NCT04776213

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

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: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Mavenclad®	This low interventional extension study involves the follow up of participants in the parent study. The participants were followed up for an additional 2 year period (until 4 years after initial administration of Mavenclad® tablets), during which the participants were not treated with Mavenclad®, as per European Medicines Agency (EMA) label of Mavenclad®.

Timeline

• Start date: 2021-02-23
• Primary completion: 2023-06-20
• Completion: 2023-06-20
• First posted: 2021-03-01
• Last updated: 2024-05-28
• Results posted: 2024-05-28

Locations

60 sites across 10 countries: Austria, Czechia, Denmark, France, Hungary, Italy, Netherlands, Poland, Slovakia, Spain