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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
NA
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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

TypeCitations or Other Details
Journal de Stefano N, Barkhof F, Montalban X, Achiron A, D... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT03364036