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

Merck KGaA (EMD Serono)

Status and phase

Completed

Phase 4

Conditions

Multiple Sclerosis

Treatments

Drug: Mavenclad®

Study type

Interventional

Funder types

Industry

Identifiers

NCT03369665

MS700568_0021

2017-002632-17 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment

485 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.