A Clinical Research Study for People with Relapsing Multiple Sclerosis
- Conditions
- Relapsing multiple sclerosisMedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2017-002631-42-SE
- Lead Sponsor
- Merck KGaA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 265
•Male or female subjects = 18 years old
•Highly active RMS as defined by:
-One relapse in the previous year and at least 1 T1 Gd+ lesion or 9 or more T2 lesions, while on therapy with other disease modifying drugs (DMDs)
-Two or more relapses in the previous year, whether on DMD treatment or not
•EDSS score =5.0
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 260
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 5
•Previous exposure to drugs such as fingolimod, natalizumab, alemtuzumab, mitoxantrone and ocrelizumab
•Positive test for hepatitis C or positive tests for hepatitis B infection: either hepatitis B surface antigen (HBsAg) positive, or positive hepatitis B core antibody (total anti HBcAb) confirmed by a positive viral
olymerase chain reaction (PCR)
•Current or previous history of immune deficiency disorders including a positive human immunodeficiency virus (HIV) result
•Currently receiving immunosuppressive or myelosuppressive therapy with, e.g., monoclonal antibodies, methotrexate, cyclophosphamide, cyclosporine or azathioprine, or chronic use of corticosteroids
•History of tuberculosis , presence of active tuberculosis, or latent tuberculosis
- Presence of signs of PML detected by MRI, clinical and/or biomarker evaluations
•Active malignancy
• lymphocyte count not within normal limits of the local hospital lab before initiation of first treatment course
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the onset of action of Mavenclad®in subjects with highly active relapsing multiple sclerosis (RMS).;Secondary Objective: To assess the effect of Mavenclad® on different immune system composites in particular cell subtypes count and repopulation<br>;Primary end point(s): •Differences in the counts of combined unique active (CUA) MRI lesions lesions during the first 6 months (i.e. during periods months 1-6, 2-6, 3-6) compared to baseline (i.e. the period screening to baseline)<br>;Timepoint(s) of evaluation of this end point: •At the end o 6 months compared to baseline
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •Characterization of immune cell subsets count ;Timepoint(s) of evaluation of this end point: •At the end of 3, 6, 12, 15, 18 and 24 months compared to baseline