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

Phase 4

Completed

Conditions: 10007963
Multiple sclerosis (MS)
encephalomyelitis disseminata

Registration Number: NL-OMON49089

Lead Sponsor: Merck

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 9

Inclusion Criteria

1. Participants having participated in the CLARIFY MS trial, who:
a. Have at least CLARIFY MS Baseline data on SDMT;
b. Received at least a single dose of cladribine tablets in the CLARIFY MS
trial; and
c. Completed the Final Study Visit (M24) of the CLARIFY MS trial.
2. Capable of giving signed informed consent, which includes compliance with
the requirements and restrictions listed in the informed consent form (ICF) and
this protocol.

Exclusion Criteria

1. Participant is considered by the Investigator and Sponsor, for any reason,
to be an unsuitable candidate for the study.
2. Participation in other studies/trials.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Percentage of participants with no or minimal decline in cognitive function,<br /><br>defined<br /><br>as an improved or stable Symbol Digit Modalities Test (SDMT) score<br /><br>or a decline of 4 points or less in the SDMT score, at 4 years after initial<br /><br>dose of cladribine<br /><br>tablets (M48) compared to SDMT score prior to initial dose of cladribine tablets<br /><br>(CLARIFY MS Baseline)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Change in HRQoL as measured by Multiple Sclerosis Quality of Life<br /><br>54 Questionnaire (MSQoL-54) physical and mental health scores at 4 years<br /><br>after initial dose of cladribine tablets (M48) compared to prior to initial<br /><br>dose of<br /><br>cladribine tablets (CLARIFY MS Baseline)<br /><br>• Change in HRQoL as measured by MSQoL-54 physical and mental health<br /><br>scores at 4 years after initial dose of cladribine tablets (M48) compared to<br /><br>M24</p><br>