Extension to the MAGNIFY MS Trial on Mavenclad® (Magnify MS Extension)

Multiple Sclerosis Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04783935
• Other study ID #: MS700568_0157
• Secondary ID: 2020-003995-42
• Status: Completed
• Phase: Phase 4
• Start date: March 10, 2021
• Est. completion date: September 21, 2023

Study information

• Verified date: April 2024
• Source: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to evaluate the long-term effectiveness of Mavenclad® tablets, in terms of disease activity and safety, in participants with highly-active relapsing multiple sclerosis (RMS) previously participating in the MAGNIFY MS trial MS700568_0022 (NCT03364036).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: September 21, 2023
• Est. primary completion date: September 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

• Participant is considered by the Investigator, for any reason, to be an unsuitable candidate for the study

• Participation in other studies/trials

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
Australia	Liverpool Hospital	Liverpool
Australia	John Hunter Hospital	New Lambton
Austria	Klinikum Klagenfurt	Klagenfurt
Austria	Paracelsus Medical University Salzburg	Salzburg
Canada	University of Alberta	Edmonton
Canada	Children's Hospital, London Health Sciences Centre- Pediatrics	London
Canada	Montreal Neurological Hospital	Montreal
Canada	MS Clinical Trials Group	Vancouver
Czechia	Fakultni nemocnice Brno	Brno
Czechia	Fakultni nemocnice u sv. Anny v Brne	Brno
Czechia	FN Hradec Kralove	Hradec Kralove
Czechia	Nemocnice Pardubickeho kraje, a.s. Pardubicka nemocnice	Pardubice
Czechia	Fakultni nemocnice v Motole	Praha 5
Finland	Tampere University Hospital	Tampere
Finland	Turku University Hospital	Turku
France	CHU de Montpellier Hôpital Gui de Chauliac- Département de Neurologie	Montpellier
France	CHU Nice - Hôpital Pasteur	Nice
France	CHU Nîmes	Nimes
France	CHU de Poissy	Poissy Cedex
France	CHU de Pontchaillou	Rennes Cedex 9
France	Hôpital Civil	Strasbourg Cedex
Germany	Universitätsklinikum Carl Gustav Carus	Dresden
Germany	Universitätsklinikum Essen	Essen
Germany	Neurologische Praxis Eppendorf	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Klinik und Poliklinik fur Neurologie	Leipzig
Hungary	Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo	Szeged
Israel	Barzilai Medical Center	Ashkelon
Israel	Rambam MC	Haifa
Israel	Sheba Medical Centre	Tel-Hashomer
Italy	Università "G. D'Annunzio" Chieti-Pescara Ospedale Cliniciz	Chieti
Italy	Dipartimento di internistica clinica e sperimentale "Flaviano Magrassi"Università degli studi della Campania "Luigi Vanvitelli"	Napoli
Italy	IRCSS Neuromed Istituto Neurologico Mediterraneo	Pozzilli
Poland	Samodzielny Publiczny Szpital Kliniczny nr 7 SUM	Katowice
Poland	Indywidualna Praktyka Lekarska Prof. Konrad Rejdak	Lublin
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanislawa Szyszko SUM w Katowicach	Zabrze
Spain	Hospital de Cruces	Baracaldo
Spain	Hospital Vithas NISA Sevilla	Castilleja de la Cuesta
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario Puerta de Hierro Majadahonda	Majadahonda
Spain	Hospital La Fe	Valencia
Sweden	Sahlgrenska Universitetssjukhus	Göteborg
Sweden	Akademiskt Specialist Centrum - Centrum för Neurologi,	Stockholm
United Kingdom	Queen Elizabeth Hospital	Birmingham
United Kingdom	University Hospital of Wales	Cardiff
United Kingdom	Sheffield Teaching Hospitals Sheffield	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Countries where clinical trial is conducted

Australia,  Austria,  Canada,  Czechia,  Finland,  France,  Germany,  Hungary,  Israel,  Italy,  Poland,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with No Evidence of Disease Activity (Three Parameter [NEDA-3]) During Year 3 to 4	NEDA 3: no clinical relapse, no Magnetic Resonance Imaging (MRI) activity, no disability progression.	Year 3 to 4 after the initial dose of Mavenclad® tablets in parent study
Secondary	Percentage of Participants with No Evidence of Disease Activity (Three Parameter [NEDA-3]) at Year 3 and 4	NEDA 3: no clinical relapse, no Magnetic Resonance Imaging (MRI) activity, no disability progression.	At Year 3 and 4 after the initial dose of Mavenclad® tablets in parent study
Secondary	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	NEDA 3: no clinical relapse, no Magnetic Resonance Imaging (MRI) activity, no disability progression.	After the initial dose of Mavenclad® tablets in parent study until the end of Year 3 and 4
Secondary	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	NEDA 3: no clinical relapse, no Magnetic Resonance Imaging (MRI) activity, no disability progression.	At Year 3 and 4 after the initial dose of Mavenclad® tablets in parent study
Secondary	Time to First Disease Activity at Year 3 and 4		At Year 3 and 4 after the initial dose of Mavenclad® tablets in parent study
Secondary	Time to First Disease Activity During up to 4 Years		From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years)
Secondary	Time to First New or Enlarging T2 Lesion		From the initial dose of Mavenclad® tables in parent study until the end of extension study (approximately 4 years)
Secondary	Time to First New T1 Gadolinium Enhancing (Gd+) Lesion		From the initial dose of Mavenclad® tables in parent study until the end of extension study (approximately 4 years)
Secondary	Time to First Confirmed Disability Progression (CDP) as measured by Expanded Disability Status Scale (EDSS)		From the initial dose of Mavenclad® tables in parent study until the end of extension study (approximately 4 years)
Secondary	Time to First Qualifying Relapse		From the initial dose of Mavenclad® tables in parent study until the end of extension study (approximately 4 years)
Secondary	Time to Second Qualifying Relapse		From the initial dose of Mavenclad® tables in parent study until the end of extension study (approximately 4 years)
Secondary	Time to Treatment Start with Other Disease Modifying Drugs (DMDs)		From the initial dose of Mavenclad® tables in parent study until the end of extension study (approximately 4 years)
Secondary	Time from Extension Study Baseline to First New or Enlarging T2 Lesion		Time from Baseline (extension study), up to 2 years
Secondary	Time from Extension Study Baseline to First New T1 Gadolinium Enhancing (Gd+) Lesion		Time from Baseline (extension study), up to 2 years
Secondary	Time from Extension Study Baseline to First Confirmed Disability Progression (CDP), as measured by Expanded Disability Status Scale (EDSS)		Time from Baseline (extension study), up to 2 years
Secondary	Time from Extension Study Baseline to First Qualifying Relapse		Time from Baseline (extension study), up to 2 years
Secondary	Time from Extension Study Baseline to Second Qualifying Relapse		Time from Baseline (extension study), up to 2 years
Secondary	Time from Extension Study Baseline to Treatment Start with Other Disease Modifying Drugs (DMDs)		Time from Baseline (extension study), up to 2 years
Secondary	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)		Up to Year 3 and 4 after the initial dose of Mavenclad® tablets in parent study

External Links

•   Trial Awareness and Transparency website