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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03364036
Ethics application status
Date submitted
1/12/2017
Date registered
6/12/2017
Date last updated
18/07/2019

Titles & IDs
Public title
Evaluation of the Onset of Action in Highly Active Multiple Sclerosis (MS)
Scientific title
A 2-year Prospective Study to Evaluate the Onset of Action of Mavenclad® in Subjects With Highly Active Relapsing Multiple Sclerosis
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®
Subjects will receive 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 in Counts of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions at Month 6
Timepoint [1] 0 0
Baseline, Month 6
Secondary outcome [1] 0 0
Change From Baseline in Counts of Immune Cell Subsets at Month 3, 6, 12, 15, 18 and 24 - Immune cell subsets will be analyzed by flow cytometry analysis.
Timepoint [1] 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
Gender
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
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Liverpool Hospital - Sydney
Recruitment hospital [3] 0 0
John Hunter Hospital (8284) - Hunter Region Mail Centre
Recruitment hospital [4] 0 0
Perron Institute - Neurology - Nedlands
Recruitment hospital [5] 0 0
The Alfred Hospital (12718) - Prahran
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2170 - Sydney
Recruitment postcode(s) [3] 0 0
2310-2305 - Hunter Region Mail Centre
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment postcode(s) [5] 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
Belgium
State/province [3] 0 0
Diepenbeek
Country [4] 0 0
Belgium
State/province [4] 0 0
Liège
Country [5] 0 0
Canada
State/province [5] 0 0
British Columbia
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Canada
State/province [7] 0 0
Edmonton
Country [8] 0 0
Canada
State/province [8] 0 0
Montreal
Country [9] 0 0
Canada
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Toronto
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Czechia
State/province [10] 0 0
Pardubický Kraj
Country [11] 0 0
Czechia
State/province [11] 0 0
Brno-Bohunice
Country [12] 0 0
Czechia
State/province [12] 0 0
Brno
Country [13] 0 0
Czechia
State/province [13] 0 0
Chocen
Country [14] 0 0
Czechia
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Praha 2
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Czechia
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Praha 5
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Finland
State/province [16] 0 0
Helsinki
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Finland
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Tampere
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Finland
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Turku
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France
State/province [19] 0 0
Ille Et Vilaine
Country [20] 0 0
France
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Bron
Country [21] 0 0
France
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Marseille Cedex 05
Country [22] 0 0
France
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NICE Cedex 1
Country [23] 0 0
France
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Nimes Cedex
Country [24] 0 0
France
State/province [24] 0 0
Nimes
Country [25] 0 0
France
State/province [25] 0 0
Strasbourg
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France
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Toulouse
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Germany
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Berlin
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Germany
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Bonn
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Germany
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Dresden
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Germany
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Erbach
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Germany
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Essen
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Germany
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Hamburg
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Germany
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Hannover
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Germany
State/province [34] 0 0
Heidelberg
Country [35] 0 0
Germany
State/province [35] 0 0
Leipzig
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Germany
State/province [36] 0 0
Munster
Country [37] 0 0
Germany
State/province [37] 0 0
Ulm
Country [38] 0 0
Hungary
State/province [38] 0 0
Szeged
Country [39] 0 0
Israel
State/province [39] 0 0
Ashkelon
Country [40] 0 0
Israel
State/province [40] 0 0
Haifa
Country [41] 0 0
Israel
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Jerusalem
Country [42] 0 0
Israel
State/province [42] 0 0
Petah Tikva
Country [43] 0 0
Israel
State/province [43] 0 0
Tel-Hashomer
Country [44] 0 0
Italy
State/province [44] 0 0
Chieti
Country [45] 0 0
Italy
State/province [45] 0 0
Milano
Country [46] 0 0
Italy
State/province [46] 0 0
Napoli
Country [47] 0 0
Italy
State/province [47] 0 0
Roma
Country [48] 0 0
Italy
State/province [48] 0 0
Siena
Country [49] 0 0
Poland
State/province [49] 0 0
Lubelskie
Country [50] 0 0
Poland
State/province [50] 0 0
Katowice
Country [51] 0 0
Poland
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Zabrze
Country [52] 0 0
Spain
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Vizcaya
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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Valencia
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Sweden
State/province [56] 0 0
Göteborg
Country [57] 0 0
Sweden
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Stockholm
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Wales
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Birmingham
Country [60] 0 0
United Kingdom
State/province [60] 0 0
London
Country [61] 0 0
United Kingdom
State/province [61] 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 is to determine the onset of Mavenclad® action by frequent
magnetic resonance imaging (MRI) assessment of the combined unique active (CUA) lesions in
subjects with highly active relapsing multiple sclerosis (RMS).
Trial website
https://clinicaltrials.gov/show/NCT03364036
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

Summary results
Other publications