| Primary | Percentage of Participants With No Evidence of Disease Activity (Three Parameter [NEDA-3]) During Year 3 to 4 | 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. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. An EDSS progression was defined as an increase of the EDSS score of at least 1.5 point compared to baseline for participants with a baseline EDSS of 0. For participants with an EDSS score between 0.5 and 4.5 at baseline (SD1), EDSS progression was defined as an increase of at least 1 point. For participants with baseline EDSS score of 5, EDSS progression was defined as an increase of at least 0.5. | The Full Analysis Set included all enrolled, eligible participants. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Year 3 to 4 after the initial dose of Mavenclad® tablets in parent study | | | | ID | Title | Description |
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| OG000 | Cladribine | Participants 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 parent 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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| | | Title | Measurements |
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| - OG00054.23(47.26 to 60.68)
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| Secondary | Percentage of Participants With No Evidence of Disease Activity (Three Parameter [NEDA-3]) at Year 3 and at Year 4 | 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. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. An EDSS progression was defined as an increase of the EDSS score of at least 1.5 point compared to baseline for participants with a baseline EDSS of 0. For participants with an EDSS score between 0.5 and 4.5 at baseline (SD1), EDSS progression was defined as an increase of at least 1 point. For participants with baseline EDSS score of 5, EDSS progression was defined as an increase of at least 0.5. | The Full Analysis Set included all enrolled, eligible participants. | Posted | | Number | 95% Confidence Interval | percentage of participants | | At Year 3 and 4 after the initial dose of Mavenclad® tablets in parent study | | | | ID | Title | Description |
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| OG000 | Cladribine | Participants 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 parent 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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| Secondary | Percentage of Participants With No Evidence of Disease Activity (Three Parameter [NEDA-3]) After the Start of Study Medication During the Parent Study Until the End of Year 3 and Year 4 | 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. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. An EDSS progression was defined as an increase of the EDSS score of at least 1.5 point compared to baseline for participants with a baseline EDSS of 0. For participants with an EDSS score between 0.5 and 4.5 at baseline (SD1), EDSS progression was defined as an increase of at least 1 point. For participants with baseline EDSS score of 5, EDSS progression was defined as an increase of at least 0.5. | The Full Analysis Set included all enrolled, eligible participants. | Posted | | Number | 95% Confidence Interval | percentage of participants | | After the initial dose of Mavenclad® tablets in parent study until the end of Year 3 and 4 | | | | ID | Title | Description |
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| OG000 | Cladribine | Participants 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 parent 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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| Secondary | 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 | 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. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. An EDSS progression was defined as an increase of the EDSS score of at least 1.5 point compared to baseline for participants with a baseline EDSS of 0. For participants with an EDSS score between 0.5 and 4.5 at baseline (SD1), EDSS progression was defined as an increase of at least 1 point. For participants with baseline EDSS score of 5, EDSS progression was defined as an increase of at least 0.5. | The Full Analysis Set included all enrolled, eligible participants. Number of participants analyzed are number of participants evaluable at that time point in the outcome measure. | Posted | | Number | 95% Confidence Interval | percentage of participants | | At Year 3 and 4 after the initial dose of Mavenclad® tablets in parent study | | | | ID | Title | Description |
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| OG000 | Cladribine | Participants 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 parent 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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| Secondary | Time to First Disease Activity During Extension Study Period | 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. The 6MCDP during Extension Study Period is defined as sustained increase in EDSS score that started during the Period. Six-month CDP was considered. | The Full Analysis Set included all enrolled, eligible participants. | Posted | | Median | 95% Confidence Interval | months | | From Month 24 after the initial dose of Mavenclad tablets in parent study until the end of extension study (approximately 2 years) | | | | ID | Title | Description |
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| OG000 | Cladribine | Participants 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 parent 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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| Secondary | Time to First Disease Activity During up to Parent and Extension Study Period (4 Years) | 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. The 6MCDP during Extension Study Period is defined as sustained increase in EDSS score that started during the Period. Six-month CDP was considered. | The Full Analysis Set included all enrolled, eligible participants. | Posted | | Median | 95% Confidence Interval | months | | From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years) | | | | ID | Title | Description |
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| OG000 | Cladribine | Participants 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 parent 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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| Secondary | Time to First New or Enlarging T2 Lesion During Extension Study Period | Time taken for newly enlarging T2 lesions to show up is measured by follow-up MRI. | The Full Analysis Set included all enrolled, eligible participants. | Posted | | Median | 95% Confidence Interval | months | | From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years) | | | | ID | Title | Description |
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| OG000 | Cladribine | Participants 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 parent 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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| Secondary | Time to First New T1 Gadolinium Enhancing (Gd+) Lesion During Parent and Extension Study Period | Time taken for newly enlarging T1 Gadolinium Enhancing (Gd+) Lesion to show up is measured by follow-up MRI. Kaplan - Meier estimates were used for calculation of data. | The Full Analysis Set included all enrolled, eligible participants. | Posted | | Median | 95% Confidence Interval | months | | From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years) | | | | ID | Title | Description |
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| OG000 | Cladribine | Participants 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 parent 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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| Secondary | Time to First Confirmed Disability Progression (CDP) as Measured by Expanded Disability Status Scale (EDSS) During Parent and Extension Study Period | EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. An EDSS progression was defined as an increase of the EDSS score of at least 1.5 point compared to baseline for participants with a baseline EDSS of 0. For participants with an EDSS score between 0.5 and 4.5 at baseline (SD1), EDSS progression was defined as an increase of at least 1 point. For participants with baseline EDSS score of 5, EDSS progression was defined as an increase of at least 0.5. Kaplan - Meier estimates were used for calculation of data. | The Full Analysis Set included all enrolled, eligible participants. | Posted | | Median | 95% Confidence Interval | months | | From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years) | | | | ID | Title | Description |
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| OG000 | Cladribine | Participants 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 parent 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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| Secondary | Time to First Qualifying Relapse During Parent and Extension Study Period | 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. Kaplan - Meier estimates were used for calculation of data. | The Full Analysis Set included all enrolled, eligible participants. | Posted | | Median | 95% Confidence Interval | Months | | From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years) | | | | ID | Title | Description |
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| OG000 | Cladribine | Participants 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 parent 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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| Secondary | Time to Recurrent Qualifying Relapse During Parent and Extension Study Period | 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. Kaplan - Meier estimates were used for calculation of data. | The Full Analysis Set included all enrolled, eligible participants. | Posted | | Median | 95% Confidence Interval | months | | From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years) | | | | ID | Title | Description |
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| OG000 | Cladribine | Participants 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 parent 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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| Secondary | Time to Treatment Start With Other Disease Modifying Drugs (DMDs) During Parent and Extension Study Period | Time to Treatment Start with Other Disease Modifying Drugs (DMDs) During Parent and Extension Study Period. Kaplan - Meier estimates were used for calculation of data. | The Full Analysis Set included all enrolled, eligible participants. As per Protocol, in the parent study, a participant receiving any rescue medication with any other DMD would not participate further in any trial assessments and should have instead completed the early termination visit for final assessment hence no data was collected. | Posted | | | | | | From the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 4 years) | | | | ID | Title | Description |
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| OG000 | Cladribine | Participants 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 parent 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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| Secondary | Time to First New or Enlarging T2 Lesion During Extension Study Period | Time taken for newly enlarging T2 Gadolinium Enhancing (Gd+) Lesion to show up is measured by follow-up MRI. Kaplan - Meier estimates were used for calculation of data. | The Full Analysis Set included all enrolled, eligible participants. | Posted | | Median | 95% Confidence Interval | months | | From Month 24 after the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 2 years) | | | | ID | Title | Description |
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| OG000 | Cladribine | Participants 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 parent 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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| Secondary | Time to First New T1 Gadolinium Enhancing (Gd+) Lesion During Extension Study Period | Time taken for newly enlarging T1 Gadolinium Enhancing (Gd+) Lesion to show up is measured by follow-up MRI. Kaplan - Meier estimates were used for calculation of data. | The Full Analysis Set included all enrolled, eligible participants. | Posted | | Median | 95% Confidence Interval | months | | From Month 24 after the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 2 years) | | | | ID | Title | Description |
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| OG000 | Cladribine | Participants 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 parent 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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| Secondary | Time to First Confirmed Disability Progression (CDP) as Measured by Expanded Disability Status Scale (EDSS) During Extension Study Period | 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. | The Full Analysis Set included all enrolled, eligible participants. | Posted | | Median | 95% Confidence Interval | months | | From Month 24 after the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 2 years) | | | | ID | Title | Description |
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| OG000 | Cladribine | Participants 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 parent 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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| Secondary | Time to First Qualifying Relapse During Extension Study Period | 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. Kaplan - Meier estimates were used for calculation of data. | The Full Analysis Set included all enrolled, eligible participants. | Posted | | Median | 95% Confidence Interval | Months | | From Month 24 after the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 2 years) | | | | ID | Title | Description |
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| OG000 | Cladribine | Participants 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 parent 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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| Secondary | Time to Recurrent Qualifying Relapse During Extension Study Period | 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. | The Full Analysis Set included all enrolled, eligible participants. | Posted | | Median | 95% Confidence Interval | months | | From Month 24 after the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 2 years) | | | | ID | Title | Description |
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| OG000 | Cladribine | Participants 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 parent 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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| Secondary | Time to Treatment Start With Other Disease Modifying Drugs (DMDs) During Extension Study Period | Time to Treatment Start with Other Disease Modifying Drugs (DMDs) During Parent and Extension Study Period. Kaplan - Meier estimates were used for calculation of data. | The Full Analysis Set included all enrolled, eligible participants. As per Protocol, in the parent study, a participant receiving any rescue medication with any other DMD would not participate further in any trial assessments and should have instead completed the early termination visit for final assessment hence no data was collected. | Posted | | | | | | From Month 24 after the initial dose of Mavenclad® tablets in parent study until the end of extension study (approximately 2 years) | | | | ID | Title | Description |
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| OG000 | Cladribine | Participants 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 parent 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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| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | The Safety Analysis Set included all participants treated with at least one dose of cladribine tablets during the parent study. | Posted | | Count of Participants | | Participants | | From Month 24 after the initial dose of Mavenclad tablets in parent study until the end of extension study (approximately 2 years) | | | | ID | Title | Description |
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| OG000 | Cladribine | Participants 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 parent 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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