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

NCT04783935 | Completed Phase 4 Results

• 2 other identifiers: MS700568_01572020-003995-42
• Study Type: interventional
• Target: 219
• Locations: 13 countries
• Sites: 44

Brief Summary

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).

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Mavenclad ®; Cladribine; Relapsing Multiple Sclerosis; Immune cell kinetics

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With No Evidence of Disease Activity (Three Parameter [NEDA-3]) During Year 3 to 4

  The definition of NEDA-3 encompasses a combination of the following 3 related measures of disease activity: No relapses, no confirmed disability progression sustained for 12 weeks as measured on EDSS, and no magnetic resonance imaging (MRI) disease activity, defined as no gadolinium-enhancing (GdE) lesions and no new or enlarging T2 lesions. NEDA-3 was analyzed with the Kaplan-Meier (KM) time-to-event method to reduce the impact of unknown/missing information. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. An EDSS progression was defined as an increase of the EDSS score of at least 1.5 point compared to baseline for participants with a baseline EDSS of 0. For participants with an EDSS score between 0.5 and 4.5 at baseline (SD1), EDSS progression was defined as an increase of at least 1 point. For participants with baseline EDSS score of 5, EDSS progression was defined as an increase of at least 0.5.

  Year 3 to 4 after the initial dose of Mavenclad® tablets in parent study

Secondary Outcomes (18)

• Percentage of Participants With No Evidence of Disease Activity (Three Parameter [NEDA-3]) at Year 3 and at Year 4

  At Year 3 and 4 after the initial dose of Mavenclad® tablets in parent study

• Percentage of Participants With No Evidence of Disease Activity (Three Parameter [NEDA-3]) After the Start of Study Medication During the Parent Study Until the End of Year 3 and Year 4

  After the initial dose of Mavenclad® tablets in parent study until the end of Year 3 and 4

• Percentage of Participants Remaining Three Parameter No Evidence of Disease Activity (NEDA-3) During Year 3 or 4 Among Those With NEDA-3 During Year 1 or 2

  At Year 3 and 4 after the initial dose of Mavenclad® tablets in parent study

• Time to First Disease Activity During Extension Study Period

  From Month 24 after the initial dose of Mavenclad tablets in parent study until the end of extension study (approximately 2 years)

• Time to First Disease Activity During up to Parent and Extension Study Period (4 Years)

  From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years)

Study Arms (1)

Mavenclad®

EXPERIMENTAL

Drug: Mavenclad®

Interventions

Mavenclad® 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).

Also known as: Cladribine

Mavenclad®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany: lead

Study Sites (46)

Liverpool Hospital

Liverpool, Australia

Location

John Hunter Hospital

New Lambton, Australia

Location

Klinikum Klagenfurt

Klagenfurt, Austria

Location

Paracelsus Medical University Salzburg

Salzburg, Austria

Location

University of Alberta

Edmonton, Canada

Location

Children's Hospital, London Health Sciences Centre- Pediatrics

London, Canada

Location

Montreal Neurological Hospital

Montreal, Canada

Location

MS Clinical Trials Group

Vancouver, Canada

Location

Fakultni nemocnice Brno

Brno, Czechia

Location

Fakultni nemocnice u sv. Anny v Brne

Brno, Czechia

Location

FN Hradec Kralove

Hradec Králové, Czechia

Location

Nemocnice Pardubickeho kraje, a.s. Pardubicka nemocnice

Pardubice, Czechia

Location

Fakultni nemocnice v Motole

Prague, Czechia

Location

Tampere University Hospital

Tampere, Finland

Location

Turku University Hospital

Turku, Finland

Location

CHU de Montpellier Hôpital Gui de Chauliac- Département de Neurologie

Montpellier, France

Location

CHU Nice - Hôpital Pasteur

Nice, France

Location

CHU Nîmes

Nîmes, France

Location

CHU de Poissy

Poissy, France

Location

CHU de Pontchaillou

Rennes, France

Location

Hôpital Civil

Strasbourg, France

Location

Universitätsklinikum Carl Gustav Carus

Dresden, Germany

Location

Universitätsklinikum Essen

Essen, Germany

Location

Neurologische Praxis Eppendorf

Hamburg, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

Klinik und Poliklinik fur Neurologie

Leipzig, Germany

Location

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo

Szeged, Hungary

Location

Barzilai Medical Center

Ashkelon, Israel

Location

Rambam MC

Haifa, Israel

Location

Sheba Medical Centre

Tel Litwinsky, Israel

Location

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

Chieti, Italy

Location

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

Napoli, Italy

Location

IRCSS Neuromed Istituto Neurologico Mediterraneo

Pozzilli, Italy

Location

Samodzielny Publiczny Szpital Kliniczny nr 7 SUM

Katowice, Poland

Location

Indywidualna Praktyka Lekarska Prof. Konrad Rejdak

Lublin, Poland

Location

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

Zabrze, Poland

Location

Hospital de Cruces

Barakaldo, Spain

Location

Hospital Vithas NISA Sevilla

Castilleja de la Cuesta, Spain

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Spain

Location

Hospital La Fe

Valencia, Spain

Location

Sahlgrenska Universitetssjukhus

Gothenburg, Sweden

Location

Akademiskt Specialist Centrum - Centrum för Neurologi,

Stockholm, Sweden

Location

Queen Elizabeth Hospital

Birmingham, United Kingdom

Location

University Hospital of Wales

Cardiff, United Kingdom

Location

Sheffield Teaching Hospitals Sheffield

Sheffield, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 40756532 DERIVED

Related Links

• Trial Awareness and Transparency website
• Medical Information Location Map - Med Info Contacts

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Cladribine

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

2-Chloroadenosine; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxyadenosines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Limitations and Caveats

The calculation of NEDA-3 rates for single years during the Extension Period (Year 3 and Year 4), may be limited by the sparse measurement of EDSS within each year. This may have resulted in an overestimation of the NEDA-3 rate for each year. In particular, the 6mCDP component requires a confirmatory visit. However, the majority of participants had only 1 visit during each 1-year period, which may have led to an underestimation of the number of events for this component.

Results Point of Contact

• Title: Communication Center
• Organization: Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany

service@emdgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label, single arm, exploratory, multicenter, 2-year, Phase IV extension study.

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 5, 2021
• Study Start: March 10, 2021
• Primary Completion: September 21, 2023
• Study Completion: September 21, 2023
• Last Updated: January 22, 2025
• Results First Posted: January 22, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
• Access Criteria: Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.

Locations

ES (5); PL (3); IL (3); FI (2); DE (5); IT (3); SE (2); AU (2); HU (1); GB (3); FR (6); CZ (5); CA (4)