Evaluation of the Onset of Action in Highly Active MS (MAGNIFY)

Merck KGaA (EMD Serono)

Status and phase

Completed

Phase 4

Conditions

Multiple Sclerosis

Treatments

Drug: Mavenclad®

Study type

Interventional

Funder types

Industry

Identifiers

NCT03364036

MS700568_0022

2017-002631-42 (EudraCT Number)

Details and patient eligibility

About

The main purpose of the study was to determine the onset of Mavenclad® action by frequent magnetic resonance imaging (MRI) assessment of the combined unique active (CUA) lesions in participants with highly active relapsing multiple sclerosis (MS).

Enrollment

270 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

Previous exposure to drugs such as fingolimod, natalizumab, alemtuzumab, mitoxantrone and ocrelizumab.
Positive hepatitis C or hepatitis B surface antigen test and/or hepatits B 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
Evidence or suspect of Progressive Multifocal Leukoencephalopathy (PML) in Magnetic Resonance Imaging (MRI).
Active malignancy or history of malignancy.
Other protocol defined exclusion criteria could apply.