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

August 22, 2024 updated by: Hikma Pharmaceuticals LLC
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Neuropsychiatry department, Faculty of Medicine, Alexandria University Hospitals, Hadra University Hospital
      • Cairo, Egypt
        • Faculty of medicine Ain shams Research Institute-Clinical Research Center (MASRI-CRC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients will be recruited from different sites in Egypt

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with AEs and SAEs (including laboratory abnormalities).
Time Frame: up to 12 months from initiating generic Fingolimod.
up to 12 months from initiating generic Fingolimod.
Proportion of patients experiencing a relapse.
Time Frame: Time frame: up to 12 months period from initiating generic Fingolimod.
Time frame: up to 12 months period from initiating generic Fingolimod.
Time to First Relapse (TTFR)
Time Frame: up to 12 months from initiating generic Fingolimod.
up to 12 months from initiating generic Fingolimod.
Proportion of patients with disability progression as measured by the EDSS over time.
Time Frame: up to 12 months from initiating generic Fingolimod.
up to 12 months from initiating generic Fingolimod.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hikma Pharmaceuticals LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2022

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

November 30, 2023

Study Registration Dates

First Submitted

June 14, 2022

First Submitted That Met QC Criteria

June 14, 2022

First Posted (Actual)

June 21, 2022

Study Record Updates

Last Update Posted (Actual)

August 23, 2024

Last Update Submitted That Met QC Criteria

August 22, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIK-SPH-2021-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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