Clinical Trial Results:
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)
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Summary
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EudraCT number |
2020-003995-42 |
Trial protocol |
DE CZ HU FI AT PL IT |
Global end of trial date |
21 Sep 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
06 Oct 2024
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First version publication date |
06 Oct 2024
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
MS700568_0157
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04783935 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Merck Healthcare KGaA, Darmstadt, Germany
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Sponsor organisation address |
Frankfurter Strasse 250, Darmstadt, Germany, 64293
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Public contact |
Communication Centre, Merck Healthcare KGaA, Darmstadt, Germany, +49 6151725200, service@merckgroup.com
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Scientific contact |
Communication Center, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, +49 6151725200, service@merckgroup.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
21 Sep 2023
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
21 Sep 2023
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary purpose of this study was to evaluate the long-term effectiveness of Mavenclad® tablets, in terms of disease activity and safety, in subjects with highly active relapsing multiple sclerosis (RMS) previously participating in the MAGNIFY MS trial MS700568_0022 (NCT03364036).
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Protection of trial subjects |
Subject protection was ensured by following high medical and ethical standards in accordance with the principles laid down in the Declaration of Helsinki, and that are consistent with Good Clinical Practice and applicable regulations.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
03 Oct 2021
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 20
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Country: Number of subjects enrolled |
Austria: 3
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Country: Number of subjects enrolled |
Czechia: 78
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Country: Number of subjects enrolled |
Finland: 4
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Country: Number of subjects enrolled |
France: 19
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Country: Number of subjects enrolled |
Germany: 4
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Country: Number of subjects enrolled |
Hungary: 4
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Country: Number of subjects enrolled |
Italy: 6
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Country: Number of subjects enrolled |
Poland: 12
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Country: Number of subjects enrolled |
Spain: 35
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Country: Number of subjects enrolled |
Sweden: 8
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Country: Number of subjects enrolled |
Australia: 7
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Country: Number of subjects enrolled |
Canada: 9
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Country: Number of subjects enrolled |
Israel: 10
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Worldwide total number of subjects |
219
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EEA total number of subjects |
173
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
219
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||
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Pre-assignment
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Screening details |
The primary purpose of this study was to evaluate the long-term effectiveness of Mavenclad® tablets, in terms of disease activity and safety, in subjects with highly active relapsing multiple sclerosis (RMS) previously participating in the MAGNIFY MS trial MS700568_0022 (NCT03364036). | ||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||
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Arms
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Arm title
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Cladribine | ||||||||||||||||||
Arm description |
Subjects received oral Cladribine (tradename Mavenclad®) over 2 years, administered as 1 treatment course of 1.75 mg/kg body weight per year in MAGNIFY MS study. The treatment course consists of 2 treatment weeks, one at the beginning of the first month and one at the beginning of the second month of the respective treatment year. Each treatment week consists of 4 or 5 days on which a patient receives 10 mg or 20 mg (one or two tablets) as a single daily dose, depending on body weight. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Mavenclad
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Oral tablets
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Baseline characteristics reporting groups
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Reporting group title |
Cladribine
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Reporting group description |
Subjects received oral Cladribine (tradename Mavenclad®) over 2 years, administered as 1 treatment course of 1.75 mg/kg body weight per year in MAGNIFY MS study. The treatment course consists of 2 treatment weeks, one at the beginning of the first month and one at the beginning of the second month of the respective treatment year. Each treatment week consists of 4 or 5 days on which a patient receives 10 mg or 20 mg (one or two tablets) as a single daily dose, depending on body weight. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Cladribine
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Reporting group description |
Subjects received oral Cladribine (tradename Mavenclad®) over 2 years, administered as 1 treatment course of 1.75 mg/kg body weight per year in MAGNIFY MS study. The treatment course consists of 2 treatment weeks, one at the beginning of the first month and one at the beginning of the second month of the respective treatment year. Each treatment week consists of 4 or 5 days on which a patient receives 10 mg or 20 mg (one or two tablets) as a single daily dose, depending on body weight. | ||
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End point title |
Percentage of Participants with No Evidence of Disease Activity (Three Parameter [NEDA-3]) During Year 3 to 4 [1] | ||||||||
End point description |
The definition of NEDA-3 encompasses a combination of the following 3 related measures of disease activity: No relapses, no confirmed disability progression sustained for 12 weeks as measured on EDSS, and no magnetic resonance imaging (MRI) disease activity, defined as no gadolinium-enhancing (GdE) lesions and no new or enlarging T2 lesions. NEDA-3 was analyzed with the Kaplan-Meier (KM) time-to-event method to reduce the impact of unknown/missing information. The Full Analysis Set included all enrolled, eligible subjects.
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End point type |
Primary
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End point timeframe |
Year 3 to 4 after the initial dose of Mavenclad® tablets in parent study
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical and comparison analysis were performed in single arm for this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Participants with No Evidence of Disease Activity (Three Parameter [NEDA-3]) at Year 3 and 4 | ||||||||||||
End point description |
The definition of NEDA-3 encompasses a combination of the following 3 related measures of disease activity: No relapses, no confirmed disability progression sustained for 12 weeks as measured on EDSS, and no magnetic resonance imaging (MRI) disease activity, defined as no gadolinium-enhancing (GdE) lesions and no new or enlarging T2 lesions. NEDA-3 was analyzed with the Kaplan-Meier (KM) time-to-event method to reduce the impact of unknown/missing information.
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End point type |
Secondary
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End point timeframe |
At Year 3 and 4 after the initial dose of Mavenclad® tablets in parent study
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Participants with No Evidence of Disease Activity (Three Parameter [NEDA-3]) After the Start of Study Treatment During the Parent Study until the End of Year 3 and 4 | ||||||||||||
End point description |
The definition of NEDA-3 encompasses a combination of the following 3 related measures of disease activity: No relapses, no confirmed disability progression sustained for 12 weeks as measured on EDSS, and no magnetic resonance imaging (MRI) disease activity, defined as no gadolinium-enhancing (GdE) lesions and no new or enlarging T2 lesions. NEDA-3 was analyzed with the Kaplan-Meier (KM) time-to-event method to reduce the impact of unknown/missing information.
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End point type |
Secondary
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End point timeframe |
After the initial dose of Mavenclad® tablets in parent study until the end of Year 3 and 4
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| No statistical analyses for this end point | |||||||||||||
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End point title |
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 | ||||||||||||
End point description |
The definition of NEDA-3 encompasses a combination of the following 3 related measures of disease activity: No relapses, no confirmed disability progression sustained for 12 weeks as measured on EDSS, and no magnetic resonance imaging (MRI) disease activity, defined as no gadolinium-enhancing (GdE) lesions and no new or enlarging T2 lesions. NEDA-3 was analyzed with the Kaplan-Meier (KM) time-to-event method to reduce the impact of unknown/missing information.
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End point type |
Secondary
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End point timeframe |
At Year 3 and 4 after the initial dose of Mavenclad® tablets in parent study
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Time to Second Qualifying Relapse During Parent and Extension Study Period | ||||||||
End point description |
A qualifying relapse is defined as new, worsening or recurrent neurological symptoms attributed to Multiple Sclerosis (MS) that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days.
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End point type |
Secondary
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End point timeframe |
From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years)
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| Notes [2] - 9.99999 denotes values not calculable as fewer than 50% of participants experienced an event. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Time to First Qualifying Relapse During Parent and Extension Study Period | ||||||||
End point description |
A qualifying relapse is defined as new, worsening or recurrent neurological symptoms attributed to Multiple Sclerosis (MS) that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days.
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End point type |
Secondary
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End point timeframe |
From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years)
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| Notes [3] - 9.99999 denotes values not calculable as fewer than 50% of participants experienced an event. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Time to First Disease Activity During up to Parent and Extension study Period (4 Years) | ||||||||
End point description |
Time to first disease activity is defined as the time to first occurrence of either qualifying relapse, or 6MCDP, or new or enlarging T2-hyperintense lesions (active T2 lesions), or new T1 Gd+ lesions.
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End point type |
Secondary
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End point timeframe |
From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years)
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| No statistical analyses for this end point | |||||||||
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End point title |
Time to First Disease Activity During Extension Study Period (Year 3 and 4) | ||||||||
End point description |
Time to first disease activity is defined as the time to first occurrence of either qualifying relapse, or 6-month confirmed disability progression (6mCDP), or new or enlarging T2-hyperintense lesions (active T2 lesions), or new T1 Gd+ lesions.
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End point type |
Secondary
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End point timeframe |
From Month 24 after the initial dose of Mavenclad tablets in parent study until the end of extension study (approximately 2 years)
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| No statistical analyses for this end point | |||||||||
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End point title |
Time to Treatment Start with Other Disease Modifying Drugs (DMDs) During Parent and Extension Study Period | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years)
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| Notes [4] - 9.99999 denotes values not calculable as fewer than 50% of participants experienced an event. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Time to First Confirmed Disability Progression (CDP) as measured by Expanded Disability Status Scale (EDSS) During Parent and Extension Study Period | ||||||||
End point description |
The EDSS is an ordinal clinical rating scale in half-point increments. It assesses the following eight functional systems, areas of the central nervous system that control bodily functions: Pyramidal (ability to walk), Cerebellar (coordination), Brain stem (speech and swallowing), Sensory (touch and pain), Bowel and bladder functions, Visual, Mental, Other (includes any other neurological findings due to Multiple Sclerosis [MS]). EDSS overall score ranging from 0 (normal) to 10 (death due to MS). The 6MCDP during Extension Study Period is defined as sustained increase in EDSS score that started during the Period. Six-month CDP was considered.
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End point type |
Secondary
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End point timeframe |
From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years)
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| Notes [5] - 9.99999 denotes values not calculable as fewer than 50% of participants experienced an event. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Time to First New T1 Gadolinium Enhancing (Gd+) Lesion During Parent and Extension Study Period | ||||||||
End point description |
Time taken for newly enlarging T1 Gadolinium Enhancing (Gd+) Lesion to show up is measured by follow-up MRI.
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End point type |
Secondary
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End point timeframe |
From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years)
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| Notes [6] - 99999 denotes values not calculable as fewer than 50% of participants experienced an event. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | ||||||||||
End point description |
An adverse event (AE) was defined as any untoward medical occurrence in a participant. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a study intervention. A serious adverse event (SAE) was any untoward medical occurrence that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important.
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End point type |
Secondary
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End point timeframe |
From Month 24 after the initial dose of Mavenclad tablets in parent study until the end of extension study (approximately 4 years)
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| No statistical analyses for this end point | |||||||||||
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End point title |
Time to First New or Enlarging T2 Lesion During Extension Study Period | ||||||||
End point description |
Time taken for newly enlarging T2 lesions to show up is measured by follow-up MRI.
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End point type |
Secondary
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End point timeframe |
From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years)
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| No statistical analyses for this end point | |||||||||
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End point title |
Time to First New T1 Gadolinium Enhancing (Gd+) Lesion During Extension Study Period | ||||||||
End point description |
Time taken for newly enlarging T1 Gadolinium Enhancing (Gd+) Lesion to show up is measured by follow-up MRI.
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End point type |
Secondary
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End point timeframe |
From Month 24 after the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 2 years)
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| Notes [7] - 9.99999 denotes values not calculable as fewer than 50% of participants experienced an event. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Time to First Confirmed Disability Progression (CDP) as measured by Expanded Disability Status Scale (EDSS) During Extension Study Period | ||||||||
End point description |
he EDSS is an ordinal clinical rating scale in half-point increments. It assesses the following eight functional systems, areas of the central nervous system that control bodily functions: Pyramidal (ability to walk), Cerebellar (coordination), Brain stem (speech and swallowing), Sensory (touch and pain), Bowel and bladder functions, Visual, Mental, Other (includes any other neurological findings due to Multiple Sclerosis [MS]). EDSS overall score ranging from 0 (normal) to 10 (death due to MS) The 6MCDP during Extension Study Period is defined as sustained increase in EDSS score that started during the Period. Six-month CDP was considered.
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End point type |
Secondary
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End point timeframe |
From Month 24 after the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 2 years)
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| Notes [8] - 9.99999 denotes values not calculable as fewer than 50% of participants experienced an event. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Time to First Qualifying Relapse During Extension Study Period | ||||||||
End point description |
A qualifying relapse is defined as new, worsening or recurrent neurological symptoms attributed to Multiple Sclerosis (MS) that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days.
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End point type |
Secondary
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End point timeframe |
From Month 24 after the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 2 years)
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| Notes [9] - 9.99999 denotes values not calculable as fewer than 50% of participants experienced an event. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Time to Recurrent Qualifying Relapse During Extension Study Period | ||||||||
End point description |
A qualifying relapse is defined as new, worsening or recurrent neurological symptoms attributed to Multiple Sclerosis (MS) that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days.
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End point type |
Secondary
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End point timeframe |
From Month 24 after the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 2 years)
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| Notes [10] - 9.99999 denotes values not calculable as fewer than 50% of participants experienced an event. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Time to Treatment Start with Other Disease Modifying Drugs (DMDs) During Extension Study Period | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
From Month 24 after the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 2 years)
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| Notes [11] - 9.99999 denotes values not calculable as fewer than 50% of participants experienced an event. |
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| No statistical analyses for this end point | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
From Month 24 after the initial dose of Mavenclad tablets in parent study until the end of extension study (approximately 4 years)
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
26.0
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Reporting groups
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Reporting group title |
Cladribine
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Reporting group description |
Participants received oral Cladribine (tradename Mavenclad®) over 2 years, administered as 1 treatment course of 1.75 mg/kg body weight per year. The treatment course consists of 2 treatment weeks, one at the beginning of the first month and one at the beginning of the second month of the respective treatment year. Each treatment week consists of 4 or 5 days on which a patient receives 10 mg or 20 mg (one or two tablets) as a single daily dose, depending on body weight. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| NEDA-3 may be limited by sparse measurement of EDSS this may have resulted in an overestimation of NEDA-3 rate each year. The 6mCDP needs confirmatory visit however most subjects had only 1 visit during each period which may led to underestimation. | |||
