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

Primary Purpose

Multiple Sclerosis

Status
Active
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Mavenclad®
Sponsored by
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Mavenclad ®, Cladribine, Relapsing Multiple Sclerosis, Immune cell kinetics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Liverpool Hospital
  • John Hunter Hospital
  • Klinikum Klagenfurt
  • Paracelsus Medical University Salzburg
  • University of Alberta
  • Children's Hospital, London Health Sciences Centre- Pediatrics
  • Montreal Neurological Hospital
  • Fakultni nemocnice Brno
  • Fakultni nemocnice u sv. Anny v Brne
  • FN Hradec Kralove
  • Nemocnice Pardubickeho kraje, a.s. Pardubicka nemocnice
  • Fakultni nemocnice v Motole
  • Tampere University Hospital
  • Turku University Hospital
  • CHU de Montpellier Hôpital Gui de Chauliac- Département de Neurologie
  • CHU Nice - Hôpital Pasteur
  • CHU Nîmes
  • CHU de Poissy
  • CHU de Pontchaillou
  • Hôpital Civil
  • Universitätsklinikum Carl Gustav Carus
  • Universitätsklinikum Essen
  • Neurologische Praxis Eppendorf
  • Medizinische Hochschule Hannover
  • Klinik und Poliklinik fur Neurologie
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo
  • Barzilai Medical Center
  • Rambam MC
  • Sheba Medical Centre
  • Università "G. D'Annunzio" Chieti-Pescara Ospedale Cliniciz
  • Dipartimento di internistica clinica e sperimentale "Flaviano Magrassi"Università degli studi della Campania "Luigi Vanvitelli"
  • IRCSS Neuromed Istituto Neurologico Mediterraneo
  • Samodzielny Publiczny Szpital Kliniczny nr 7 SUM
  • Indywidualna Praktyka Lekarska Prof. Konrad Rejdak
  • Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanislawa Szyszko SUM w Katowicach
  • Hospital de Cruces
  • Hospital Vithas NISA Sevilla
  • Hospital Clinico San Carlos
  • Hospital Universitario Puerta de Hierro Majadahonda
  • Hospital La Fe
  • Sahlgrenska Universitetssjukhus
  • Akademiskt Specialist Centrum - Centrum för Neurologi,
  • Queen Elizabeth Hospital
  • University Hospital of Wales
  • Sheffield Teaching Hospitals Sheffield

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mavenclad®

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Time to First Disease Activity at Year 3 and 4
Time to First Disease Activity During up to 4 Years
Time to First New or Enlarging T2 Lesion
Time to First New T1 Gadolinium Enhancing (Gd+) Lesion
Time to First Confirmed Disability Progression (CDP) as measured by Expanded Disability Status Scale (EDSS)
Time to First Qualifying Relapse
Time to Second Qualifying Relapse
Time to Treatment Start with Other Disease Modifying Drugs (DMDs)
Time from Extension Study Baseline to First New or Enlarging T2 Lesion
Time from Extension Study Baseline to First New T1 Gadolinium Enhancing (Gd+) Lesion
Time from Extension Study Baseline to First Confirmed Disability Progression (CDP), as measured by Expanded Disability Status Scale (EDSS)
Time from Extension Study Baseline to First Qualifying Relapse
Time from Extension Study Baseline to Second Qualifying Relapse
Time from Extension Study Baseline to Treatment Start with Other Disease Modifying Drugs (DMDs)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Full Information

First Posted
March 3, 2021
Last Updated
September 7, 2023
Sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT04783935
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 10, 2021 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Mavenclad ®, Cladribine, Relapsing Multiple Sclerosis, Immune cell kinetics

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Open label, single arm, exploratory, multicenter, 2-year, Phase IV extension study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
219 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Responsible
Organizational Affiliation
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Liverpool Hospital
City
Liverpool
Country
Australia
Facility Name
John Hunter Hospital
City
New Lambton
Country
Australia
Facility Name
Klinikum Klagenfurt
City
Klagenfurt
Country
Austria
Facility Name
Paracelsus Medical University Salzburg
City
Salzburg
Country
Austria
Facility Name
University of Alberta
City
Edmonton
Country
Canada
Facility Name
Children's Hospital, London Health Sciences Centre- Pediatrics
City
London
Country
Canada
Facility Name
Montreal Neurological Hospital
City
Montreal
Country
Canada
Facility Name
Fakultni nemocnice Brno
City
Brno
Country
Czechia
Facility Name
Fakultni nemocnice u sv. Anny v Brne
City
Brno
Country
Czechia
Facility Name
FN Hradec Kralove
City
Hradec Kralove
Country
Czechia
Facility Name
Nemocnice Pardubickeho kraje, a.s. Pardubicka nemocnice
City
Pardubice
Country
Czechia
Facility Name
Fakultni nemocnice v Motole
City
Praha 5
Country
Czechia
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
Facility Name
Turku University Hospital
City
Turku
Country
Finland
Facility Name
CHU de Montpellier Hôpital Gui de Chauliac- Département de Neurologie
City
Montpellier
Country
France
Facility Name
CHU Nice - Hôpital Pasteur
City
Nice
Country
France
Facility Name
CHU Nîmes
City
Nimes
Country
France
Facility Name
CHU de Poissy
City
Poissy Cedex
Country
France
Facility Name
CHU de Pontchaillou
City
Rennes Cedex 9
Country
France
Facility Name
Hôpital Civil
City
Strasbourg Cedex
Country
France
Facility Name
Universitätsklinikum Carl Gustav Carus
City
Dresden
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
Country
Germany
Facility Name
Neurologische Praxis Eppendorf
City
Hamburg
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
Country
Germany
Facility Name
Klinik und Poliklinik fur Neurologie
City
Leipzig
Country
Germany
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo
City
Szeged
Country
Hungary
Facility Name
Barzilai Medical Center
City
Ashkelon
Country
Israel
Facility Name
Rambam MC
City
Haifa
Country
Israel
Facility Name
Sheba Medical Centre
City
Tel-Hashomer
Country
Israel
Facility Name
Università "G. D'Annunzio" Chieti-Pescara Ospedale Cliniciz
City
Chieti
Country
Italy
Facility Name
Dipartimento di internistica clinica e sperimentale "Flaviano Magrassi"Università degli studi della Campania "Luigi Vanvitelli"
City
Napoli
Country
Italy
Facility Name
IRCSS Neuromed Istituto Neurologico Mediterraneo
City
Pozzilli
Country
Italy
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 7 SUM
City
Katowice
Country
Poland
Facility Name
Indywidualna Praktyka Lekarska Prof. Konrad Rejdak
City
Lublin
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanislawa Szyszko SUM w Katowicach
City
Zabrze
Country
Poland
Facility Name
Hospital de Cruces
City
Baracaldo
Country
Spain
Facility Name
Hospital Vithas NISA Sevilla
City
Castilleja de la Cuesta
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Majadahonda
Country
Spain
Facility Name
Hospital La Fe
City
Valencia
Country
Spain
Facility Name
Sahlgrenska Universitetssjukhus
City
Göteborg
Country
Sweden
Facility Name
Akademiskt Specialist Centrum - Centrum för Neurologi,
City
Stockholm
Country
Sweden
Facility Name
Queen Elizabeth Hospital
City
Birmingham
Country
United Kingdom
Facility Name
University Hospital of Wales
City
Cardiff
Country
United Kingdom
Facility Name
Sheffield Teaching Hospitals Sheffield
City
Sheffield
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing Time Frame
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
IPD Sharing Access Criteria
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.
IPD Sharing URL
https://bit.ly/IPD21
Links:
URL
https://clinicaltrials.emdgroup.com/en/trial-details/?id=MS700568_0157
Description
Trial Awareness and Transparency website

Learn more about this trial

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

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