Safety and Effectiveness of Generic Fingolimod (Sphingomod®, Hikma) in Patients With Relapsing-Remitting Multiple Sclerosis in Egypt
We could not find results for this trial
I know where the results areWhat it found
We found no results in the registry or in papers.
This trial finished 2 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
What it measured
Main measures
Proportion of patients with AEs and SAEs (including laboratory abnormalities).
up to 12 months from initiating generic Fingolimod.
SafetyProportion of patients experiencing a relapse.
Time frame: up to 12 months period from initiating generic Fingolimod.
RelapsesTime to First Relapse (TTFR)
up to 12 months from initiating generic Fingolimod.
RelapsesProportion of patients with disability progression as measured by the EDSS over time.
up to 12 months from initiating generic Fingolimod.
Disability progression
Other measures (1)
Proportion of patients with AEs and SAEs (including laboratory abnormalities) leading to treatment discontinuation.
up to 12 months from initiating generic Fingolimod.
Safety
Who could take part
Relapsing MS · 18 and over
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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
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History
Started
Jan 2022
Main results due
Nov 2023
Finished
Nov 2023
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