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

• Status: Active, not recruiting
• Trial end date: 2021-10-15
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA, Darmstadt, Germany
• Treatments: Cladribine

Criteria

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.