CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 280 enrolled
Drug / intervention
Mavenclad®drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04776213
NCT04776213Phase 4Completed
CompareCT.gov

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)

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany·interventional·Posted Mar 1, 2021·Updated May 28, 2024

In Brief

A Phase 4 clinical trial evaluating Mavenclad® for Multiple Sclerosis. Completed, enrolled 280 participants across 60 sites in 10 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis
CountriesAustria, Czechia, Denmark, France, Hungary, Italy, Netherlands, Poland, Slovakia, Spain
Collaborators--

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedMar 1, 2021
Enrollment StartFeb 23, 2021
Primary CompletionJun 20, 2023
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 5.3 years ago

Interventions

Mavenclad®drug

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®.