Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase
- Conditions
- Multiple Sclerosis
- Interventions
- Registration Number
- NCT00340834
- Lead Sponsor
- Novartis
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1292
- 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
- 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/exclusion criteria applied to the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fingolimod 1.25 mg Fingolimod 1.25 mg - Fingolimod 0.5 mg Fingolimod 0.5 mg - Interferon β-1a 30 µg Interferon β-1a 30 µg -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (143)
North Central Neurology Associates, PC, 1809 Kress Street
🇺🇸Cullman, Alabama, United States
Barrow Neurological Institute
🇺🇸Phoenix, Arizona, United States
The Neurology Center, 3907 Waring Road, Suite 3
🇺🇸Oceanside, California, United States
Associated Neurologists, PC, 69 Sand Pit Road, Suite 300
🇺🇸Danbury, Connecticut, United States
Associated Neurologists of Southern CT, PC, 75 Kings Highway Cutoff
🇺🇸Fairfield, Connecticut, United States
Yale University Multiple Sclerosis Center
🇺🇸New Haven, Connecticut, United States
University of Florida Health Science Center
🇺🇸Jacksonville, Florida, United States
Neurology Associates, PA, 301 N. Maitland Avenue, Suite A1
🇺🇸Maitland, Florida, United States
University of Miami, Department of Neurology
🇺🇸Miami, Florida, United States
Neurological Associates
🇺🇸Pompano Beach, Florida, United States
Scroll for more (133 remaining)North Central Neurology Associates, PC, 1809 Kress Street🇺🇸Cullman, Alabama, United States