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

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 4

Conditions: Multiple Sclerosis

Treatments: Drug: Mavenclad®

Study type: Interventional

Funder types: Industry

Identifiers

NCT04776213

2020-003874-30 (EudraCT Number)

MS700568_0158

Details and patient eligibility

About

The purpose of the study was the evaluation of the effect of a treatment for highly-active relapsing multiple sclerosis (RMS). This was 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.

Enrollment: 280 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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280 participants in 1 patient group

Mavenclad®

Experimental group

Treatment:

Drug: Mavenclad®