Evaluation of the Onset of Action in Highly Active MS (MAGNIFY)
- Registration Number
- NCT03364036
- Lead Sponsor
- Merck KGaA, Darmstadt, Germany
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 270
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Mavenclad® Mavenclad® -
- Primary Outcome Measures
Name Time Method 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) Baseline period (the period screening to Baseline), Period 3 (Month 3-6) 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) Baseline period (the period screening to Baseline), 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 1 (Month 1-6) Baseline period (the period screening to Baseline), Period 1 (Month 1-6) CUA lesions were measured by using MRI scans.
- Secondary Outcome Measures
Name Time Method Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24 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).
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24 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).
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24 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.
Trial Locations
- Locations (54)
Liverpool Hospital
🇦🇺Sydney, New South Wales, Australia
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo
🇭🇺Szeged, Hungary
Rambam MC
🇮🇱Haifa, Israel
Klagenfurt1
🇦🇹Klagenfurt am Wörthersee, Austria
University Hospital of Wales
🇬🇧Cardiff, Wales, United Kingdom
MS Clinical Trials Group
🇨🇦Vancouver, British Columbia, Canada
Barzilai Medical Center
🇮🇱Ashkelon, Israel
Helsinki University Central Hospital
🇫🇮Helsinki, Finland
FinnMedi Oy vastaanotto - Finn-Medi 3
🇫🇮Tampere, Finland
John Hunter Hospital
🇦🇺Hunter Region Mail Centre, Australia
Perron Institute - Neurology
🇦🇺Nedlands, Australia
The Alfred Hospital
🇦🇺Prahran, Australia
Nemocnice Pardubickeho kraje, a.s. Pardubicka nemocnice
🇨🇿Pardubice, Pardubický Kraj, Czechia
University of Alberta
🇨🇦Edmonton, Canada
Montreal Neurological Hospital
🇨🇦Montreal, Canada
UB - State University of New York
🇨🇦London, Ontario, Canada
Fakultni nemocnice Brno
🇨🇿Brno-Bohunice, Czechia
FN Hradec Kralove
🇨🇿Chocen, Czechia
Fakultni nemocnice v Motole
🇨🇿Praha 5, Czechia
Turku University Hospital
🇫🇮Turku, Finland
CHRU de Lille
🇫🇷Lille cedex, France
CHU Montpellier-Nîmes - Hôpital Caremeau
🇫🇷Nimes, France
CHU Nice - Hôpital Pasteur
🇫🇷NICE Cedex 1, France
CHU Nîmes
🇫🇷Nimes Cedex, France
Universitätsklinikum Essen
🇩🇪Essen, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Universitätsklinikum Bonn
🇩🇪Bonn, Germany
Neuro Centrum Science GmbH
🇩🇪Erbach, Germany
Neurologische Praxis Eppendorf
🇩🇪Hamburg, Germany
Seconda Univesità degli Studi di Napoli, AOU
🇮🇹Napoli, Italy
Universitätsklinikum Leipzig
🇩🇪Leipzig, Germany
Universitätsklinikum Münster
🇩🇪Munster, Germany
Policlinico Universitario SS Annunziata
🇮🇹Chieti, Italy
IRCSS Neuromed Istituto Neurologico Mediterraneo
🇮🇹Roma, Italy
The Chaim Sheba Medical Center
🇮🇱Tel-Hashomer, Israel
Universita di SIENA
🇮🇹Siena, Italy
Indywidualna Praktyka Lekarska Prof. Konrad Rejdak
🇵🇱Lublin, Lubelskie, Poland
Samodzielny Publiczny Szpital Kliniczny nr 7 SUM
🇵🇱Katowice, Poland
Hospital de Cruces
🇪🇸Baracaldo Vizcaya, Vizcaya, Spain
Hospital Universitario Puerta de Hierro Majadahonda
🇪🇸Madrid, Spain
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanislawa Szyszko SUM w Katowicach
🇵🇱Zabrze, Poland
Akademiskt Specialist Centrum - Centrum för Neurologi, plan 5
🇸🇪Stockholm, Sweden
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Sahlgrenska Universitetssjukhus
🇸🇪Göteborg, Sweden
Hospital Vithas NISA Sevilla
🇪🇸Sevilla, Spain
Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
Sheffield Teaching Hospitals Sheffield
🇬🇧Sheffield, United Kingdom
Paracelsus Medical University Salzburg
🇦🇹Salzburg, Austria
Fakultni nemocnice u sv. Anny v Brne
🇨🇿Brno, Czechia
CHU de Pontchaillou
🇫🇷Rennes cedex 09, Ille Et Vilaine, France
Hôpital Civil
🇫🇷Strasbourg, France
CHU de Poissy
🇫🇷Poissy Cedex, France
Universitätsklinikum Carl Gustav Carus
🇩🇪Dresden, Germany
Hospital La Fe
🇪🇸Valencia, Spain