Clinical trial NCT04783935: Extension to the MAGNIFY MS Trial on Mavenclad® (Magnify MS Extension)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Mavenclad ®
Cladribine
Relapsing Multiple Sclerosis
Immune cell kinetics
Lead sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2021-03-05
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label, single arm, exploratory, multicenter, 2-year, Phase IV extension study.
Primary purpose: OTHER

Brief summary: The primary purpose of this study was 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).


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With No Evidence of Disease Activity (Three Parameter [NEDA-3]) During Year 3 to 4
timeFrame: Year 3 to 4 after the initial dose of Mavenclad® tablets in parent study
Secondary outcomes:
measure: Percentage of Participants With No Evidence of Disease Activity (Three Parameter [NEDA-3]) at Year 3 and at Year 4
timeFrame: At Year 3 and 4 after the initial dose of Mavenclad® tablets in parent study
measure: 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
timeFrame: After the initial dose of Mavenclad® tablets in parent study until the end of Year 3 and 4
measure: 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
timeFrame: At Year 3 and 4 after the initial dose of Mavenclad® tablets in parent study
measure: Time to First Disease Activity During Extension Study Period
timeFrame: From Month 24 after the initial dose of Mavenclad tablets in parent study until the end of extension study (approximately 2 years)
measure: Time to First Disease Activity During up to Parent and Extension Study Period (4 Years)
timeFrame: From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years)
measure: Time to First New or Enlarging T2 Lesion During Extension Study Period
timeFrame: From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years)
measure: Time to First New T1 Gadolinium Enhancing (Gd+) Lesion During Parent and Extension Study Period
timeFrame: From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years)
measure: Time to First Confirmed Disability Progression (CDP) as Measured by Expanded Disability Status Scale (EDSS) During Parent and Extension Study Period
timeFrame: From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years)
measure: Time to First Qualifying Relapse During Parent and Extension Study Period
timeFrame: From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years)
measure: Time to Recurrent Qualifying Relapse During Parent and Extension Study Period
timeFrame: From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years)
measure: Time to Treatment Start With Other Disease Modifying Drugs (DMDs) During Parent and Extension Study Period
timeFrame: From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years)
measure: Time to First New or Enlarging T2 Lesion During Extension Study Period
timeFrame: From Month 24 after the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 2 years)
measure: Time to First New T1 Gadolinium Enhancing (Gd+) Lesion During Extension Study Period
timeFrame: From Month 24 after the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 2 years)
measure: Time to First Confirmed Disability Progression (CDP) as Measured by Expanded Disability Status Scale (EDSS) During Extension Study Period
timeFrame: From Month 24 after the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 2 years)
measure: Time to First Qualifying Relapse During Extension Study Period
timeFrame: From Month 24 after the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 2 years)
measure: Time to Recurrent Qualifying Relapse During Extension Study Period
timeFrame: From Month 24 after the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 2 years)
measure: Time to Treatment Start With Other Disease Modifying Drugs (DMDs) During Extension Study Period
timeFrame: From Month 24 after the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 2 years)
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From Month 24 after the initial dose of Mavenclad tablets in parent study until the end of extension study (approximately 2 years)
Other outcomes:
Locations:
city: Liverpool
country: Australia
facility: Liverpool Hospital
city: New Lambton
country: Australia
facility: John Hunter Hospital
city: Klagenfurt
country: Austria
facility: Klinikum Klagenfurt
city: Salzburg
country: Austria
facility: Paracelsus Medical University Salzburg
city: Edmonton
country: Canada
facility: University of Alberta
city: London
country: Canada
facility: Children's Hospital, London Health Sciences Centre- Pediatrics
city: Montreal
country: Canada
facility: Montreal Neurological Hospital
city: Vancouver
country: Canada
facility: MS Clinical Trials Group
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno
city: Brno
country: Czechia
facility: Fakultni nemocnice u sv. Anny v Brne
city: Hradec Kralove
country: Czechia
facility: FN Hradec Kralove
city: Pardubice
country: Czechia
facility: Nemocnice Pardubickeho kraje, a.s. Pardubicka nemocnice
city: Praha 5
country: Czechia
facility: Fakultni nemocnice v Motole
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
city: Montpellier
country: France
facility: CHU de Montpellier Hôpital Gui de Chauliac- Département de Neurologie
city: Nice
country: France
facility: CHU Nice - Hôpital Pasteur
city: Nimes
country: France
facility: CHU Nîmes
city: Poissy Cedex
country: France
facility: CHU de Poissy
city: Rennes Cedex 9
country: France
facility: CHU de Pontchaillou
city: Strasbourg Cedex
country: France
facility: Hôpital Civil
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Hamburg
country: Germany
facility: Neurologische Praxis Eppendorf
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Leipzig
country: Germany
facility: Klinik und Poliklinik fur Neurologie
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Haifa
country: Israel
facility: Rambam MC
city: Tel-Hashomer
country: Israel
facility: Sheba Medical Centre
city: Chieti
country: Italy
facility: Università "G. D'Annunzio" Chieti-Pescara Ospedale Cliniciz
city: Napoli
country: Italy
facility: Dipartimento di internistica clinica e sperimentale "Flaviano Magrassi"Università degli studi della Campania "Luigi Vanvitelli"
city: Pozzilli
country: Italy
facility: IRCSS Neuromed Istituto Neurologico Mediterraneo
city: Katowice
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 7 SUM
city: Lublin
country: Poland
facility: Indywidualna Praktyka Lekarska Prof. Konrad Rejdak
city: Zabrze
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanislawa Szyszko SUM w Katowicach
city: Baracaldo
country: Spain
facility: Hospital de Cruces
city: Castilleja de la Cuesta
country: Spain
facility: Hospital Vithas NISA Sevilla
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
city: Valencia
country: Spain
facility: Hospital La Fe
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhus
city: Stockholm
country: Sweden
facility: Akademiskt Specialist Centrum - Centrum för Neurologi,
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals Sheffield
Study officials:
affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: