A study of Mavenclad® in participants with multiple sclerosis
Research type
Research Study
Full title
A 2-year prospective study to evaluate the onset of action of Mavenclad® in subjects with highly active relapsing multiple sclerosis
IRAS ID
236856
Contact name
Basil Sharrack
Contact email
Sponsor organisation
Merck KGaA
Eudract number
2017-002631-42
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 25 days
Research summary
Multiple Sclerosis (MS) is an immune mediated disease which affects the brain and spinal cord causing a wide range of symptoms including visual, sensory and motor impairment and difficulties with balance and sphincter control.
Mavenclad® (Cladribine) is an investigational drug that is being evaluated for the treatment of participants with highly active relapsing MS. It has recently been approved by the European Medicines Agency for the treatment of adults with highly active relapsing MS. The purpose of this study is to determine Mavenclad® onset of action. The study will also look at its clinical effectiveness , its effect on the immune system, and its potential side effects. Participants will also be given a chance to participate in any or all of the 4 sub-studies, which will collect further information on the effect of Mavenclad®.
Individual participation in the study is expected to last from 2 years to 2 years and 3 months. Participants will be expected to attend 11 visits in total: a screening visit, a baseline visit and 9 regular visits. Participants will receive Mavenclad® over a 2-week period at the beginning of each year. There is no guarantee that participants will personally gain any direct benefit from taking part in this study. The potential benefits include improvement of participant’s condition, temporary relief of symptoms and fewer relapses.
This is an open-label study. Participants will undergo various tests, including MRI scans, clinical and neurological assessments and will be asked to provide blood samples.
It is anticipated that approximately 300 people will participate in this study. The study will be conducted in approximately 100 medical centres across Europe (including the United Kingdom), as well as Israel, Australia and Canada. It is anticipated that the study will last until the first quarter of 2022.
This study is being funded by Merck KGaA.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
18/EM/0086
Date of REC Opinion
21 May 2018
REC opinion
Further Information Favourable Opinion