Extension to the MAGNIFY MS trial on Mavenclad®

Phase 1

• Conditions: Highly-active relapsing multiple sclerosis; MedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 21.0Level: PTClassification code 10080700Term: Relapsing multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2020-003995-42-FI
• Lead Sponsor: Merck Healthcare KGaA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-23
• Last Update Posted: 19 December 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 256

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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;<br>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<br>Visit 2: 24 months (+/- 30 days) after parent study last visit