Safety and Effectiveness of Generic Fingolimod (Sphingomod®, Hikma) in Patients With Relapsing-Remitting Multiple Sclerosis in Egypt
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Registration Number
- NCT05423769
- Lead Sponsor
- Hikma Pharmaceuticals LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. Patients who initiate treatment with generic Fingolimod at baseline in accordance<br> with the approved summary of product characteristics (SPC).<br><br> 2. Males and females who are = 18 years old.<br><br> 3. Patients who had a diagnosis of RRMS per 2010 or 2017 revised McDonald criteria, who<br> are:<br><br> 1. Newly diagnosed who had no prior Disease-Modifying Therapy (DMT), or<br><br> 2. Switched patients from Gilenya®, Novartis, or<br><br> 3. Switched patients from interferon beta (IFNß).<br><br> 4. Patients who agree to participate in the study and provide a written informed<br> consent.<br><br>Exclusion Criteria:<br><br> 1. Pregnant or lactating female patients and women of childbearing potential not using<br> effective contraception.<br><br> 2. Patients lacking immunity against varicella zoster virus (VZV).<br><br> 3. Patients participating in other clinical studies.<br><br> 4. Patients who meet any of the contraindications to the administration of the study<br> drug according to the approved SPC.
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with AEs and SAEs (including laboratory abnormalities).;Proportion of patients experiencing a relapse.;Time to First Relapse (TTFR);Proportion of patients with disability progression as measured by the EDSS over time.
- Secondary Outcome Measures
Name Time Method Proportion of patients with AEs and SAEs (including laboratory abnormalities) leading to treatment discontinuation.