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Multiple SclerosisPhase 4NCT04783935

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

A Phase 4 study testing Mavenclad® in people with Multiple Sclerosis, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 46 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Sclerosis
What is being tested?
Mavenclad®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
219 participants
Where
46 sitesin 14 countries
Study dates
10 Mar 2021to 21 Sep 2023
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Participant is considered by the Investigator, for any reason, to be an unsuitable candidate for the study
  • Participation in other studies/trials

Trial locations and contacts

46 sites in 14 countries.

46 sites in 14 countries

France6 sites

  • CHU de Montpellier Hôpital Gui de Chauliac- Département de Neurologie

    Montpellier

  • CHU Nice - Hôpital Pasteur

    Nice

  • CHU Nîmes

    Nîmes

  • CHU de Poissy

    Poissy

  • CHU de Pontchaillou

    Rennes

  • Hôpital Civil

    Strasbourg

Other trials in France

Czechia5 sites

  • Fakultni nemocnice Brno

    Brno

  • Fakultni nemocnice u sv. Anny v Brne

    Brno

  • FN Hradec Kralove

    Hradec Králové

  • Nemocnice Pardubickeho kraje, a.s. Pardubicka nemocnice

    Pardubice

  • Fakultni nemocnice v Motole

    Prague

Other trials in Czechia

Germany5 sites

  • Universitätsklinikum Carl Gustav Carus

    Dresden

  • Universitätsklinikum Essen

    Essen

  • Neurologische Praxis Eppendorf

    Hamburg

  • Medizinische Hochschule Hannover

    Hanover

  • Klinik und Poliklinik fur Neurologie

    Leipzig

Other trials in Germany

Spain5 sites

  • Hospital de Cruces

    Barakaldo

  • Hospital Vithas NISA Sevilla

    Castilleja de la Cuesta

  • Hospital Clinico San Carlos

    Madrid

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda

  • Hospital La Fe

    Valencia

Other trials in Spain

Canada4 sites

  • University of Alberta

    Edmonton

  • Children's Hospital, London Health Sciences Centre- Pediatrics

    London

  • Montreal Neurological Hospital

    Montreal

  • MS Clinical Trials Group

    Vancouver

Other trials in Canada

Israel3 sites

  • Barzilai Medical Center

    Ashkelon

  • Rambam MC

    Haifa

  • Sheba Medical Centre

    Tel HaShomer

Other trials in Israel

Italy3 sites

  • Università "G. D'Annunzio" Chieti-Pescara Ospedale Cliniciz

    Chieti

  • Dipartimento di internistica clinica e sperimentale "Flaviano Magrassi"Università degli studi della Campania "Luigi Vanvitelli"

    Naples

  • IRCSS Neuromed Istituto Neurologico Mediterraneo

    Pozzilli

Other trials in Italy

Poland3 sites

  • Samodzielny Publiczny Szpital Kliniczny nr 7 SUM

    Katowice

  • Indywidualna Praktyka Lekarska Prof. Konrad Rejdak

    Lublin

  • Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanislawa Szyszko SUM w Katowicach

    Zabrze

Other trials in Poland

United Kingdom3 sites

  • Queen Elizabeth Hospital

    Birmingham

  • University Hospital of Wales

    Cardiff

  • Sheffield Teaching Hospitals Sheffield

    Sheffield

Other trials in United Kingdom

Australia2 sites

  • Liverpool Hospital

    Liverpool

  • John Hunter Hospital

    New Lambton

Other trials in Australia

Austria2 sites

  • Klinikum Klagenfurt

    Klagenfurt

  • Paracelsus Medical University Salzburg

    Salzburg

Other trials in Austria

Finland2 sites

  • Tampere University Hospital

    Tampere

  • Turku University Hospital

    Turku

Other trials in Finland

Sweden2 sites

  • Sahlgrenska Universitetssjukhus

    Gothenburg

  • Akademiskt Specialist Centrum - Centrum för Neurologi,

    Stockholm

Other trials in Sweden

Hungary1 site

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo

    Szeged

Other trials in Hungary

About this study

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)

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).

Being tested
Mavenclad®
Keywords
Multiple Sclerosis, Mavenclad ®, Cladribine, Relapsing Multiple Sclerosis, Immune cell kinetics
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mavenclad®Drug

    Also called Cladribine

    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).

Study groups in NCT04783935
Study groupRoleWhat they receive
Mavenclad®ExperimentalNot described
Receives: Drug: Mavenclad®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With No Evidence of Disease Activity (Three Parameter [NEDA-3]) During Year 3 to 4

    The definition of NEDA-3 encompasses a combination of the following 3 related measures of disease activity: No relapses, no confirmed disability progression sustained for 12 weeks as measured on EDSS, and no magnetic resonance imaging (MRI) disease activity, defined as no gadolinium-enhancing (GdE) lesions and no new or enlarging T2 lesions. NEDA-3 was analyzed with the Kaplan-Meier (KM) time-to-event method to reduce the impact of unknown/missing information. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. An EDSS progression was defined as an increase of the EDSS score of at least 1.5 point compared to baseline for participants with a baseline EDSS of 0. For participants with an EDSS score between 0.5 and 4.5 at baseline (SD1), EDSS progression was defined as an increase of at least 1 point. For participants with baseline EDSS score of 5, EDSS progression was defined as an increase of at least 0.5.

    Measured: Year 3 to 4 after the initial dose of Mavenclad® tablets in parent study

Secondary outcomes (18)

  1. Percentage of Participants With No Evidence of Disease Activity (Three Parameter [NEDA-3]) at Year 3 and at Year 4

    The definition of NEDA-3 encompasses a combination of the following 3 related measures of disease activity: No relapses, no confirmed disability progression sustained for 12 weeks as measured on EDSS, and no magnetic resonance imaging (MRI) disease activity, defined as no gadolinium-enhancing (GdE) lesions and no new or enlarging T2 lesions. NEDA-3 was analyzed with the Kaplan-Meier (KM) time-to-event method to reduce the impact of unknown/missing information. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. An EDSS progression was defined as an increase of the EDSS score of at least 1.5 point compared to baseline for participants with a baseline EDSS of 0. For participants with an EDSS score between 0.5 and 4.5 at baseline (SD1), EDSS progression was defined as an increase of at least 1 point. For participants with baseline EDSS score of 5, EDSS progression was defined as an increase of at least 0.5.

    Measured: At Year 3 and 4 after the initial dose of Mavenclad® tablets in parent study

  2. 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

    The definition of NEDA-3 encompasses a combination of the following 3 related measures of disease activity: No relapses, no confirmed disability progression sustained for 12 weeks as measured on EDSS, and no magnetic resonance imaging (MRI) disease activity, defined as no gadolinium-enhancing (GdE) lesions and no new or enlarging T2 lesions. NEDA-3 was analyzed with the Kaplan-Meier (KM) time-to-event method to reduce the impact of unknown/missing information. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. An EDSS progression was defined as an increase of the EDSS score of at least 1.5 point compared to baseline for participants with a baseline EDSS of 0. For participants with an EDSS score between 0.5 and 4.5 at baseline (SD1), EDSS progression was defined as an increase of at least 1 point. For participants with baseline EDSS score of 5, EDSS progression was defined as an increase of at least 0.5.

    Measured: After the initial dose of Mavenclad® tablets in parent study until the end of Year 3 and 4

  3. 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

    The definition of NEDA-3 encompasses a combination of the following 3 related measures of disease activity: No relapses, no confirmed disability progression sustained for 12 weeks as measured on EDSS, and no magnetic resonance imaging (MRI) disease activity, defined as no gadolinium-enhancing (GdE) lesions and no new or enlarging T2 lesions. NEDA-3 was analyzed with the Kaplan-Meier (KM) time-to-event method to reduce the impact of unknown/missing information. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. An EDSS progression was defined as an increase of the EDSS score of at least 1.5 point compared to baseline for participants with a baseline EDSS of 0. For participants with an EDSS score between 0.5 and 4.5 at baseline (SD1), EDSS progression was defined as an increase of at least 1 point. For participants with baseline EDSS score of 5, EDSS progression was defined as an increase of at least 0.5.

    Measured: At Year 3 and 4 after the initial dose of Mavenclad® tablets in parent study

  4. Time to First Disease Activity During Extension Study Period

    Time to first disease activity is defined as the time to first occurrence of either qualifying relapse, or 6-month confirmed disability progression (6mCDP), or new or enlarging T2-hyperintense lesions (active T2 lesions), or new T1 Gd+ lesions. The 6MCDP during Extension Study Period is defined as sustained increase in EDSS score that started during the Period. Six-month CDP was considered.

    Measured: From Month 24 after the initial dose of Mavenclad tablets in parent study until the end of extension study (approximately 2 years)

  5. Time to First Disease Activity During up to Parent and Extension Study Period (4 Years)

    Time to first disease activity is defined as the time to first occurrence of either qualifying relapse, or 6MCDP, or new or enlarging T2-hyperintense lesions (active T2 lesions), or new T1 Gd+ lesions. The 6MCDP during Extension Study Period is defined as sustained increase in EDSS score that started during the Period. Six-month CDP was considered.

    Measured: From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years)

  6. Time to First New or Enlarging T2 Lesion During Extension Study Period

    Time taken for newly enlarging T2 lesions to show up is measured by follow-up MRI.

    Measured: From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years)

  7. Time to First New T1 Gadolinium Enhancing (Gd+) Lesion During Parent and Extension Study Period

    Time taken for newly enlarging T1 Gadolinium Enhancing (Gd+) Lesion to show up is measured by follow-up MRI. Kaplan - Meier estimates were used for calculation of data.

    Measured: From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years)

  8. Time to First Confirmed Disability Progression (CDP) as Measured by Expanded Disability Status Scale (EDSS) During Parent and Extension Study Period

    EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. An EDSS progression was defined as an increase of the EDSS score of at least 1.5 point compared to baseline for participants with a baseline EDSS of 0. For participants with an EDSS score between 0.5 and 4.5 at baseline (SD1), EDSS progression was defined as an increase of at least 1 point. For participants with baseline EDSS score of 5, EDSS progression was defined as an increase of at least 0.5. Kaplan - Meier estimates were used for calculation of data.

    Measured: From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years)

  9. Time to First Qualifying Relapse During Parent and Extension Study Period

    A qualifying relapse is defined as new, worsening or recurrent neurological symptoms attributed to Multiple Sclerosis (MS) that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. Kaplan - Meier estimates were used for calculation of data.

    Measured: From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years)

  10. Time to Recurrent Qualifying Relapse During Parent and Extension Study Period

    A qualifying relapse is defined as new, worsening or recurrent neurological symptoms attributed to Multiple Sclerosis (MS) that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. Kaplan - Meier estimates were used for calculation of data.

    Measured: From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years)

  11. Time to Treatment Start With Other Disease Modifying Drugs (DMDs) During Parent and Extension Study Period

    Time to Treatment Start with Other Disease Modifying Drugs (DMDs) During Parent and Extension Study Period. Kaplan - Meier estimates were used for calculation of data.

    Measured: From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years)

  12. Time to First New or Enlarging T2 Lesion During Extension Study Period

    Time taken for newly enlarging T2 Gadolinium Enhancing (Gd+) Lesion to show up is measured by follow-up MRI. Kaplan - Meier estimates were used for calculation of data.

    Measured: From Month 24 after the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 2 years)

  13. Time to First New T1 Gadolinium Enhancing (Gd+) Lesion During Extension Study Period

    Time taken for newly enlarging T1 Gadolinium Enhancing (Gd+) Lesion to show up is measured by follow-up MRI. Kaplan - Meier estimates were used for calculation of data.

    Measured: From Month 24 after the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 2 years)

  14. Time to First Confirmed Disability Progression (CDP) as Measured by Expanded Disability Status Scale (EDSS) During Extension Study Period

    The EDSS is an ordinal clinical rating scale in half-point increments. It assesses the following eight functional systems, areas of the central nervous system that control bodily functions: Pyramidal (ability to walk), Cerebellar (coordination), Brain stem (speech and swallowing), Sensory (touch and pain), Bowel and bladder functions, Visual, Mental, Other (includes any other neurological findings due to Multiple Sclerosis [MS]). EDSS overall score ranging from 0 (normal) to 10 (death due to MS). The 6MCDP during Extension Study Period is defined as sustained increase in EDSS score that started during the Period. Six-month CDP was considered.

    Measured: From Month 24 after the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 2 years)

  15. Time to First Qualifying Relapse During Extension Study Period

    A qualifying relapse is defined as new, worsening or recurrent neurological symptoms attributed to Multiple Sclerosis (MS) that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. Kaplan - Meier estimates were used for calculation of data.

    Measured: From Month 24 after the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 2 years)

  16. Time to Recurrent Qualifying Relapse During Extension Study Period

    A qualifying relapse is defined as new, worsening or recurrent neurological symptoms attributed to Multiple Sclerosis (MS) that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days.

    Measured: From Month 24 after the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 2 years)

  17. Time to Treatment Start With Other Disease Modifying Drugs (DMDs) During Extension Study Period

    Time to Treatment Start with Other Disease Modifying Drugs (DMDs) During Parent and Extension Study Period. Kaplan - Meier estimates were used for calculation of data.

    Measured: From Month 24 after the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 2 years)

  18. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    An adverse event (AE) was defined as any untoward medical occurrence in a participant. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a study intervention. A serious adverse event (SAE) was any untoward medical occurrence that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important.

    Measured: From Month 24 after the initial dose of Mavenclad tablets in parent study until the end of extension study (approximately 2 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2021
  2. Study start10 Mar 2021
  3. Primary completion21 Sep 2023
  4. Study completion21 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Open label, single arm, exploratory, multicenter, 2-year, Phase IV extension study.
Masking
None (open label)
Enrolment
219 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04783935
Sponsor's protocol ID
MS700568_0157
Other IDs
2020-003995-42
Status last verified
Dec 2024
First submitted
3 Mar 2021
Last updated
22 Jan 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • De Stefano N, Vermersch P, Wiendl H, Barkhof F, Montalban X, Achiron A, Derfuss T, Chan A, Prat A, Leocani L, Schmierer K, Sellebjerg F, Nolting A, Petit C, Guala D, Sponton L, Gardner L, Hodgkinson S. Long-term efficacy of cladribine tablets: Results from the MAGNIFY-MS Extension study. Mult Scler. 2026 Aug 4:13524585261467624. doi: 10.1177/13524585261467624. Online ahead of print.

    PubMed 42548205

  • Schmierer K, Wiendl H, Barkhof F, Montalban X, Achiron A, Derfuss T, Chan A, Hodgkinson S, Prat A, Leocani L, Sellebjerg F, Vermersch P, Jin H, Sponton L, Chudecka A, Bucello M, Gardner L, De Stefano N. A plain language summary on clinical and mechanistic effects of cladribine in relapsing multiple sclerosis: 2-year results from the MAGNIFY-MS study. Neurodegener Dis Manag. 2026 Apr 6:1-11. doi: 10.1080/17582024.2026.2646302. Online ahead of print.

    PubMed 41943490

  • Schmierer K, Wiendl H, Barkhof F, Montalban X, Achiron A, Derfuss T, Chan A, Hodgkinson S, Prat A, Leocani L, Sellebjerg F, Vermersch P, Jin H, Sponton L, Chudecka A, Gardner L, De Stefano N. Clinical and mechanistic effects of cladribine in relapsing multiple sclerosis: 2-year results from the MAGNIFY-MS Study. Ther Adv Neurol Disord. 2025 Jul 31;18:17562864251351760. doi: 10.1177/17562864251351760. eCollection 2025.

    PubMed 40756532

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Mavenclad® in people with Multiple Sclerosis, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 46 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in France, Czechia, Germany, Spain, Canada and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With No Evidence of Disease Activity (Three Parameter [NEDA-3]) During Year 3 to 4 (time frame: Year 3 to 4 after the initial dose of Mavenclad® tablets in parent study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04783935, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.

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