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

  • STATUS
    Recruiting
  • End date
    Dec 29, 2023
  • participants needed
    320
  • sponsor
    Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Updated on 16 September 2021
cladribine
relapsing multiple sclerosis

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.

Details
Condition Multiple Sclerosis, Radiologically Isolated Syndrome, Dermatite Atopique modérée ou grave, multiple sclerosis (ms)
Treatment Mavenclad®
Clinical Study IdentifierNCT04776213
SponsorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Last Modified on16 September 2021

Eligibility

Yes No Not Sure

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
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