Extension to the MAGNIFY MS Trial on Mavenclad® (Magnify MS Extension)

NCT ID: NCT04783935

Last Updated: 2025-01-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

219 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-10

Study Completion Date

2023-09-21

Brief Summary

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The primary purpose of this study was to evaluate the long-term effectiveness of Mavenclad® tablets, in terms of disease activity and safety, in participants with highly-active relapsing multiple sclerosis (RMS) previously participating in the MAGNIFY MS trial MS700568\_0022 (NCT03364036).

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open label, single arm, exploratory, multicenter, 2-year, Phase IV extension study.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Mavenclad®

Group Type EXPERIMENTAL

Mavenclad®

Intervention Type DRUG

No intervention was administered as a part of this study. Participants who had received Mavenclad® up to 2 years (Year 1 and 2) in the parent study MS700568\_0022 (NCT03364036) were enrolled into this extension study and will be assessed up to 2 years follow-up (Year 3 and 4).

Interventions

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Mavenclad®

No intervention was administered as a part of this study. Participants who had received Mavenclad® up to 2 years (Year 1 and 2) in the parent study MS700568\_0022 (NCT03364036) were enrolled into this extension study and will be assessed up to 2 years follow-up (Year 3 and 4).

Intervention Type DRUG

Other Intervention Names

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Cladribine

Eligibility Criteria

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Inclusion Criteria

* Participants of the MAGNIFY Multiple Sclerosis (MS) trial who received at least a single dose of cladribine tablets during the MAGNIFY MS trial and data on Magnetic resonance imaging (MRI) is available/acquired from at least parent study Month 18 or Month 24 visit and Expanded Disability Status Scale (EDSS) and relapse from parent study Month 24 visit
* Capable of giving signed informed consent

Exclusion Criteria

* Participant is considered by the Investigator, for any reason, to be an unsuitable candidate for the study
* Participation in other studies/trials
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Responsible

Role: STUDY_DIRECTOR

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Locations

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Liverpool Hospital

Liverpool, , Australia

Site Status

John Hunter Hospital

New Lambton, , Australia

Site Status

Klinikum Klagenfurt

Klagenfurt, , Austria

Site Status

Paracelsus Medical University Salzburg

Salzburg, , Austria

Site Status

University of Alberta

Edmonton, , Canada

Site Status

Children's Hospital, London Health Sciences Centre- Pediatrics

London, , Canada

Site Status

Montreal Neurological Hospital

Montreal, , Canada

Site Status

MS Clinical Trials Group

Vancouver, , Canada

Site Status

Fakultni nemocnice Brno

Brno, , Czechia

Site Status

Fakultni nemocnice u sv. Anny v Brne

Brno, , Czechia

Site Status

FN Hradec Kralove

Hradec Králové, , Czechia

Site Status

Nemocnice Pardubickeho kraje, a.s. Pardubicka nemocnice

Pardubice, , Czechia

Site Status

Fakultni nemocnice v Motole

Prague, , Czechia

Site Status

Tampere University Hospital

Tampere, , Finland

Site Status

Turku University Hospital

Turku, , Finland

Site Status

CHU de Montpellier Hôpital Gui de Chauliac- Département de Neurologie

Montpellier, , France

Site Status

CHU Nice - Hôpital Pasteur

Nice, , France

Site Status

CHU Nîmes

Nîmes, , France

Site Status

CHU de Poissy

Poissy, , France

Site Status

CHU de Pontchaillou

Rennes, , France

Site Status

Hôpital Civil

Strasbourg, , France

Site Status

Universitätsklinikum Carl Gustav Carus

Dresden, , Germany

Site Status

Universitätsklinikum Essen

Essen, , Germany

Site Status

Neurologische Praxis Eppendorf

Hamburg, , Germany

Site Status

Medizinische Hochschule Hannover

Hanover, , Germany

Site Status

Klinik und Poliklinik fur Neurologie

Leipzig, , Germany

Site Status

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo

Szeged, , Hungary

Site Status

Barzilai Medical Center

Ashkelon, , Israel

Site Status

Rambam MC

Haifa, , Israel

Site Status

Sheba Medical Centre

Tel Litwinsky, , Israel

Site Status

Università "G. D'Annunzio" Chieti-Pescara Ospedale Cliniciz

Chieti, , Italy

Site Status

Dipartimento di internistica clinica e sperimentale "Flaviano Magrassi"Università degli studi della Campania "Luigi Vanvitelli"

Napoli, , Italy

Site Status

IRCSS Neuromed Istituto Neurologico Mediterraneo

Pozzilli, , Italy

Site Status

Samodzielny Publiczny Szpital Kliniczny nr 7 SUM

Katowice, , Poland

Site Status

Indywidualna Praktyka Lekarska Prof. Konrad Rejdak

Lublin, , Poland

Site Status

Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanislawa Szyszko SUM w Katowicach

Zabrze, , Poland

Site Status

Hospital de Cruces

Barakaldo, , Spain

Site Status

Hospital Vithas NISA Sevilla

Castilleja de la Cuesta, , Spain

Site Status

Hospital Clinico San Carlos

Madrid, , Spain

Site Status

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, , Spain

Site Status

Hospital La Fe

Valencia, , Spain

Site Status

Sahlgrenska Universitetssjukhus

Gothenburg, , Sweden

Site Status

Akademiskt Specialist Centrum - Centrum för Neurologi,

Stockholm, , Sweden

Site Status

Queen Elizabeth Hospital

Birmingham, , United Kingdom

Site Status

University Hospital of Wales

Cardiff, , United Kingdom

Site Status

Sheffield Teaching Hospitals Sheffield

Sheffield, , United Kingdom

Site Status

Countries

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Australia Austria Canada Czechia Finland France Germany Hungary Israel Italy Poland Spain Sweden United Kingdom

References

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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.

Reference Type DERIVED
PMID: 40756532 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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2020-003995-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MS700568_0157

Identifier Type: -

Identifier Source: org_study_id

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