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Magnify MS Extension

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)
CompletedPhase 4Relapsing MSNCT047839352020-003995-42

What it found

Results posted, no main test reported

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

Results by group

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

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

GroupValueIntervalNumber analysed
Cladribine54.23 percentage of participants47.26–60.68219

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Cladribine21913 (5.9%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

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

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

    Disability progressionRelapsesMRI lesions

  • Proportion of participants with No Evidence of Disease Activity (three parameter [NEDA-3]) during Year 3 and 4 after the initial dose of cladribine tablets.

Other measures (19)

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

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

    Disability progressionRelapsesMRI lesions

  • 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

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

    Disability progressionRelapsesMRI lesions

  • 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

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

    Disability progressionRelapsesMRI lesions

  • Time to First Disease Activity During Extension Study Period

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

    Disability progressionRelapsesMRI lesions

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

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

    Disability progressionRelapsesMRI lesions

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

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

    MRI lesions

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

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

    MRI lesions

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

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

    Disability progression

  • Time to First Qualifying Relapse During Parent and Extension Study Period

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

    RelapsesSafety

  • Time to Recurrent Qualifying Relapse During Parent and Extension Study Period

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

    RelapsesSafety

Who could take part

Relapsing MS · 18 and over

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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).

Papers

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Linked trials

Links found where a registry record names another trial's registry number.

Related trials

History

    1. Started

      Mar 2021

    2. Main results due

      Sept 2023

    3. Finished

      Sept 2023

    4. Results posted

      Jan 2025

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