This 4 month, open-label study will evaluate the safety and tolerability of fingolimod 0.5 mg in patients with relapsing-remitting multiple sclerosis (RRMS) and generate additional data in Multiple Sclerosis (MS) patient population that closely resembles the clinical population seen in routine medical care.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
162
Fingolimod will be supplied as 0.5mg capsules in bottles of 35.
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity
Time frame: 28 weeks
Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema.
The incidence of events in special areas of safety interest (including bradyarrhythmias, BP increase, liver function, infections and macular oedema) were assessed by the nature and frequency of AE reporting. These areas of special interest have been identified and potential risks of fingolimod based on knowledge from clinical trials and post-marketing reporting.
Time frame: 4 months
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Novartis Investigative Site
Caba, Buenos Aires, Argentina
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Villa Nueva, Mendoza Province, Argentina
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Salta, Salta Province, Argentina
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Salta, Salta Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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Córdoba, Argentina
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Rio de Janeiro, Rio de Janeiro, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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