Extension to the MAGNIFY MS trial on Mavenclad®

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003995-42-FI

Enrollment

256

Registered

2020-11-23

Start date

2020-12-15

Completion date

Unknown

Last updated

2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Highly-active relapsing multiple sclerosis MedDRA version: 20.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.0 Level: PT Classification code 10080700 Term: Relapsing multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: Mavenclad Product Name: Cladribine tablets Product Code: Not applicable Pharmaceutical Form: Tablet INN or Proposed INN: CLADRIBINE CAS Number: 4291-63-8 Concentration unit: mg milligram(s

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Participants of the MAGNIFY MS trial who received at least a single dose of cladribine tablets during the MAGNIFY MS trial and data on MRI is available/acquired from at least parent study Month 18 or Month 24 visit and EDSS and relapse from parent study Month 24 visit. 2. Capable of giving signed informed consent, as indicated in Appendix 2, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 256 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Participant is considered by the Investigator, for any reason, to be an unsuitable candidate for the study. 2. Participation in other studies/trials.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the long-term disease activity during Year 3 and 4 after initial dose of cladribine tablets;Secondary Objective: 1. To further explore the long-term treatment effect of cladribine tablets; 2. To evaluate the long-term safety of cladribine tablets ;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: Visit 1: 12 months (+/- 30 days) after parent study last visit Visit 2: 24 months (+/- 30 days) after parent study last visit	—

Measure

Time frame

Main Objective: To evaluate the long-term disease activity during Year 3 and 4 after initial dose of cladribine tablets;Secondary Objective: 1. To further explore the long-term treatment effect of cladribine tablets; 2. To evaluate the long-term safety of cladribine tablets ;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: Visit 1: 12 months (+/- 30 days) after parent study last visit Visit 2: 24 months (+/- 30 days) after parent study last visit

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Secondary

Measure	Time frame
Secondary end point(s): • Proportion of participants with NEDA-3 during Year 3 after the initial dose of cladribine tablets • Proportion of participants with NEDA-3 during Year 4 after the initial dose of cladribine tablets • Proportion of participants with NEDA-3 after the onset of action of cladribine treatment during the parent study until the end of Year 3 after initial dose of cladribine tablets • Proportion of participants with NEDA-3 after onset of action of cladribine treatment during the parent study until the end of Year 4 after the initial dose of cladribine tablets • Proportion of participants remaining NEDA-3 during Year 3 or 4 after the initial dose of cladribine tablets among those with NEDA-3 during Year 1 or 2 after the initial dose of cladribine tablets • Time to first disease activity, de?ned as time to ?rst occurrence of either qualifying relapse, or confirmed disability progression (CDP), or new or enlarging T2-hyperintense lesions, or new T1 gadolinium enhancing (Gd+) lesions, during Year 3 and 4 after the initial dose of cladribine tablets • Time to first disease activity, de?ned as time to first occurrence of either qualifying relapse, or CDP, or new or enlarging T2-hyperintense lesions, or new T1 Gd+ lesions, over 4 years after the initial dose of cladribine (i.e., between the initial dose of cladribine tablets and end of the extension study) • Time from the initial dose of cladribine tablets to - first new or enlarging T2 lesion - first new T1 Gd+ lesion - first CDP, as measured by Expanded Disability Status Scale (EDSS) - first qualifying relapse - second qualifying relapse - treatment start with other disease modifying drugs (DMDs) • Time from extension study Baseline to - first new or enlarging T2 lesion - first new T1 Gd+ lesion - first CDP, as measured by EDSS - first qualifying relapse - second qualifying relapse - treatment start with other DMDs ;Timepoint(s) of evaluation of this end point: Visit 1: 12 months (+/-	—

Measure

Time frame

Secondary end point(s): • Proportion of participants with NEDA-3 during Year 3 after the initial dose of cladribine tablets • Proportion of participants with NEDA-3 during Year 4 after the initial dose of cladribine tablets • Proportion of participants with NEDA-3 after the onset of action of cladribine treatment during the parent study until the end of Year 3 after initial dose of cladribine tablets • Proportion of participants with NEDA-3 after onset of action of cladribine treatment during the parent study until the end of Year 4 after the initial dose of cladribine tablets • Proportion of participants remaining NEDA-3 during Year 3 or 4 after the initial dose of cladribine tablets among those with NEDA-3 during Year 1 or 2 after the initial dose of cladribine tablets • Time to first disease activity, de?ned as time to ?rst occurrence of either qualifying relapse, or confirmed disability progression (CDP), or new or enlarging T2-hyperintense lesions, or new T1 gadolinium enhancing (Gd+) lesions, during Year 3 and 4 after the initial dose of cladribine tablets • Time to first disease activity, de?ned as time to first occurrence of either qualifying relapse, or CDP, or new or enlarging T2-hyperintense lesions, or new T1 Gd+ lesions, over 4 years after the initial dose of cladribine (i.e., between the initial dose of cladribine tablets and end of the extension study) • Time from the initial dose of cladribine tablets to - first new or enlarging T2 lesion - first new T1 Gd+ lesion - first CDP, as measured by Expanded Disability Status Scale (EDSS) - first qualifying relapse - second qualifying relapse - treatment start with other disease modifying drugs (DMDs) • Time from extension study Baseline to - first new or enlarging T2 lesion - first new T1 Gd+ lesion - first CDP, as measured by EDSS - first qualifying relapse - second qualifying relapse - treatment start with other DMDs ;Timepoint(s) of evaluation of this end point: Visit 1: 12 months (+/-

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Countries

Australia, Austria, Canada, Czech Republic, Finland, Germany, Hungary, Israel, Italy, Poland

Contacts

Public ContactCommunication Center Merck KGaA

Merck Healthcare KGaA

service@merckgroup.com49615172 5200

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026