Evaluation of Quality of Life (QoL) in Subjects With Highly Active Relapsing Multiple Sclerosis (MS) (CLARIFY MS)

Treatment tested

• Cladribine

  DNA inhibitor

Other measures (2)

Inclusion Criteria: * 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. * Expanded Disability Status Scale (EDSS) score less than equals to (\<=) 5.0. * Other protocol defined inclusion criteria could apply. Exclusion Criteria: * 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, for example, monoclonal antibodies, methotrexate, cyclophosphamide, cyclosporine or azathioprine, or chronic use of corticosteroids. * History of tuberculosis, presence of active tuberculosis, or latent tuberculosis * Presence of Progressive Multifocal Leukoencephalopathy (PML) in Magnetic Resonance Imaging (MRI). * Active malignancy. * Other protocol defined exclusion criteria could apply.

The main purpose of the study was to assess the health-related quality of life (HRQoL) through the Multiple Sclerosis Quality of Life-54 Questionnaire (MSQoL-54) scale in highly-active relapsing multiple sclerosis (RMS) particpants treated with Mavenclad® for 2 years (24 months).