Status:
COMPLETED
Safety and Effectiveness of Generic Fingolimod (Sphingomod®, Hikma) in Patients With Relapsing-Remitting Multiple Sclerosis in Egypt
Lead Sponsor:
Hikma Pharmaceuticals LLC
Conditions:
Relapsing-Remitting Multiple Sclerosis
Eligibility:
All Genders
18+ years
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
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 car...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 19 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05423769
Start Date
January 19 2022
End Date
November 30 2023
Last Update
August 23 2024
Active Locations (2)
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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