Multiple Sclerosis
Conditions
Keywords
FTY720, Interferon, RRMS, Multiple Sclerosis, Efficacy
Brief summary
This study assessed the safety, tolerability, and efficacy of 2 doses of oral fingolimod versus interferon β-1a to reduce the frequency of relapses in patients with relapsing-remitting multiple sclerosis.
Interventions
Core: Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly. Extension: Patients self-administered fingolimod 1.25 mg capsules orally once daily until switched to 0.5 mg capsules upon study protocol amendment.
Core: Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly. Extension: Patients self-administered fingolimod 0.5 mg capsules orally once daily.
DRUGInterferon β-1a 30 µg
Core: Patients self-administered interferon β-1a 30 μg in an intramuscular (im) injection once weekly. In addition, they self-administered a fingolimod placebo capsule orally once daily. Extension: Patients self-administered either fingolimod 1.25 mg or 0.5 mg capsules orally once daily until switched to 0.5 mg capsules upon study protocol amendment.
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis (MS) * Patients with a relapsing-remitting disease course * Patients with Expanded Disability Status Scale (EDSS) score of 0-5.5
Exclusion criteria
* Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc * Pregnant or nursing women * Patients who cannot tolerate treatment with an interferon Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study | Baseline to Month 12 | The ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was calculated using negative binomial regression adjusted by treatment, country, number of relapses in the previous 2 years, and the baseline Expanded Disability Status Scale score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of New or Newly Enlarged T2 Lesions in Comparison With Baseline in the Core Phase of the Study | Baseline to Month 12 | The number of new or newly enlarged T2 lesions in comparison to baseline was assessed with T2-weighted magnetic resonance image (MRI) scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2-weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis. |
| Percentage of Participants Free of 3-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Core Phase of the Study | Baseline to Month 12 | The EDSS is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel & bladder, cerebral, other functions). An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the EDSS score based on the following criteria: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. Percent of patients free of disability progression was calculated using the Kaplan-Meier method. |
| Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study | Month 0 to end of study (up to approximately 4.5 years) | The ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was calculated using negative binomial regression adjusted by treatment, country, number of relapses in the previous 2 years, and the baseline Expanded Disability Status Scale score. |
| Number of New or Newly Enlarged T2 Lesions in the Extension Phase of the Study | Month 12 to end of study (up to approximately 3.5 years) | The number of new or newly enlarged T2 lesions in comparison to baseline was assessed with T2-weighted magnetic resonance image (MRI) scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2-weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis. |
| Percentage of Participants Free of 3-month and 6-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Extension Phase of the Study | Baseline to end of study (up to approximately 4.5 years) | The EDSS is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel & bladder, cerebral, other functions). An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the EDSS score based on the following criteria: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. Percent of patients free of disability progression was calculated using the Kaplan-Meier method. |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Egypt, France, Germany, Greece, Hungary, Italy, Portugal, South Korea, Spain, Switzerland, United Kingdom, United States
Participant flow
Recruitment details
Patients randomized in the Core Phase (CP) to receive 0.5 mg or 1.25 mg fingolimod received the same dose in the Extension Phase (EP). Patients randomized to receive interferon-β-1a in the CP were re-randomized to receive either 0.5 mg or 1.25 mg fingolimod in a 1:1 ratio in the EP. Upon protocol amendment, all patients received 0.5 mg fingolimod.
Participants by arm
| Arm | Count |
|---|---|
| Fingolimod 1.25 mg Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly. | 426 |
| Fingolimod 0.5 mg Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly. | 431 |
| Interferon β-1a 30 µg Patients self-administered interferon β-1a 30 μg in an intramuscular (im) injection once weekly. In addition, they self-administered a fingolimod placebo capsule orally once daily. | 435 |
| Interferon β-1a/Fingolimod 1.25 mg Patients who received Interferon β-1a 30 µg in the core phase of the study were randomized to receive self-administered fingolimod 1.25 mg capsules orally once daily. | 174 |
| Interferon β-1a/Fingolimod 0.5 mg Patients who received Interferon β-1a 30 µg in the core phase of the study were randomized to receive self-administered fingolimod 0.5 mg capsules orally once daily. | 167 |
| Total | 1,633 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Core Phase of Study | Abnormal laboratory value(s) | 4 | 6 | 1 | 0 | 0 |
| Core Phase of Study | Abnormal test procedure result(s) | 4 | 3 | 3 | 0 | 0 |
| Core Phase of Study | Administrative Problems | 6 | 2 | 7 | 0 | 0 |
| Core Phase of Study | Adverse Event | 26 | 9 | 9 | 0 | 0 |
| Core Phase of Study | Death | 2 | 0 | 0 | 0 | 0 |
| Core Phase of Study | Lack of Efficacy | 3 | 3 | 7 | 0 | 0 |
| Core Phase of Study | Lost to Follow-up | 1 | 1 | 4 | 0 | 0 |
| Core Phase of Study | Protocol Violation | 0 | 0 | 2 | 0 | 0 |
| Core Phase of Study | Withdrawal by Subject | 11 | 9 | 16 | 0 | 0 |
| Extension Phase of Study | Abnormal laboratory value(s) | 14 | 13 | 0 | 13 | 4 |
| Extension Phase of Study | Abnormal test procedure result(s) | 0 | 1 | 0 | 0 | 2 |
| Extension Phase of Study | Administrative problems | 3 | 0 | 0 | 1 | 1 |
| Extension Phase of Study | Adverse Event | 21 | 22 | 0 | 19 | 7 |
| Extension Phase of Study | Death | 0 | 0 | 0 | 0 | 1 |
| Extension Phase of Study | Lost to Follow-up | 1 | 1 | 0 | 2 | 3 |
| Extension Phase of Study | Protocol Violation | 3 | 0 | 0 | 0 | 0 |
| Extension Phase of Study | Subject did not receive study drug | 0 | 1 | 0 | 2 | 0 |
| Extension Phase of Study | Subject no longer requires study drug | 4 | 0 | 0 | 0 | 2 |
| Extension Phase of Study | Subject withdrew consent | 26 | 31 | 0 | 12 | 15 |
| Extension Phase of Study | Unsatisfactory therapeutic effect | 13 | 7 | 0 | 4 | 9 |
Baseline characteristics
| Characteristic | Fingolimod 1.25 mg | Fingolimod 0.5 mg | Interferon β-1a 30 µg | Interferon β-1a/Fingolimod 1.25 mg | Interferon β-1a/Fingolimod 0.5 mg | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 35.5 Years STANDARD_DEVIATION 8.42 | 36.5 Years STANDARD_DEVIATION 8.67 | NA Years | 36.1 Years STANDARD_DEVIATION 8.11 | 36.1 Years STANDARD_DEVIATION 8.59 | 36.0 Years STANDARD_DEVIATION 8.48 |
| Age, Customized < 18 | 0 Participants | 0 Participants | 0 Participants | NA Participants | NA Participants | 0 Participants |
| Age, Customized 18-30 | 100 Participants | 117 Participants | 113 Participants | NA Participants | NA Participants | 355 Participants |
| Age, Customized 31-40 | 122 Participants | 150 Participants | 185 Participants | NA Participants | NA Participants | 394 Participants |
| Age, Customized 41-55 | 141 Participants | 131 Participants | NA Participants | 52 Participants | 57 Participants | 348 Participants |
| Age, Customized >55 | 0 Participants | 0 Participants | NA Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized > 55 | 0 Participants | 0 Participants | 0 Participants | NA Participants | NA Participants | 0 Participants |
| Sex: Female, Male Female | 293 Participants | 282 Participants | 295 Participants | NA Participants | NA Participants | NA Participants |
| Sex: Female, Male Male | 133 Participants | 149 Participants | 140 Participants | NA Participants | NA Participants | NA Participants |
| Sex/Gender, Customized Female | 227 Participants | 235 Participants | NA Participants | 114 Participants | 109 Participants | 685 Participants |
| Sex/Gender, Customized Male | 103 Participants | 121 Participants | NA Participants | 60 Participants | 58 Participants | 342 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 310 / 420 | 302 / 429 | 359 / 431 | 446 / 504 | 439 / 523 |
| serious Total, serious adverse events | 45 / 420 | 30 / 429 | 25 / 431 | 77 / 504 | 76 / 523 |
Outcome results
Primary
Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study
The ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was calculated using negative binomial regression adjusted by treatment, country, number of relapses in the previous 2 years, and the baseline Expanded Disability Status Scale score.
Time frame: Baseline to Month 12
Population: Intent-to-treat population (ITT): All patients who were randomized and received at least 1 dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fingolimod 1.25 mg | Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study | 0.203 Estimate relapses per year |
| Fingolimod 0.5 mg | Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study | 0.161 Estimate relapses per year |
| Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg | Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study | 0.331 Estimate relapses per year |
Secondary
Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study
The ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was calculated using negative binomial regression adjusted by treatment, country, number of relapses in the previous 2 years, and the baseline Expanded Disability Status Scale score.
Time frame: Month 0 to end of study (up to approximately 4.5 years)
Population: Intent-to-treat population (ITT): All patients who were randomized and received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fingolimod 1.25 mg | Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study | Month 12 to Month 24, n=330, 356, 341 | 0.156 Estimated relapses per year |
| Fingolimod 1.25 mg | Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study | Month 48 to end of study, n=36, 38, 29 | NA Estimated relapses per year |
| Fingolimod 1.25 mg | Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study | Month 36 to Month 48, n=267, 303, 271 | NA Estimated relapses per year |
| Fingolimod 1.25 mg | Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study | Month 0 to end of study, n=420, 429, 431 | 0.192 Estimated relapses per year |
| Fingolimod 1.25 mg | Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study | Month 24 to Month 36, n=287, 321, 293 | 0.116 Estimated relapses per year |
| Fingolimod 0.5 mg | Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study | Month 36 to Month 48, n=267, 303, 271 | NA Estimated relapses per year |
| Fingolimod 0.5 mg | Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study | Month 12 to Month 24, n=330, 356, 341 | 0.182 Estimated relapses per year |
| Fingolimod 0.5 mg | Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study | Month 24 to Month 36, n=287, 321, 293 | 0.110 Estimated relapses per year |
| Fingolimod 0.5 mg | Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study | Month 48 to end of study, n=36, 38, 29 | NA Estimated relapses per year |
| Fingolimod 0.5 mg | Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study | Month 0 to end of study, n=420, 429, 431 | 0.166 Estimated relapses per year |
| Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg | Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study | Month 0 to end of study, n=420, 429, 431 | 0.271 Estimated relapses per year |
| Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg | Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study | Month 48 to end of study, n=36, 38, 29 | NA Estimated relapses per year |
| Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg | Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study | Month 12 to Month 24, n=330, 356, 341 | 0.266 Estimated relapses per year |
| Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg | Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study | Month 36 to Month 48, n=267, 303, 271 | NA Estimated relapses per year |
| Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg | Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study | Month 24 to Month 36, n=287, 321, 293 | 0.121 Estimated relapses per year |
Secondary
Number of New or Newly Enlarged T2 Lesions in Comparison With Baseline in the Core Phase of the Study
The number of new or newly enlarged T2 lesions in comparison to baseline was assessed with T2-weighted magnetic resonance image (MRI) scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2-weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.
Time frame: Baseline to Month 12
Population: Intent-to-treat population (ITT): All randomized patients who received at least 1 dose of study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fingolimod 1.25 mg | Number of New or Newly Enlarged T2 Lesions in Comparison With Baseline in the Core Phase of the Study | 1.6 T2 lesions | Standard Deviation 3.23 |
| Fingolimod 0.5 mg | Number of New or Newly Enlarged T2 Lesions in Comparison With Baseline in the Core Phase of the Study | 1.6 T2 lesions | Standard Deviation 3.16 |
| Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg | Number of New or Newly Enlarged T2 Lesions in Comparison With Baseline in the Core Phase of the Study | 2.6 T2 lesions | Standard Deviation 5.5 |
Secondary
Number of New or Newly Enlarged T2 Lesions in the Extension Phase of the Study
The number of new or newly enlarged T2 lesions in comparison to baseline was assessed with T2-weighted magnetic resonance image (MRI) scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2-weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.
Time frame: Month 12 to end of study (up to approximately 3.5 years)
Population: Intent-to-treat population (ITT): All randomized patients who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fingolimod 1.25 mg | Number of New or Newly Enlarged T2 Lesions in the Extension Phase of the Study | Month 36 to Month 48, n=36, 34, 35 | 0.97 T2 lesions | Standard Deviation 1.682 |
| Fingolimod 1.25 mg | Number of New or Newly Enlarged T2 Lesions in the Extension Phase of the Study | Month 12 to Month 24 | 1.08 T2 lesions | Standard Deviation 2.644 |
| Fingolimod 1.25 mg | Number of New or Newly Enlarged T2 Lesions in the Extension Phase of the Study | Last MRI scan to end of study, n=275, 309, 290 | 1.75 T2 lesions | Standard Deviation 7.248 |
| Fingolimod 1.25 mg | Number of New or Newly Enlarged T2 Lesions in the Extension Phase of the Study | Month 24 to Month 36, n=255, 289, 258 | 1.40 T2 lesions | Standard Deviation 3.418 |
| Fingolimod 0.5 mg | Number of New or Newly Enlarged T2 Lesions in the Extension Phase of the Study | Month 36 to Month 48, n=36, 34, 35 | 0.59 T2 lesions | Standard Deviation 1.438 |
| Fingolimod 0.5 mg | Number of New or Newly Enlarged T2 Lesions in the Extension Phase of the Study | Month 24 to Month 36, n=255, 289, 258 | 1.04 T2 lesions | Standard Deviation 4.408 |
| Fingolimod 0.5 mg | Number of New or Newly Enlarged T2 Lesions in the Extension Phase of the Study | Last MRI scan to end of study, n=275, 309, 290 | 0.86 T2 lesions | Standard Deviation 2.674 |
| Fingolimod 0.5 mg | Number of New or Newly Enlarged T2 Lesions in the Extension Phase of the Study | Month 12 to Month 24 | 0.87 T2 lesions | Standard Deviation 1.624 |
| Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg | Number of New or Newly Enlarged T2 Lesions in the Extension Phase of the Study | Last MRI scan to end of study, n=275, 309, 290 | 1.03 T2 lesions | Standard Deviation 4.35 |
| Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg | Number of New or Newly Enlarged T2 Lesions in the Extension Phase of the Study | Month 12 to Month 24 | 0.97 T2 lesions | Standard Deviation 1.923 |
| Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg | Number of New or Newly Enlarged T2 Lesions in the Extension Phase of the Study | Month 24 to Month 36, n=255, 289, 258 | 0.72 T2 lesions | Standard Deviation 1.733 |
| Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg | Number of New or Newly Enlarged T2 Lesions in the Extension Phase of the Study | Month 36 to Month 48, n=36, 34, 35 | 0.49 T2 lesions | Standard Deviation 1.483 |
Secondary
Percentage of Participants Free of 3-month and 6-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Extension Phase of the Study
The EDSS is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel & bladder, cerebral, other functions). An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the EDSS score based on the following criteria: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. Percent of patients free of disability progression was calculated using the Kaplan-Meier method.
Time frame: Baseline to end of study (up to approximately 4.5 years)
Population: Intent-to-treat population (ITT): All randomized patients who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fingolimod 1.25 mg | Percentage of Participants Free of 3-month and 6-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Extension Phase of the Study | Free of 3-month progression | 67.01 Percentage of participants |
| Fingolimod 1.25 mg | Percentage of Participants Free of 3-month and 6-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Extension Phase of the Study | Free of 6-month progression | 79.54 Percentage of participants |
| Fingolimod 0.5 mg | Percentage of Participants Free of 3-month and 6-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Extension Phase of the Study | Free of 3-month progression | 71.28 Percentage of participants |
| Fingolimod 0.5 mg | Percentage of Participants Free of 3-month and 6-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Extension Phase of the Study | Free of 6-month progression | 79.76 Percentage of participants |
| Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg | Percentage of Participants Free of 3-month and 6-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Extension Phase of the Study | Free of 6-month progression | 81.61 Percentage of participants |
| Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg | Percentage of Participants Free of 3-month and 6-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Extension Phase of the Study | Free of 3-month progression | 73.40 Percentage of participants |
Secondary
Percentage of Participants Free of 3-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Core Phase of the Study
The EDSS is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel & bladder, cerebral, other functions). An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the EDSS score based on the following criteria: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. Percent of patients free of disability progression was calculated using the Kaplan-Meier method.
Time frame: Baseline to Month 12
Population: Intent-to-treat population (ITT): All randomized patients who received at least 1 dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fingolimod 1.25 mg | Percentage of Participants Free of 3-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Core Phase of the Study | 93.3 Percentage of participants |
| Fingolimod 0.5 mg | Percentage of Participants Free of 3-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Core Phase of the Study | 94.1 Percentage of participants |
| Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg | Percentage of Participants Free of 3-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Core Phase of the Study | 92.1 Percentage of participants |