Evaluation of the Onset of Action in Highly Active MS (MAGNIFY)

February 20, 2023 updated by: Merck KGaA, Darmstadt, Germany

A 2-year Prospective Study to Evaluate the Onset of Action of Mavenclad® in Subjects With Highly Active Relapsing Multiple Sclerosis (MAGNIFY)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

270

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Hunter Region Mail Centre, Australia, 2310-2305
        • John Hunter Hospital
      • Nedlands, Australia, 6009
        • Perron Institute - Neurology
      • Prahran, Australia, 3181
        • The Alfred Hospital
    • New South Wales
      • Sydney, New South Wales, Australia, 2170
        • Liverpool Hospital
  • Austria
      • Klagenfurt am Wörthersee, Austria, 9020
        • Klagenfurt1
      • Salzburg, Austria, 5020
        • Paracelsus Medical University Salzburg
  • Canada
      • Edmonton, Canada, T6G 2G3
        • University of Alberta
      • Montreal, Canada, H3A 2B4
        • Montreal Neurological Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 1Z3
        • MS Clinical Trials Group
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • UB - State University of New York
  • Czechia
      • Brno, Czechia, 65691
        • Fakultni nemocnice u sv. Anny v Brne
      • Brno-Bohunice, Czechia, 630 00
        • Fakultni nemocnice Brno
      • Chocen, Czechia, 56501
        • FN Hradec Kralove
      • Praha 5, Czechia, 15006
        • Fakultni nemocnice v Motole
    • Pardubický Kraj
      • Pardubice, Pardubický Kraj, Czechia, 532 03
        • Nemocnice Pardubickeho kraje, a.s. Pardubicka nemocnice
  • Finland
      • Helsinki, Finland
        • Helsinki University Central Hospital
      • Tampere, Finland, 33520
        • FinnMedi Oy vastaanotto - Finn-Medi 3
      • Turku, Finland, 20521
        • Turku University Hospital
  • France
      • Lille cedex, France, 59037
        • CHRU de Lille
      • NICE Cedex 1, France, 06002
        • CHU Nice - Hôpital Pasteur
      • Nimes, France, 30004
        • CHU Montpellier-Nîmes - Hôpital Caremeau
      • Nimes Cedex, France, 30029
        • CHU Nîmes
      • Poissy Cedex, France, 78303
        • CHU de Poissy
      • Strasbourg, France, 67091
        • Hôpital Civil
    • Ille Et Vilaine
      • Rennes cedex 09, Ille Et Vilaine, France, 35033
        • CHU de Pontchaillou
  • Germany
      • Bonn, Germany, 53105
        • Universitatsklinikum Bonn
      • Dresden, Germany, 01307
        • Universitätsklinikum Carl Gustav Carus
      • Erbach, Germany
        • Neuro Centrum Science GmbH
      • Essen, Germany
        • Universitatsklinikum Essen
      • Hamburg, Germany
        • Neurologische Praxis Eppendorf
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Leipzig, Germany, 04103
        • Universitätsklinikum Leipzig
      • Munster, Germany, 48149
        • Universitatsklinikum Munster
  • Hungary
      • Szeged, Hungary, 6701
        • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo
  • Israel
      • Ashkelon, Israel, 78306
        • Barzilai Medical Center
      • Haifa, Israel, 31096
        • Rambam MC
      • Tel-Hashomer, Israel, 52621
        • The Chaim Sheba Medical Center
  • Italy
      • Chieti, Italy
        • Policlinico Universitario SS Annunziata
      • Napoli, Italy, 80131
        • Seconda Univesità degli Studi di Napoli, AOU
      • Roma, Italy, 133
        • IRCSS Neuromed Istituto Neurologico Mediterraneo
      • Siena, Italy, 53100
        • Universita di SIENA
  • Poland
      • Katowice, Poland, 40-662
        • Samodzielny Publiczny Szpital Kliniczny nr 7 SUM
      • Zabrze, Poland, 41-800
        • Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanislawa Szyszko SUM w Katowicach
    • Lubelskie
      • Lublin, Lubelskie, Poland, 20-954
        • Indywidualna Praktyka Lekarska Prof. Konrad Rejdak
  • Spain
      • Madrid, Spain, 28035
        • Hospital Universitario Puerta de Hierro Majadahonda
      • Madrid, Spain, 28046
        • Hospital Clínico San Carlos
      • Sevilla, Spain, 41009
        • Hospital Vithas NISA Sevilla
      • Valencia, Spain, 46009
        • Hospital La Fe
    • Vizcaya
      • Baracaldo Vizcaya, Vizcaya, Spain, 48903
        • Hospital de Cruces
  • Sweden
      • Göteborg, Sweden, 416 85
        • Sahlgrenska Universitetssjukhus
      • Stockholm, Sweden, 171 76
        • Akademiskt Specialist Centrum - Centrum för Neurologi, plan 5
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Queen Elizabeth Hospital
      • Sheffield, United Kingdom, SI0 2JF
        • Sheffield Teaching Hospitals Sheffield
    • Wales
      • Cardiff, Wales, United Kingdom, CF14 4XN
        • University Hospital of Wales

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mavenclad®
Drug: 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 Names:
  • Cladribine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: Baseline period (the period screening to Baseline), Period 3 (Month 3-6)
CUA lesions were measured by using MRI scans.
Baseline period (the period screening to Baseline), Period 3 (Month 3-6)
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)
Time Frame: Baseline period (the period screening to Baseline), Period 2 (Month 2-6)
CUA lesions were measured by using MRI scans.
Baseline period (the period screening to Baseline), Period 2 (Month 2-6)
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)
Time Frame: Baseline period (the period screening to Baseline), Period 1 (Month 1-6)
CUA lesions were measured by using MRI scans.
Baseline period (the period screening to Baseline), Period 1 (Month 1-6)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Time Frame: Baseline, Month 3, 6, 12, 15, 18 and 24
B cell population counts are: CD19 B cells (TBNK panel), CD20 B cells (B cell panel), Memory B cells (B cell panel), Activated B cells (B cell panel), Total plasma cells (B cell panel), Short-lived plasma cells (B cell panel), Naïve B cells (B cell panel), Transitional B cells (B cell panel), and Regulatory B cells (B cell panel).
Baseline, Month 3, 6, 12, 15, 18 and 24
Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
Time Frame: Baseline, Month 3, 6, 12, 15, 18 and 24
T cell population counts are: Total CD4 T cells (TBNK panel), CD4 Th1 cells (T cell panel), CD4 Th17 T cells (T cell panel), CD4 Regulatory T cells (T cell panel), and Total CD8 T cells (TBNK panel).
Baseline, Month 3, 6, 12, 15, 18 and 24
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
Time Frame: Baseline, Month 3, 6, 12, 15, 18 and 24.
NK cell population counts are: CD16+ CD56+ NK Cells, CD16+ NK Cells, NK p46 cells, CD16lowCD56bright, and CD16brightCD56dim.
Baseline, Month 3, 6, 12, 15, 18 and 24.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2018

Primary Completion (Actual)

May 5, 2020

Study Completion (Actual)

February 21, 2022

Study Registration Dates

First Submitted

December 1, 2017

First Submitted That Met QC Criteria

December 1, 2017

First Posted (Actual)

December 6, 2017

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

February 20, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS700568_0022
  • 2017-002631-42 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Sclerosis

Clinical Trials on Mavenclad®

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe