Evaluation of the Onset of Action in Highly Active MS (MAGNIFY)
NCT ID: NCT03364036
Last Updated: 2023-03-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
270 participants
INTERVENTIONAL
2018-05-28
2022-02-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Mavenclad®
Mavenclad®
Participants received Mavenclad® 3.5 milligram per kilogram (mg/kg) of body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year.
Interventions
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Mavenclad®
Participants received Mavenclad® 3.5 milligram per kilogram (mg/kg) of body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
Merck KGaA, Darmstadt, Germany
Locations
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Liverpool Hospital
Sydney, New South Wales, Australia
John Hunter Hospital
Hunter Region Mail Centre, , Australia
Perron Institute - Neurology
Nedlands, , Australia
The Alfred Hospital
Prahran, , Australia
Klagenfurt1
Klagenfurt, , Austria
Paracelsus Medical University Salzburg
Salzburg, , Austria
MS Clinical Trials Group
Vancouver, British Columbia, Canada
UB - State University of New York
London, Ontario, Canada
University of Alberta
Edmonton, , Canada
Montreal Neurological Hospital
Montreal, , Canada
Fakultni nemocnice Brno
Brno-Bohunice, Brno-Bohunice, Czechia
Nemocnice Pardubickeho kraje, a.s. Pardubicka nemocnice
Pardubice, Pardubický kraj, Czechia
Fakultni nemocnice u sv. Anny v Brne
Brno, , Czechia
FN Hradec Kralove
Choceň, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
Helsinki University Central Hospital
Helsinki, , Finland
FinnMedi Oy vastaanotto - Finn-Medi 3
Tampere, , Finland
Turku University Hospital
Turku, , Finland
CHU de Pontchaillou
Rennes, Ille Et Vilaine, France
CHRU de Lille
Lille, , France
CHU Nice - Hôpital Pasteur
Nice, , France
CHU Montpellier-Nîmes - Hôpital Caremeau
Nîmes, , France
CHU Nîmes
Nîmes, , France
CHU de Poissy
Poissy, , France
Hôpital Civil
Strasbourg, , France
Universitätsklinikum Bonn
Bonn, , Germany
Universitätsklinikum Carl Gustav Carus
Dresden, , Germany
Neuro Centrum Science GmbH
Erbach im Odenwald, , Germany
Universitätsklinikum Essen
Essen, , Germany
Neurologische Praxis Eppendorf
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitätsklinikum Leipzig
Leipzig, , Germany
Universitätsklinikum Münster
Münster, , Germany
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo
Szeged, , Hungary
Barzilai Medical Center
Ashkelon, , Israel
Rambam MC
Haifa, , Israel
The Chaim Sheba Medical Center
Tel Litwinsky, , Israel
Policlinico Universitario SS Annunziata
Chieti, , Italy
Seconda Univesità degli Studi di Napoli, AOU
Napoli, , Italy
IRCSS Neuromed Istituto Neurologico Mediterraneo
Roma, , Italy
Universita di SIENA
Siena, , Italy
Indywidualna Praktyka Lekarska Prof. Konrad Rejdak
Lublin, Lublin Voivodeship, Poland
Samodzielny Publiczny Szpital Kliniczny nr 7 SUM
Katowice, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanislawa Szyszko SUM w Katowicach
Zabrze, , Poland
Hospital de Cruces
Baracaldo Vizcaya, Vizcaya, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Vithas NISA Sevilla
Seville, , Spain
Hospital La Fe
Valencia, , Spain
Sahlgrenska Universitetssjukhus
Gothenburg, , Sweden
Akademiskt Specialist Centrum - Centrum för Neurologi, plan 5
Stockholm, , Sweden
University Hospital of Wales
Cardiff, Wales, United Kingdom
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Sheffield Teaching Hospitals Sheffield
Sheffield, , United Kingdom
Countries
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References
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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: 10.1212/NXI.0000000000001187. Print 2022 Jul.
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: 10.1177/17562864251351760. eCollection 2025.
Wiendl H, Barkhof F, Montalban X, Achiron A, Derfuss T, Chan A, Hodgkinson S, Prat A, Leocani L, Schmierer K, Sellebjerg F, Vermersch P, Jin H, Chudecka A, Kloetgen A, Lin D, Gardner L, De Stefano N. Blood biomarker dynamics in people with relapsing multiple sclerosis treated with cladribine tablets: results of the 2-year MAGNIFY-MS study. Front Immunol. 2025 Feb 3;16:1512189. doi: 10.3389/fimmu.2025.1512189. eCollection 2025.
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. 2022 Nov 21;10(1):e200048. doi: 10.1212/NXI.0000000000200048. Print 2023 Jan.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Trial Awareness and Transparency website
Medical Information Location Map - Med Info Contacts
Other Identifiers
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2017-002631-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MS700568_0022
Identifier Type: -
Identifier Source: org_study_id
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