The purpose of this observational study is to evaluate the Safety and Effectiveness of Generic Fingolimod (Sphingomod®, Hikma) in Patients with Relapsing-Remitting Multiple Sclerosis in Egypt
This is an observational, prospective, cohort study, where no visits or intervention(s) additional to the daily practice will be performed. In the study sites, patients undergoing routine clinical care for RRMS and initiating treatment with generic Fingolimod in accordance with the approved summary of product characteristics (SPC) will be followed up and assessed for a total of 12 months.
Study Type
OBSERVATIONAL
Enrollment
30
0.5 mg hard gelatine capsules
Neuropsychiatry department, Faculty of Medicine, Alexandria University Hospitals, Hadra University Hospital
Alexandria, Egypt
Faculty of medicine Ain shams Research Institute-Clinical Research Center (MASRI-CRC)
Cairo, Egypt
Proportion of patients with AEs and SAEs (including laboratory abnormalities).
Time frame: up to 12 months from initiating generic Fingolimod.
Proportion of patients experiencing a relapse.
Time frame: Time frame: up to 12 months period from initiating generic Fingolimod.
Time to First Relapse (TTFR)
Time frame: up to 12 months from initiating generic Fingolimod.
Proportion of patients with disability progression as measured by the EDSS over time.
Time frame: up to 12 months from initiating generic Fingolimod.
Proportion of patients with AEs and SAEs (including laboratory abnormalities) leading to treatment discontinuation.
Time frame: up to 12 months from initiating generic Fingolimod.
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