Safety and Effectiveness of Generic Fingolimod (Sphingomod®, Hikma) in Patients With Relapsing-Remitting Multiple Sclerosis in Egypt

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Safety and Effectiveness of Generic Fingolimod (Sphingomod®, Hikma) in Patients With Relapsing-Remitting Multiple Sclerosis in Egypt

Conditions
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Relapsing-Remitting Multiple Sclerosis

Intervention / Treatment
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* Drug: Fingolimod


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who initiate treatment with generic Fingolimod at baseline in accordance with the approved summary of product characteristics (SPC). Males and females who are ≥ 18 years old. Patients who had a diagnosis of RRMS per 2010 or 2017 revised McDonald criteria, who are: Newly diagnosed who had no prior Disease-Modifying Therapy (DMT), or Switched patients from Gilenya®, Novartis, or Switched patients from interferon beta (IFNβ). Patients who agree to participate in the study and provide a written informed consent. Exclusion Criteria: Pregnant or lactating female patients and women of childbearing potential not using effective contraception. Patients lacking immunity against varicella zoster virus (VZV). Patients participating in other clinical studies. Patients who meet any of the contraindications to the administration of the study drug according to the approved SPC.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fingolimod|0.5 mg hard gelatine capsules|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with AEs and SAEs (including laboratory abnormalities). |  | up to 12 months from initiating generic Fingolimod. | 
| Proportion of patients experiencing a relapse. |  | Time frame: up to 12 months period from initiating generic Fingolimod. | 
| Time to First Relapse (TTFR) |  | up to 12 months from initiating generic Fingolimod. | 
| Proportion of patients with disability progression as measured by the EDSS over time. |  | up to 12 months from initiating generic Fingolimod. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with AEs and SAEs (including laboratory abnormalities) leading to treatment discontinuation. |  | up to 12 months from initiating generic Fingolimod. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, Fingolimod, Generic Fingolimod, Nervous System, Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis, Cohort Study, Observational Study, Effectiveness, Disease Modifying Treatments