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

NCT05423769 | Completed

• 1 other identifier: HIK-SPH-2021-01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

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

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Proportion of patients with AEs and SAEs (including laboratory abnormalities) leading to treatment discontinuation.

  up to 12 months from initiating generic Fingolimod.

Interventions

Fingolimod DRUG

0.5 mg hard gelatine capsules

Also known as: Sphingomod®, Hikma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from different sites in Egypt

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hikma Pharmaceuticals LLC: lead

Study Sites (2)

Neuropsychiatry department, Faculty of Medicine, Alexandria University Hospitals, Hadra University Hospital

Alexandria, Egypt

Location

Faculty of medicine Ain shams Research Institute-Clinical Research Center (MASRI-CRC)

Cairo, Egypt

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Neurologic Manifestations; Multiple Sclerosis

Interventions

Fingolimod Hydrochloride

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sphingosine; Amino Alcohols; Alcohols; Organic Chemicals; Propylene Glycols; Glycols; Amines

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 21, 2022
• Study Start: January 19, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: August 23, 2024

Record last verified: 2024-03

Locations

EG (2)