A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad®
- Conditions
- MSMultiple Sclerose10012303
- Registration Number
- NL-OMON48712
- Lead Sponsor
- Merck
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
• 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
• Positive hepatitis C or hepatitis B surface antigen test and/or core antibody test for immunoglobulin G (IgG) and/or immunoglobulin M (IgM) ;•Positive for Human Immunodeficiency Virus (HIV);• 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, mitoxantrone or azathioprine, or chronic use of corticosteroids;• History of active tuberculosis, diagnosis of presence of active tuberculosis, undergoing current treatment for latent tuberculosis or latent tuberculosis ;• Presence of PML in MRI ;• Moderate or severe hepatic impairment ;• Active malignancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>synopsis:<br /><br><br /><br>Changes in MSQoL-54 at 24 months compared to baseline, i.e., the change in the<br /><br>physical and mental health composite scores. </p><br>
- Secondary Outcome Measures
Name Time Method <p>synopsis:<br /><br><br /><br>Treatment global satisfaction assessed by TSQM v1.4 at 6 months</p><br>