A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad®

Merck KGaA0 sites445 target enrollmentJanuary 29, 2018

Overview

No summary available.

Registry

who.int

Start Date

January 29, 2018

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Male or female subjects \= 18 years old;
•Highly active RMS as defined by:
•\- One relapse in the previous year and at least 1 T1 Gadolinium (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

•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
•polymerase 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, mitoxanthrone or azathioprine), or chronic use of corticosteroids
•History of tuberculosis, presence of active tuberculosis, or latent tuberculosis
•Presence of signs of progressive multifocal leukoencephalopathy
•(PML) detected by MRI, clinical and/or biomarker evaluations or other
•(than MS) major Central Nervous System disease clinically diagnosed or
•evidenced in screening MRI
•Active malignancy and history of malignancy