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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Mavenclad®
Sponsored by
Merck KGaA, Darmstadt, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple sclerosis, Mavenclad ®, Cladribine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Liverpool Hospital
  • John Hunter Hospital
  • Perron Institute - Neurology
  • The Alfred Hospital
  • Klagenfurt1
  • Paracelsus Medical University Salzburg
  • MS Clinical Trials Group
  • UB - State University of New York
  • University of Alberta
  • Montreal Neurological Hospital
  • Nemocnice Pardubickeho kraje, a.s. Pardubicka nemocnice
  • Fakultni nemocnice Brno
  • Fakultni nemocnice u sv. Anny v Brne
  • FN Hradec Kralove
  • Fakultni nemocnice v Motole
  • Helsinki University Central Hospital
  • FinnMedi Oy vastaanotto - Finn-Medi 3
  • Turku University Hospital
  • CHU de Pontchaillou
  • CHRU de Lille
  • CHU Nice - Hôpital Pasteur
  • CHU Nîmes
  • CHU Montpellier-Nîmes - Hôpital Caremeau
  • CHU de Poissy
  • Hôpital Civil
  • Universitätsklinikum Bonn
  • Universitätsklinikum Carl Gustav Carus
  • Neuro Centrum Science GmbH
  • Universitätsklinikum Essen
  • Neurologische Praxis Eppendorf
  • Medizinische Hochschule Hannover
  • Universitätsklinikum Leipzig
  • Universitätsklinikum Münster
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo
  • Barzilai Medical Center
  • Rambam MC
  • The Chaim Sheba Medical Center
  • Policlinico Universitario SS Annunziata
  • Seconda Univesità degli Studi di Napoli, AOU
  • IRCSS Neuromed Istituto Neurologico Mediterraneo
  • Universita di SIENA
  • Indywidualna Praktyka Lekarska Prof. Konrad Rejdak
  • Samodzielny Publiczny Szpital Kliniczny nr 7 SUM
  • Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanislawa Szyszko SUM w Katowicach
  • Hospital de Cruces
  • Hospital Universitario Puerta de Hierro Majadahonda
  • Hospital Clinico San Carlos
  • Hospital Vithas NISA Sevilla
  • Hospital La Fe
  • Sahlgrenska Universitetssjukhus
  • Akademiskt Specialist Centrum - Centrum för Neurologi, plan 5
  • University Hospital of Wales
  • Queen Elizabeth Hospital
  • Sheffield Teaching Hospitals Sheffield

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mavenclad®

Arm Description

Outcomes

Primary Outcome Measures

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)
CUA lesions were measured by using MRI scans.
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)
CUA lesions were measured by using MRI scans.
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)
CUA lesions were measured by using MRI scans.

Secondary Outcome Measures

Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at 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).
Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at 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).
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at 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.

Full Information

First Posted
December 1, 2017
Last Updated
February 20, 2023
Sponsor
Merck KGaA, Darmstadt, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT03364036
Brief Title
Evaluation of the Onset of Action in Highly Active MS (MAGNIFY)
Official Title
A 2-year Prospective Study to Evaluate the Onset of Action of Mavenclad® in Subjects With Highly Active Relapsing Multiple Sclerosis (MAGNIFY)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 28, 2018 (Actual)
Primary Completion Date
May 5, 2020 (Actual)
Study Completion Date
February 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck KGaA, Darmstadt, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple sclerosis, Mavenclad ®, Cladribine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mavenclad®
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Mavenclad®
Other Intervention Name(s)
Cladribine
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Description
CUA lesions were measured by using MRI scans.
Time Frame
Baseline period (the period screening to Baseline), Period 1 (Month 1-6)
Title
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)
Description
CUA lesions were measured by using MRI scans.
Time Frame
Baseline period (the period screening to Baseline), Period 2 (Month 2-6)
Title
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)
Description
CUA lesions were measured by using MRI scans.
Time Frame
Baseline period (the period screening to Baseline), Period 3 (Month 3-6)
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Description
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).
Time Frame
Baseline, Month 3, 6, 12, 15, 18 and 24
Title
Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
Description
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).
Time Frame
Baseline, Month 3, 6, 12, 15, 18 and 24
Title
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
Description
NK cell population counts are: CD16+ CD56+ NK Cells, CD16+ NK Cells, NK p46 cells, CD16lowCD56bright, and CD16brightCD56dim.
Time Frame
Baseline, Month 3, 6, 12, 15, 18 and 24.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Responsible
Organizational Affiliation
Merck KGaA, Darmstadt, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Liverpool Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
John Hunter Hospital
City
Hunter Region Mail Centre
ZIP/Postal Code
2310-2305
Country
Australia
Facility Name
Perron Institute - Neurology
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
Facility Name
The Alfred Hospital
City
Prahran
ZIP/Postal Code
3181
Country
Australia
Facility Name
Klagenfurt1
City
Klagenfurt am Wörthersee
ZIP/Postal Code
9020
Country
Austria
Facility Name
Paracelsus Medical University Salzburg
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
MS Clinical Trials Group
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z3
Country
Canada
Facility Name
UB - State University of New York
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
University of Alberta
City
Edmonton
ZIP/Postal Code
T6G 2G3
Country
Canada
Facility Name
Montreal Neurological Hospital
City
Montreal
ZIP/Postal Code
H3A 2B4
Country
Canada
Facility Name
Nemocnice Pardubickeho kraje, a.s. Pardubicka nemocnice
City
Pardubice
State/Province
Pardubický Kraj
ZIP/Postal Code
532 03
Country
Czechia
Facility Name
Fakultni nemocnice Brno
City
Brno-Bohunice
ZIP/Postal Code
630 00
Country
Czechia
Facility Name
Fakultni nemocnice u sv. Anny v Brne
City
Brno
ZIP/Postal Code
65691
Country
Czechia
Facility Name
FN Hradec Kralove
City
Chocen
ZIP/Postal Code
56501
Country
Czechia
Facility Name
Fakultni nemocnice v Motole
City
Praha 5
ZIP/Postal Code
15006
Country
Czechia
Facility Name
Helsinki University Central Hospital
City
Helsinki
Country
Finland
Facility Name
FinnMedi Oy vastaanotto - Finn-Medi 3
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20521
Country
Finland
Facility Name
CHU de Pontchaillou
City
Rennes cedex 09
State/Province
Ille Et Vilaine
ZIP/Postal Code
35033
Country
France
Facility Name
CHRU de Lille
City
Lille cedex
ZIP/Postal Code
59037
Country
France
Facility Name
CHU Nice - Hôpital Pasteur
City
NICE Cedex 1
ZIP/Postal Code
06002
Country
France
Facility Name
CHU Nîmes
City
Nimes Cedex
ZIP/Postal Code
30029
Country
France
Facility Name
CHU Montpellier-Nîmes - Hôpital Caremeau
City
Nimes
ZIP/Postal Code
30004
Country
France
Facility Name
CHU de Poissy
City
Poissy Cedex
ZIP/Postal Code
78303
Country
France
Facility Name
Hôpital Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Universitätsklinikum Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Neuro Centrum Science GmbH
City
Erbach
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
Country
Germany
Facility Name
Neurologische Praxis Eppendorf
City
Hamburg
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Munster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo
City
Szeged
ZIP/Postal Code
6701
Country
Hungary
Facility Name
Barzilai Medical Center
City
Ashkelon
ZIP/Postal Code
78306
Country
Israel
Facility Name
Rambam MC
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Tel-Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Policlinico Universitario SS Annunziata
City
Chieti
Country
Italy
Facility Name
Seconda Univesità degli Studi di Napoli, AOU
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
IRCSS Neuromed Istituto Neurologico Mediterraneo
City
Roma
ZIP/Postal Code
133
Country
Italy
Facility Name
Universita di SIENA
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Indywidualna Praktyka Lekarska Prof. Konrad Rejdak
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 7 SUM
City
Katowice
ZIP/Postal Code
40-662
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanislawa Szyszko SUM w Katowicach
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
Hospital de Cruces
City
Baracaldo Vizcaya
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Madrid
ZIP/Postal Code
28035
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Vithas NISA Sevilla
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital La Fe
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Sahlgrenska Universitetssjukhus
City
Göteborg
ZIP/Postal Code
416 85
Country
Sweden
Facility Name
Akademiskt Specialist Centrum - Centrum för Neurologi, plan 5
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
University Hospital of Wales
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XN
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Sheffield Teaching Hospitals Sheffield
City
Sheffield
ZIP/Postal Code
SI0 2JF
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
35701185
Citation
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. Erratum In: Neurol Neuroimmunol Neuroinflamm. 2022 Oct 20;9(6):
Results Reference
result
PubMed Identifier
35672923
Citation
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.
Results Reference
derived
Links:
URL
https://clinicaltrials.emdgroup.com/en/trial-details/?id=MS700568_0022
Description
Trial Awareness and Transparency website

Learn more about this trial

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

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