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

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is 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).

Official Title
-----------------
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)

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: Mavenclad®


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Open label, single arm, exploratory, multicenter, 2-year, Phase IV extension study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mavenclad®<br> | Drug: Mavenclad®<br>* No intervention will be administered as a part of this study. Participants who had received Mavenclad® up to 2 years (Year 1 and 2) in the parent study MS700568_0022 (NCT03364036) will be enrolled into this extension study and will be assessed up to 2 years follow-up (Year 3 and 4).<br>* Other names: Cladribine;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with No Evidence of Disease Activity (Three Parameter [NEDA-3]) During Year 3 to 4 | NEDA 3: no clinical relapse, no Magnetic Resonance Imaging (MRI) activity, no disability progression. | Year 3 to 4 after the initial dose of Mavenclad® tablets in parent study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with No Evidence of Disease Activity (Three Parameter [NEDA-3]) at Year 3 and 4 | NEDA 3: no clinical relapse, no Magnetic Resonance Imaging (MRI) activity, no disability progression. | At Year 3 and 4 after the initial dose of Mavenclad® tablets in parent study | 
| Percentage of Participants with No Evidence of Disease Activity (Three Parameter [NEDA-3]) After the Onset of Action of Mavenclad® Treatment During the Parent Study until the End of Year 3 and 4 | NEDA 3: no clinical relapse, no Magnetic Resonance Imaging (MRI) activity, no disability progression. | After the initial dose of Mavenclad® tablets in parent study until the end of Year 3 and 4 | 
| 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 | NEDA 3: no clinical relapse, no Magnetic Resonance Imaging (MRI) activity, no disability progression. | At Year 3 and 4 after the initial dose of Mavenclad® tablets in parent study | 
| Time to First Disease Activity at Year 3 and 4 |  | At Year 3 and 4 after the initial dose of Mavenclad® tablets in parent study | 
| Time to First Disease Activity During up to 4 Years |  | From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years) | 
| Time to First New or Enlarging T2 Lesion |  | From the initial dose of Mavenclad® tables in parent study until the end of extension study (approximately 4 years) | 
| Time to First New T1 Gadolinium Enhancing (Gd+) Lesion |  | From the initial dose of Mavenclad® tables in parent study until the end of extension study (approximately 4 years) | 
| Time to First Confirmed Disability Progression (CDP) as measured by Expanded Disability Status Scale (EDSS) |  | From the initial dose of Mavenclad® tables in parent study until the end of extension study (approximately 4 years) | 
| Time to First Qualifying Relapse |  | From the initial dose of Mavenclad® tables in parent study until the end of extension study (approximately 4 years) | 
| Time to Second Qualifying Relapse |  | From the initial dose of Mavenclad® tables in parent study until the end of extension study (approximately 4 years) | 
| Time to Treatment Start with Other Disease Modifying Drugs (DMDs) |  | From the initial dose of Mavenclad® tables in parent study until the end of extension study (approximately 4 years) | 
| Time from Extension Study Baseline to First New or Enlarging T2 Lesion |  | Time from Baseline (extension study), up to 2 years | 
| Time from Extension Study Baseline to First New T1 Gadolinium Enhancing (Gd+) Lesion |  | Time from Baseline (extension study), up to 2 years | 
| Time from Extension Study Baseline to First Confirmed Disability Progression (CDP), as measured by Expanded Disability Status Scale (EDSS) |  | Time from Baseline (extension study), up to 2 years | 
| Time from Extension Study Baseline to First Qualifying Relapse |  | Time from Baseline (extension study), up to 2 years | 
| Time from Extension Study Baseline to Second Qualifying Relapse |  | Time from Baseline (extension study), up to 2 years | 
| Time from Extension Study Baseline to Treatment Start with Other Disease Modifying Drugs (DMDs) |  | Time from Baseline (extension study), up to 2 years | 
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |  | Up to Year 3 and 4 after the initial dose of Mavenclad® tablets in parent study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis, Mavenclad ®, Cladribine, Relapsing Multiple Sclerosis, Immune cell kinetics