Safety and Effectiveness of Generic Fingolimod (Sphingomod®, Hikma) in Patients With Relapsing-Remitting Multiple Sclerosis in Egypt
Study Details
Study Description
Brief Summary
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
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
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 Design
Outcome Measures
Primary Outcome Measures
- 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
- Proportion of patients with AEs and SAEs (including laboratory abnormalities) leading to treatment discontinuation. [up to 12 months from initiating generic Fingolimod.]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients who initiate treatment with generic Fingolimod at baseline in accordance with the approved summary of product characteristics (SPC).
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Males and females who are ≥ 18 years old.
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Patients who had a diagnosis of RRMS per 2010 or 2017 revised McDonald criteria, who are:
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Newly diagnosed who had no prior Disease-Modifying Therapy (DMT), or
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Switched patients from Gilenya®, Novartis, or
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Switched patients from interferon beta (IFNβ).
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Patients who agree to participate in the study and provide a written informed consent.
Exclusion Criteria:
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Pregnant or lactating female patients and women of childbearing potential not using effective contraception.
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Patients lacking immunity against varicella zoster virus (VZV).
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Patients participating in other clinical studies.
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Patients who meet any of the contraindications to the administration of the study drug according to the approved SPC.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Neuropsychiatry department, Faculty of Medicine, Alexandria University Hospitals, Hadra University Hospital | Alexandria | Egypt | ||
2 | Faculty of medicine Ain shams Research Institute-Clinical Research Center (MASRI-CRC) | Cairo | Egypt |
Sponsors and Collaborators
- Hikma Pharmaceuticals LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HIK-SPH-2021-01