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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49089

Enrollment

Registered

2021-01-18

Start date

2021-09-09

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

encephalomyelitis disseminata Multiple sclerosis (MS)

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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 after initial dose of cladribine tablets (M48) compared to SDMT score prior to initial dose of cladribine tablets (CLARIFY MS Baseline)	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results