Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis

Phase 3

Completed

Interventions: Drug: Fingolimod 1.25 mg
Drug: Fingolimod 0.5 mg
Drug: Placebo

Brief Summary: This study assessed the efficacy, safety, and tolerability of 2 doses of oral fingolimod (1.25 mg/day and 0.5 mg/day) compared to placebo in patients with relapsing-remitting multiple sclerosis (RRMS)

Recruitment & Eligibility

Inclusion Criteria

Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis
Patients with a relapsing-remitting disease course
Patients with 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

Other protocol-defined inclusion/exclusion criteria applied to this study.

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Estimated Annualized Aggregate Relapse Rate (ARR)	Baseline to end of study (Month 24)	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 the mean of the annualized ARRs for all patients in the group calculated as the total number of confirmed relapses divided by the total number of days on study, multiplied by 365.25.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients Free of Disability Progression at Month 24 Assessed With the Expanded Disability Status Scale (EDSS)	Baseline to end of study (Month 24)	EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the following: 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. A 3-month confirmed disability progression required onset EDSS, 3-month confirming EDSS, and all EDSS in between to meet the disability progression criteria. Percent of free of disability progression was calculated using the Kaplan Meier method.
Number of New or Newly Enlarged T2 Lesions at Month 24 in Comparison With Baseline	Baseline to end of study (Month 24)	The number of new or newly enlarged T2 lesions at Month 24 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.

Locations (98): The Queen Elizabeth Hospital
🇦🇺
Woodville South, South Australia, Australia
North Gosford Private Hospital
🇦🇺
Burrabil Avenue, Suite 17, Gosford, Australia
Strategic Health Evaluators
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Chatswood, Australia
St Vincent's Hospital Melbourne, Department of Clinical Neurosciences
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Fitzroy, Australia
Austin Health, Department of Neurology
🇦🇺
Heidelberg, Australia
Algemeen Ziekenhuis St. Jan, Department of Neurology
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Ruddershove 10, Brugge, Belgium
Erasme Hospital
🇧🇪
Route de Lennik 808, Brussels, Belgium
CHU Charleroi, Hôpital Civil
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Boulevard Paul Janson 92, Charleroi, Belgium
University Hospital Gasthuisberg
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Department Neurology, Herestraat 49, Leuven, Belgium
AZ Alma
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Department of Neurology & Rehab-Umit, Gentsesteenweg 132, Sijsele, Belgium
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The Queen Elizabeth Hospital
🇦🇺Woodville South, South Australia, Australia