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

Relapsing-Remitting Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05423769
• Other study ID #: HIK-SPH-2021-01
• Status: Active, not recruiting
• Start date: January 19, 2022
• Est. completion date: May 2024

Study information

• Verified date: March 2024
• Source: Hikma Pharmaceuticals LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: May 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (IFNß).

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-Remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Fingolimod
0.5 mg hard gelatine capsules

Locations

Country	Name	City	State
Egypt	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

Sponsors (1)

Lead Sponsor	Collaborator
Hikma Pharmaceuticals LLC

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with AEs and SAEs (including laboratory abnormalities).		up to 12 months from initiating generic Fingolimod.
Primary	Proportion of patients experiencing a relapse.		Time frame: up to 12 months period from initiating generic Fingolimod.
Primary	Time to First Relapse (TTFR)		up to 12 months from initiating generic Fingolimod.
Primary	Proportion of patients with disability progression as measured by the EDSS over time.		up to 12 months from initiating generic Fingolimod.
Secondary	Proportion of patients with AEs and SAEs (including laboratory abnormalities) leading to treatment discontinuation.		up to 12 months from initiating generic Fingolimod.