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

Hikma

Status: Completed

Conditions: Relapsing-Remitting Multiple Sclerosis

Treatments: Drug: Fingolimod

Study type: Observational

Funder types: Industry

Identifiers

NCT05423769

HIK-SPH-2021-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.