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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03364036




Registration number
NCT03364036
Ethics application status
Date submitted
1/12/2017
Date registered
6/12/2017
Date last updated
16/03/2023

Titles & IDs
Public title
Evaluation of the Onset of Action in Highly Active MS (MAGNIFY)
Scientific title
A 2-year Prospective Study to Evaluate the Onset of Action of Mavenclad® in Subjects With Highly Active Relapsing Multiple Sclerosis (MAGNIFY)
Secondary ID [1] 0 0
2017-002631-42
Secondary ID [2] 0 0
MS700568_0022
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Mavenclad®

Experimental: Mavenclad® -


Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
Baseline period (the period screening to Baseline), Period 1 (Month 1-6)
Primary outcome [2] 0 0
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)
Timepoint [2] 0 0
Baseline period (the period screening to Baseline), Period 2 (Month 2-6)
Primary outcome [3] 0 0
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)
Timepoint [3] 0 0
Baseline period (the period screening to Baseline), Period 3 (Month 3-6)
Secondary outcome [1] 0 0
Percent Change From Baseline in Counts of Immune Cell Subsets - B Cells at Month 3, 6, 12, 15, 18 and 24
Timepoint [1] 0 0
Baseline, Month 3, 6, 12, 15, 18 and 24
Secondary outcome [2] 0 0
Percent Change From Baseline in Counts of Immune Cell Subsets - T Cells at Month 3, 6, 12, 15, 18 and 24
Timepoint [2] 0 0
Baseline, Month 3, 6, 12, 15, 18 and 24
Secondary outcome [3] 0 0
Percent Change From Baseline in Counts of Immune Cell Subsets - NK Cells at Month 3, 6, 12, 15, 18 and 24
Timepoint [3] 0 0
Baseline, Month 3, 6, 12, 15, 18 and 24.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/05/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/02/2022
Sample size
Target
Accrual to date
Final
270
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Liverpool Hospital - Sydney
Recruitment hospital [2] 0 0
John Hunter Hospital - Hunter Region Mail Centre
Recruitment hospital [3] 0 0
Perron Institute - Neurology - Nedlands
Recruitment hospital [4] 0 0
The Alfred Hospital - Prahran
Recruitment postcode(s) [1] 0 0
2170 - Sydney
Recruitment postcode(s) [2] 0 0
2310-2305 - Hunter Region Mail Centre
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment postcode(s) [4] 0 0
3181 - Prahran
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Klagenfurt am Wörthersee
Country [2] 0 0
Austria
State/province [2] 0 0
Salzburg
Country [3] 0 0
Canada
State/province [3] 0 0
British Columbia
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
Canada
State/province [5] 0 0
Edmonton
Country [6] 0 0
Canada
State/province [6] 0 0
Montreal
Country [7] 0 0
Czechia
State/province [7] 0 0
Pardubický Kraj
Country [8] 0 0
Czechia
State/province [8] 0 0
Brno-Bohunice
Country [9] 0 0
Czechia
State/province [9] 0 0
Brno
Country [10] 0 0
Czechia
State/province [10] 0 0
Chocen
Country [11] 0 0
Czechia
State/province [11] 0 0
Praha 5
Country [12] 0 0
Finland
State/province [12] 0 0
Helsinki
Country [13] 0 0
Finland
State/province [13] 0 0
Tampere
Country [14] 0 0
Finland
State/province [14] 0 0
Turku
Country [15] 0 0
France
State/province [15] 0 0
Ille Et Vilaine
Country [16] 0 0
France
State/province [16] 0 0
Lille cedex
Country [17] 0 0
France
State/province [17] 0 0
NICE Cedex 1
Country [18] 0 0
France
State/province [18] 0 0
Nimes Cedex
Country [19] 0 0
France
State/province [19] 0 0
Nimes
Country [20] 0 0
France
State/province [20] 0 0
Poissy Cedex
Country [21] 0 0
France
State/province [21] 0 0
Strasbourg
Country [22] 0 0
Germany
State/province [22] 0 0
Bonn
Country [23] 0 0
Germany
State/province [23] 0 0
Dresden
Country [24] 0 0
Germany
State/province [24] 0 0
Erbach
Country [25] 0 0
Germany
State/province [25] 0 0
Essen
Country [26] 0 0
Germany
State/province [26] 0 0
Hamburg
Country [27] 0 0
Germany
State/province [27] 0 0
Hannover
Country [28] 0 0
Germany
State/province [28] 0 0
Leipzig
Country [29] 0 0
Germany
State/province [29] 0 0
Munster
Country [30] 0 0
Hungary
State/province [30] 0 0
Szeged
Country [31] 0 0
Israel
State/province [31] 0 0
Ashkelon
Country [32] 0 0
Israel
State/province [32] 0 0
Haifa
Country [33] 0 0
Israel
State/province [33] 0 0
Tel-Hashomer
Country [34] 0 0
Italy
State/province [34] 0 0
Chieti
Country [35] 0 0
Italy
State/province [35] 0 0
Napoli
Country [36] 0 0
Italy
State/province [36] 0 0
Roma
Country [37] 0 0
Italy
State/province [37] 0 0
Siena
Country [38] 0 0
Poland
State/province [38] 0 0
Lubelskie
Country [39] 0 0
Poland
State/province [39] 0 0
Katowice
Country [40] 0 0
Poland
State/province [40] 0 0
Zabrze
Country [41] 0 0
Spain
State/province [41] 0 0
Vizcaya
Country [42] 0 0
Spain
State/province [42] 0 0
Madrid
Country [43] 0 0
Spain
State/province [43] 0 0
Sevilla
Country [44] 0 0
Spain
State/province [44] 0 0
Valencia
Country [45] 0 0
Sweden
State/province [45] 0 0
Göteborg
Country [46] 0 0
Sweden
State/province [46] 0 0
Stockholm
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Wales
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Birmingham
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck KGaA, Darmstadt, Germany
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT03364036
Trial related presentations / publications
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):e200061. doi: 10.1212/NXI.0000000000200061.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Medical Responsible
Address 0 0
Merck KGaA, Darmstadt, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03364036