Phase 4 N=219 Other

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

Multiple Sclerosis

Bottom Line

View on ClinicalTrials.gov: NCT04783935 ↗

Enrolled (actual)

219

Serious AEs

5.9%

Results posted

Jan 2025

Primary outcome: Primary: Percentage of Participants With No Evidence of Disease Activity (Three Parameter [NEDA-3]) During Year 3 to 4 — 54.23 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Mavenclad® (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Primary completion: Sep 2023

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 or Enlarging T2 Lesion During Extension Study Period	25.07	—
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	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04783935). 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.