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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05423769

Enrollment

Registered

2022-06-21

Start date

2022-01-19

Completion date

2023-11-30

Last updated

2024-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing-Remitting Multiple Sclerosis

Keywords

Fingolimod, Generic Fingolimod, Nervous System, Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis, Cohort Study, Observational Study, Effectiveness, Safety, Disease Modifying Treatments

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.

Interventions

DRUGFingolimod

0.5 mg hard gelatine capsules

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	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.

Secondary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026