Phase 4
Completed N=219
Extension to the MAGNIFY MS Trial on Mavenclad® (Magnify MS Extension)
Source: ClinicalTrials.gov NCT04783935 ↗Enrolled (actual)
219
Serious AEs
5.9%
Results posted
Jan 2025
Primary outcomePrimary: Percentage of Participants With No Evidence of Disease Activity (Three Parameter [NEDA-3]) During Year 3 to 4 — 54.23 percentage of participants
◆ Published Evidence
Emerging
11citations · ~11 / year
Clinical and mechanistic effects of cladribine in relapsing multiple sclerosis: 2-year results from the MAGNIFY-MS Study.
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).
Linked Publications (2)
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Clinical and mechanistic effects of cladribine in relapsing multiple sclerosis: 2-year results from the MAGNIFY-MS Study.
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A plain language summary on clinical and mechanistic effects of cladribine in relapsing multiple sclerosis: 2-year results from the MAGNIFY-MS study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With No Evidence of Disease Activity (Three Parameter [NEDA-3]) During Year 3 to 4 |
54.23 | — |
| SECONDARY Percentage of Participants With No Evidence of Disease Activity (Three Parameter [NEDA-3]) at Year 3 and at Year 4 |
81.63; 79.20 | — |
| SECONDARY 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 |
31.89; 26.72 | — |
| 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 |
92.93; 90.04; 84.86; 81.92 | — |
| SECONDARY Time to First Disease Activity During Extension Study Period |
24.05 | — |
| SECONDARY Time to First Disease Activity During up to Parent and Extension Study Period (4 Years) |
6.14 | — |
| SECONDARY Time to First New or Enlarging T2 Lesion During Extension Study Period |
25.07 | — |
| SECONDARY Time to First New T1 Gadolinium Enhancing (Gd+) Lesion During Parent and Extension Study Period |
NA | — |
| SECONDARY Time to First Confirmed Disability Progression (CDP) as Measured by Expanded Disability Status Scale (EDSS) During Parent and Extension Study Period |
NA | — |
| SECONDARY Time to First Qualifying Relapse During Parent and Extension Study Period |
NA | — |
| SECONDARY Time to Recurrent Qualifying Relapse During Parent and Extension Study Period |
NA | — |
| SECONDARY Time to Treatment Start With Other Disease Modifying Drugs (DMDs) During Parent and Extension Study Period |
— | — |
| SECONDARY Time to First New T1 Gadolinium Enhancing (Gd+) Lesion During Extension Study Period |
NA | — |
| SECONDARY Time to First Confirmed Disability Progression (CDP) as Measured by Expanded Disability Status Scale (EDSS) During Extension Study Period |
NA | — |
| SECONDARY Time to First Qualifying Relapse During Extension Study Period |
NA | — |
| SECONDARY Time to Recurrent Qualifying Relapse During Extension Study Period |
NA | — |
| SECONDARY Time to Treatment Start With Other Disease Modifying Drugs (DMDs) During Extension Study Period |
— | — |
| SECONDARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
142; 13 | — |
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
Data sourced from ClinicalTrials.gov (NCT04783935) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.