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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
270

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Universitatsklinikum Carl Gustav Carus
      • Erbach, Germany
        • Neuro Centrum Science GmbH
      • Essen, Germany
        • Universitätsklinikum Essen
      • Hamburg, Germany
        • Neurologische Praxis Eppendorf
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Leipzig, Germany, 04103
        • Universitatsklinikum Leipzig
      • Munster, Germany, 48149
        • Universitätsklinikum Münster
  • 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
        • Università 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 Clinico 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 28, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 5, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 21, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings