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

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 4

Conditions: Multiple Sclerosis

Treatments: Drug: Mavenclad®

Study type: Interventional

Funder types: Industry

Identifiers

NCT04783935

2020-003995-42 (EudraCT Number)

MS700568_0157

Details and patient eligibility

About

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).

Enrollment: 219 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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219 participants in 1 patient group

Mavenclad®

Experimental group

Treatment:

Drug: Mavenclad®