), 4 years after initial dose of Mavenclad® in parent study ]
  2. Change From Month 24 in Health Related Quality of Life (HRQoL) as Measured by Multiple Sclerosis Quality of Life 54 Questionnaire (MSQoL-54) Physical and Mental Health Scores at 4 Years [ Time Frame: Month 24 after initial dose of Mavenclad® in parent study, 4 years after initial dose of Mavenclad® in parent study ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have at least CLARIFY MS Baseline data on Symbol Digit Modalities Test (SDMT)
  • Received at least a single dose of cladribine tablets in the CLARIFY MS study
  • Completed the Final Study Visit (M24) of the CLARIFY MS study
  • Capable of giving signed informed consent, as indicated in protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol

Exclusion Criteria:

  • Participant is considered by the Investigator and Sponsor, for any reason, to be an unsuitable candidate for the study
  • Participation in other studies.
Contacts and Locations
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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): NCT04776213


Locations
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Sponsors and Collaborators
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Investigators
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Study Director: Medical Responsible Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
More Information
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Additional Information:

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Responsible Party: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT04776213    
Other Study ID Numbers: MS700568_0158
2020-003874-30 ( EudraCT Number )
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: April 27, 2022
Last Verified: April 2022
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, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany 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.merckgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany:
Multiple sclerosis
Health related quality of life
Mavenclad®
Relapsing Multiple Sclerosis
 Cladribine
Cognitive impairment cognition
Fatigue
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