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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04783935




Registration number
NCT04783935
Ethics application status
Date submitted
3/03/2021
Date registered
5/03/2021

Titles & IDs
Public title
Extension to the MAGNIFY MS Trial on Mavenclad® (Magnify MS Extension)
Scientific title
A 2-year Extension Study to Evaluate Long-term Effectiveness of Mavenclad® in Participants Who Have Completed Trial MS700568_0022 (MAGNIFY MS) (Magnify MS Extension)
Secondary ID [1] 0 0
2020-003995-42
Secondary ID [2] 0 0
MS700568_0157
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®
No intervention was administered as a part of this study. Participants who had received Mavenclad® up to 2 years (Year 1 and 2) in the parent study MS700568_0022 (NCT03364036) were enrolled into this extension study and will be assessed up to 2 years follow-up (Year 3 and 4).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With No Evidence of Disease Activity (Three Parameter [NEDA-3]) During Year 3 to 4
Timepoint [1] 0 0
Year 3 to 4 after the initial dose of Mavenclad® tablets in parent study
Secondary outcome [1] 0 0
Percentage of Participants With No Evidence of Disease Activity (Three Parameter [NEDA-3]) at Year 3 and at Year 4
Timepoint [1] 0 0
At Year 3 and 4 after the initial dose of Mavenclad® tablets in parent study
Secondary outcome [2] 0 0
Percentage of Participants With No Evidence of Disease Activity (Three Parameter [NEDA-3]) After the Start of Study Medication During the Parent Study Until the End of Year 3 and Year 4
Timepoint [2] 0 0
After the initial dose of Mavenclad® tablets in parent study until the end of Year 3 and 4
Secondary outcome [3] 0 0
Percentage of Participants Remaining Three Parameter No Evidence of Disease Activity (NEDA-3) During Year 3 or 4 Among Those With NEDA-3 During Year 1 or 2
Timepoint [3] 0 0
At Year 3 and 4 after the initial dose of Mavenclad® tablets in parent study
Secondary outcome [4] 0 0
Time to First Disease Activity During Extension Study Period
Timepoint [4] 0 0
From Month 24 after the initial dose of Mavenclad tablets in parent study until the end of extension study (approximately 2 years)
Secondary outcome [5] 0 0
Time to First Disease Activity During up to Parent and Extension Study Period (4 Years)
Timepoint [5] 0 0
From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years)
Secondary outcome [6] 0 0
Time to First New or Enlarging T2 Lesion During Extension Study Period
Timepoint [6] 0 0
From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years)
Secondary outcome [7] 0 0
Time to First New T1 Gadolinium Enhancing (Gd+) Lesion During Parent and Extension Study Period
Timepoint [7] 0 0
From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years)
Secondary outcome [8] 0 0
Time to First Confirmed Disability Progression (CDP) as Measured by Expanded Disability Status Scale (EDSS) During Parent and Extension Study Period
Timepoint [8] 0 0
From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years)
Secondary outcome [9] 0 0
Time to First Qualifying Relapse During Parent and Extension Study Period
Timepoint [9] 0 0
From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years)
Secondary outcome [10] 0 0
Time to Recurrent Qualifying Relapse During Parent and Extension Study Period
Timepoint [10] 0 0
From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years)
Secondary outcome [11] 0 0
Time to Treatment Start With Other Disease Modifying Drugs (DMDs) During Parent and Extension Study Period
Timepoint [11] 0 0
From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years)
Secondary outcome [12] 0 0
Time to First New or Enlarging T2 Lesion During Extension Study Period
Timepoint [12] 0 0
From Month 24 after the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 2 years)
Secondary outcome [13] 0 0
Time to First New T1 Gadolinium Enhancing (Gd+) Lesion During Extension Study Period
Timepoint [13] 0 0
From Month 24 after the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 2 years)
Secondary outcome [14] 0 0
Time to First Confirmed Disability Progression (CDP) as Measured by Expanded Disability Status Scale (EDSS) During Extension Study Period
Timepoint [14] 0 0
From Month 24 after the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 2 years)
Secondary outcome [15] 0 0
Time to First Qualifying Relapse During Extension Study Period
Timepoint [15] 0 0
From Month 24 after the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 2 years)
Secondary outcome [16] 0 0
Time to Recurrent Qualifying Relapse During Extension Study Period
Timepoint [16] 0 0
From Month 24 after the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 2 years)
Secondary outcome [17] 0 0
Time to Treatment Start With Other Disease Modifying Drugs (DMDs) During Extension Study Period
Timepoint [17] 0 0
From Month 24 after the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 2 years)
Secondary outcome [18] 0 0
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [18] 0 0
From Month 24 after the initial dose of Mavenclad tablets in parent study until the end of extension study (approximately 2 years)

Eligibility
Key inclusion criteria
* Participants of the MAGNIFY Multiple Sclerosis (MS) trial who received at least a single dose of cladribine tablets during the MAGNIFY MS trial and data on Magnetic resonance imaging (MRI) is available/acquired from at least parent study Month 18 or Month 24 visit and Expanded Disability Status Scale (EDSS) and relapse from parent study Month 24 visit
* Capable of giving signed informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participant is considered by the Investigator, for any reason, to be an unsuitable candidate for the study
* Participation in other studies/trials

Study design
Purpose of the study
Other
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
10/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/09/2023
Sample size
Target
Accrual to date
Final
219
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 0 0
- Liverpool
Recruitment postcode(s) [2] 0 0
- New Lambton
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Klagenfurt
Country [2] 0 0
Austria
State/province [2] 0 0
Salzburg
Country [3] 0 0
Canada
State/province [3] 0 0
Edmonton
Country [4] 0 0
Canada
State/province [4] 0 0
London
Country [5] 0 0
Canada
State/province [5] 0 0
Montreal
Country [6] 0 0
Canada
State/province [6] 0 0
Vancouver
Country [7] 0 0
Czechia
State/province [7] 0 0
Brno
Country [8] 0 0
Czechia
State/province [8] 0 0
Hradec Kralove
Country [9] 0 0
Czechia
State/province [9] 0 0
Pardubice
Country [10] 0 0
Czechia
State/province [10] 0 0
Praha 5
Country [11] 0 0
Finland
State/province [11] 0 0
Tampere
Country [12] 0 0
Finland
State/province [12] 0 0
Turku
Country [13] 0 0
France
State/province [13] 0 0
Montpellier
Country [14] 0 0
France
State/province [14] 0 0
Nice
Country [15] 0 0
France
State/province [15] 0 0
Nimes
Country [16] 0 0
France
State/province [16] 0 0
Poissy Cedex
Country [17] 0 0
France
State/province [17] 0 0
Rennes Cedex 9
Country [18] 0 0
France
State/province [18] 0 0
Strasbourg Cedex
Country [19] 0 0
Germany
State/province [19] 0 0
Dresden
Country [20] 0 0
Germany
State/province [20] 0 0
Essen
Country [21] 0 0
Germany
State/province [21] 0 0
Hamburg
Country [22] 0 0
Germany
State/province [22] 0 0
Hannover
Country [23] 0 0
Germany
State/province [23] 0 0
Leipzig
Country [24] 0 0
Hungary
State/province [24] 0 0
Szeged
Country [25] 0 0
Israel
State/province [25] 0 0
Ashkelon
Country [26] 0 0
Israel
State/province [26] 0 0
Haifa
Country [27] 0 0
Israel
State/province [27] 0 0
Tel-Hashomer
Country [28] 0 0
Italy
State/province [28] 0 0
Chieti
Country [29] 0 0
Italy
State/province [29] 0 0
Napoli
Country [30] 0 0
Italy
State/province [30] 0 0
Pozzilli
Country [31] 0 0
Poland
State/province [31] 0 0
Katowice
Country [32] 0 0
Poland
State/province [32] 0 0
Lublin
Country [33] 0 0
Poland
State/province [33] 0 0
Zabrze
Country [34] 0 0
Spain
State/province [34] 0 0
Baracaldo
Country [35] 0 0
Spain
State/province [35] 0 0
Castilleja de la Cuesta
Country [36] 0 0
Spain
State/province [36] 0 0
Madrid
Country [37] 0 0
Spain
State/province [37] 0 0
Majadahonda
Country [38] 0 0
Spain
State/province [38] 0 0
Valencia
Country [39] 0 0
Sweden
State/province [39] 0 0
Göteborg
Country [40] 0 0
Sweden
State/province [40] 0 0
Stockholm
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Birmingham
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Cardiff
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of 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 Healthcare KGaA, Darmstadt, Germany, an affiliate of 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

Data sharing statement


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol
Statistical analysis plan



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04783935