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

• Status: Recruiting
• Trial end date: 2023-12-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
• Treatments: Cladribine

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.