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

Completed

• Conditions: Relapsing-Remitting Multiple Sclerosis

• Registration Number: NCT05423769
• Lead Sponsor: Hikma Pharmaceuticals LLC

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 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 Timeline

• Study Start: 2022-01-19
• Study First Submitted: 2022-06-14
• Study First Submitted QC: 2022-06-14
• Study First Posted: 2022-06-21
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patients who initiate treatment with generic Fingolimod at baseline in accordance with the approved summary of product characteristics (SPC).

2. Males and females who are ≥ 18 years old.

3. Patients who had a diagnosis of RRMS per 2010 or 2017 revised McDonald criteria, who are:

   1. Newly diagnosed who had no prior Disease-Modifying Therapy (DMT), or
   2. Switched patients from Gilenya®, Novartis, or
   3. Switched patients from interferon beta (IFNβ).

4. Patients who agree to participate in the study and provide a written informed consent.

Exclusion Criteria

1. Pregnant or lactating female patients and women of childbearing potential not using effective contraception.
2. Patients lacking immunity against varicella zoster virus (VZV).
3. Patients participating in other clinical studies.
4. Patients who meet any of the contraindications to the administration of the study drug according to the approved SPC.

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).	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

Name	Time	Method
Proportion of patients with AEs and SAEs (including laboratory abnormalities) leading to treatment discontinuation.	up to 12 months from initiating generic Fingolimod.

Trial Locations

Locations (2)

Neuropsychiatry department, Faculty of Medicine, Alexandria University Hospitals, Hadra University Hospital; 🇪🇬 Alexandria, Egypt

Faculty of medicine Ain shams Research Institute-Clinical Research Center (MASRI-CRC); 🇪🇬 Cairo, Egypt