A Quality of Life 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
- EUCTR2017-002632-17-ES
- Lead Sponsor
- Merck KGaA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 445
• 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 445
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Positive hepatitis C or hepatitis B surface antigen test and/or core
antibody test for immunoglobulin G (IgG) and/or immunoglobulin M
(IgM)
• 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 PML in MRI
• Active malignancy and history of malignancy
• Hypersensitivity to Mavenclad® or to any of the excipients listed in the
SmPC
• Presence or suspect of PML or other (than MS) major Central Nervous
System disease clinically diagnosed or evidences in screening MRI
• Moderate or severe renal impairment (creatinine clearance <60
mL/min)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the health related quality of life (HRQoL) through the MSQOL-54 scale in relapsing multiple sclerosis subjects treated with Mavenclad® for 2 years (24 months);Secondary Objective: To assess treatment satisfaction through the TSQM v1.4 questionnaire in relapsing multiple sclerosis subjects at 6 months of treatment;Primary end point(s): Changes in MSQoL-54 at 24 months compared to baseline;Timepoint(s) of evaluation of this end point: at 24 months compared to baseline
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Treatment satisfaction assessed by TSQM v1.4 at 6 months;Timepoint(s) of evaluation of this end point: at 6 months