CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 485 enrolled
Drug / intervention
Mavenclad®drug
Likely dose
Mavenclad® 3.5 milligramfrom 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/NCT03369665
NCT03369665Phase 4Completed

A 2-Year Prospective Study to Assess Health-related Quality of Life In Subjects With Highly-Active Relapsing Multiple Sclerosis Treated With Mavenclad® (CLARIFY MS)

Merck KGaA, Darmstadt, Germany·interventional·Posted Dec 12, 2017·Updated Sep 14, 2023

In Brief

A Phase 4 clinical trial evaluating Mavenclad® for Multiple Sclerosis. Completed, enrolled 485 participants across 92 sites in 18 countries.

Detailed Summary

The main purpose of the study was to assess the health-related quality of life (HRQoL) through the Multiple Sclerosis Quality of Life-54 Questionnaire (MSQoL-54) scale in highly-active relapsing multiple sclerosis (RMS) particpants treated with Mavenclad® for 2 years (24 months).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Belgium, Czechia, Denmark, Finland, France, Greece, Hungary, Italy, Lithuania, Netherlands, Norway, Poland, Portugal, Slovakia, Spain, Sweden, United Kingdom
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedDec 12, 2017
Enrollment StartJun 20, 2018
Primary CompletionNov 12, 2021
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 8.6 years ago

Interventions

Mavenclad®drug

Participants with Relapsing Multiple Sclerosis (RMS) received Mavenclad® 3.5 milligram per kilogram (mg/kg) of body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year. Each treatment course consisted of 2 treatment weeks, one at the beginning of the first month and one at the beginning of the second month of the respective year.