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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 will be 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) will be 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 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 Onset of Action of Mavenclad® Treatment During the Parent Study until the End of Year 3 and 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 at Year 3 and 4
Timepoint [4] 0 0
At Year 3 and 4 after the initial dose of Mavenclad® tablets in parent study
Secondary outcome [5] 0 0
Time to First Disease Activity During up to 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
Timepoint [6] 0 0
From the initial dose of Mavenclad® tables 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
Timepoint [7] 0 0
From the initial dose of Mavenclad® tables 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)
Timepoint [8] 0 0
From the initial dose of Mavenclad® tables in parent study until the end of extension study (approximately 4 years)
Secondary outcome [9] 0 0
Time to First Qualifying Relapse
Timepoint [9] 0 0
From the initial dose of Mavenclad® tables in parent study until the end of extension study (approximately 4 years)
Secondary outcome [10] 0 0
Time to Second Qualifying Relapse
Timepoint [10] 0 0
From the initial dose of Mavenclad® tables 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)
Timepoint [11] 0 0
From the initial dose of Mavenclad® tables in parent study until the end of extension study (approximately 4 years)
Secondary outcome [12] 0 0
Time from Extension Study Baseline to First New or Enlarging T2 Lesion
Timepoint [12] 0 0
Time from Baseline (extension study), up to 2 years
Secondary outcome [13] 0 0
Time from Extension Study Baseline to First New T1 Gadolinium Enhancing (Gd+) Lesion
Timepoint [13] 0 0
Time from Baseline (extension study), up to 2 years
Secondary outcome [14] 0 0
Time from Extension Study Baseline to First Confirmed Disability Progression (CDP), as measured by Expanded Disability Status Scale (EDSS)
Timepoint [14] 0 0
Time from Baseline (extension study), up to 2 years
Secondary outcome [15] 0 0
Time from Extension Study Baseline to First Qualifying Relapse
Timepoint [15] 0 0
Time from Baseline (extension study), up to 2 years
Secondary outcome [16] 0 0
Time from Extension Study Baseline to Second Qualifying Relapse
Timepoint [16] 0 0
Time from Baseline (extension study), up to 2 years
Secondary outcome [17] 0 0
Time from Extension Study Baseline to Treatment Start with Other Disease Modifying Drugs (DMDs)
Timepoint [17] 0 0
Time from Baseline (extension study), up to 2 years
Secondary outcome [18] 0 0
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [18] 0 0
Up to Year 3 and 4 after the initial dose of Mavenclad® tablets in parent study

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
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
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
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
Available to whom?
Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://bit.ly/IPD21


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04783935