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Clinical trial

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

ID
Name
HIK-SPH-2021-01
Description
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
Trial arms
Trial start
2022-01-19
Estimated PCD
2023-11-30
Trial end
2024-05-01
Status
Active (not recruiting)
Treatment
Fingolimod
0.5 mg hard gelatine capsules
Other names:
Sphingomod®, Hikma
Size
30
Primary endpoint
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.
Eligibility criteria
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2024-03-05

1 organization

1 product

1 indication

Product
Fingolimod
Indication
Relapsing-Remitting Multiple Sclerosis
Organization
Hikma Pharmaceuticals