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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
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fingolimod | Drug | 0.5 mg hard gelatine capsules |
|
| 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. |
| 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. |
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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:
Patients who agree to participate in the study and provide a written informed consent.
Exclusion Criteria:
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Patients will be recruited from different sites in Egypt
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuropsychiatry department, Faculty of Medicine, Alexandria University Hospitals, Hadra University Hospital | Alexandria | Egypt | ||||
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D009461 | Neurologic Manifestations |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000068876 | Fingolimod Hydrochloride |
| ID | Term |
|---|---|
| D013110 | Sphingosine |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Faculty of medicine Ain shams Research Institute-Clinical Research Center (MASRI-CRC) |
| Cairo |
| Egypt |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011409 |
| Propylene Glycols |
| D006018 | Glycols |
| D000588 | Amines |