A study of Mavenclad® in subjects with multiple sclerosis
Research type
Research Study
Full title
A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad®
IRAS ID
237054
Contact name
Martin Duddy
Contact email
Sponsor organisation
Merck KgaA
Eudract number
2017-002632-17
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 6 months, 0 days
Research summary
Multiple Sclerosis (MS) is a condition which can affect the brain and/or spinal cord causing a wide range of potential symptoms, including problems with vision, arm or leg movement, sensation or balance.
The study drug, Mavenclad®, has recently been approved by the European Medicines Agency (EMA) for the treatment of adults with highly active relapsing multiple sclerosis (MS).
The purpose of this study is mainly to look at the effect of Mavenclad® on quality of life by asking questions about participants' health and daily activities. Results from previous studies have shown that Mavenclad® decreases the rate of relapses and the progression of MS.
The potential benefits to participants include improvement of their condition, temporary relief of symptoms, and fewer relapses.
Individual participation in this Phase IV study is expected to last from 2 years to 2 years and 3 months.
Participants will receive Mavenclad® over a 2-week period at the beginning of each year. Participants will return to the study centre for tests including MRI scans and various clinical and neurological assessments throughout the study duration at specific visits. They will also need to provide a blood sample for required safety monitoring.
It is anticipated that approximately 445 people will participate in this open-label study. The study will be conducted in approximately 100 medical centres in Europe (including, but not limited to: Austria, Belgium, Czech Republic, Denmark, Finland, France, Greece, Hungary, Ireland, Italy, Israel, Lithuania, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, and UK) and Australia. It is anticipated that the study will last until December 2022.
This study is being funded by Merck KGaA.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
18/NE/0107
Date of REC Opinion
25 Jul 2018
REC opinion
Further Information Favourable Opinion