Status:
COMPLETED
Evaluation of the Onset of Action in Highly Active MS (MAGNIFY)
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 h...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2022
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT03364036
Start Date
May 28 2018
End Date
February 21 2022
Last Update
March 16 2023
Active Locations (54)
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1
Liverpool Hospital
Sydney, New South Wales, Australia, 2170
2
John Hunter Hospital
Hunter Region Mail Centre, Australia, 2310-2305
3
Perron Institute - Neurology
Nedlands, Australia, 6009
4
The Alfred Hospital
Prahran, Australia, 3181