Evaluation of the Onset of Action in Highly Active MS (MAGNIFY)
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Cladribine
DNA inhibitor
Results by group
Change From Baseline Period (Period Screening to Baseline) in Counts of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions at Period 1 (Month 1-6)
Baseline period (the period screening to Baseline), Period 1 (Month 1-6)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Experimental: Mavenclad® | -1.211 lesions | 3.4413 (Standard Deviation) | 252 |
Change From Baseline Period (Period Screening to Baseline) in Counts of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions at Period 2 (Month 2-6)
Baseline period (the period screening to Baseline), Period 2 (Month 2-6)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Experimental: Mavenclad® | -1.521 lesions | 4.0558 (Standard Deviation) | 252 |
Change From Baseline Period (Period Screening to Baseline) in Counts of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions at Period 3 (Month 3-6)
Baseline period (the period screening to Baseline), Period 3 (Month 3-6)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Experimental: Mavenclad® | -1.499 lesions | 3.4244 (Standard Deviation) | 246 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Experimental: Mavenclad® | 270 | 14 (5.2%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Change From Baseline Period (Period Screening to Baseline) in Counts of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions at Period 1 (Month 1-6)
Baseline period (the period screening to Baseline), Period 1 (Month 1-6)
MRI lesionsChange From Baseline Period (Period Screening to Baseline) in Counts of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions at Period 2 (Month 2-6)
Baseline period (the period screening to Baseline), Period 2 (Month 2-6)
MRI lesionsChange From Baseline Period (Period Screening to Baseline) in Counts of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions at Period 3 (Month 3-6)
Baseline period (the period screening to Baseline), Period 3 (Month 3-6)
MRI lesions•Differences in the counts of combined unique active (CUA) MRI lesions lesions during the first 6 months (i.e. during periods months 1-6, 2-6, 3-6) compared to baseline (i.e. the period screening to baseline)
MRI lesions
Other measures (4)
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Baseline, Month 3, 6, 12, 15, 18 and 24
Thinking and memoryImmune responsePercent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
Baseline, Month 3, 6, 12, 15, 18 and 24
Immune responsePercent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
Baseline, Month 3, 6, 12, 15, 18 and 24.
Immune response•Characterization of immune cell subsets count
Immune response
Who could take part
Relapsing MS · 18 and over
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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).
Papers
Results
Blood biomarker dynamics in people with relapsing multiple sclerosis treated with cladribine tablets: results of the 2-year MAGNIFY-MS study.Front Immunol · 2025
Results
de Stefano N, Barkhof F, Montalban X, Achiron A, Derfuss T, Chan A, Hodgkinson S, Prat A, Leocani L, Schmierer K, Sellebjerg F, Vermersch P, Wiendl H, Keller B, Roy S; MAGNIFY-MS Study Group. Early Reduction of MRI Activity During 6 Months of Treatment With Cladribine Tablets for Highly Active Relapsing Multiple Sclerosis: MAGNIFY-MS. Neurol Neuroimmunol Neuroinflamm. 2022 Jun 14;9(4):e1187. doi:Results
Schmierer K, Wiendl H, Barkhof F, Montalban X, Achiron A, Derfuss T, Chan A, Hodgkinson S, Prat A, Leocani L, Sellebjerg F, Vermersch P, Jin H, Sponton L, Chudecka A, Bucello M, Gardner L, De Stefano N. A plain language summary on clinical and mechanistic effects of cladribine in relapsing multiple sclerosis: 2-year results from the MAGNIFY-MS study. Neurodegener Dis Manag. 2026 Apr 6:1-11. doi: 1Results
Schmierer K, Wiendl H, Barkhof F, Montalban X, Achiron A, Derfuss T, Chan A, Hodgkinson S, Prat A, Leocani L, Sellebjerg F, Vermersch P, Jin H, Sponton L, Chudecka A, Gardner L, De Stefano N. Clinical and mechanistic effects of cladribine in relapsing multiple sclerosis: 2-year results from the MAGNIFY-MS Study. Ther Adv Neurol Disord. 2025 Jul 31;18:17562864251351760. doi: 10.1177/175628642513517Results
Wiendl H, Schmierer K, Hodgkinson S, Derfuss T, Chan A, Sellebjerg F, Achiron A, Montalban X, Prat A, De Stefano N, Barkhof F, Leocani L, Vermersch P, Chudecka A, Mwape C, Holmberg KH, Boschert U, Roy S; MAGNIFY-MS Study Group. Specific Patterns of Immune Cell Dynamics May Explain the Early Onset and Prolonged Efficacy of Cladribine Tablets: A MAGNIFY-MS Substudy. Neurol Neuroimmunol Neuroinflamm.Results
Schmierer K, Wiendl H, Oreja-Guevara C, Centonze D, Chudecka A, Roy S, Boschert U. Varicella zoster virus and influenza vaccine antibody titres in patients from MAGNIFY-MS who were treated with cladribine tablets for highly active relapsing multiple sclerosis. Mult Scler. 2022 Nov;28(13):2151-2153. doi: 10.1177/13524585221099413. Epub 2022 Jun 7. No abstract available.
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Linked trials
Extended by
Magnify MS ExtensionPhase 4 · Completed
Links found where a registry record names another trial's registry number.
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History
Started
May 2018
Main results due
May 2020
Finished
Feb 2022
Results posted
May 2021
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