Clinical trial NCT05423769: Safety and Effectiveness of Generic Fingolimod (Sphingomod®, Hikma) in Patients With Relapsing-Remitting Multiple Sclerosis in Egypt
Official title: Safety and Effectiveness of Generic Fingolimod (Sphingomod®, Hikma) in Patients With Relapsing-Remitting Multiple Sclerosis in Egypt
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Hikma Pharmaceuticals LLC
Sponsor class: INDUSTRY
First posted: 2022-06-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from different sites in Egypt

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

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.

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.

Primary outcomes:
measure: Proportion of patients with AEs and SAEs (including laboratory abnormalities).
timeFrame: up to 12 months from initiating generic Fingolimod.
measure: Proportion of patients experiencing a relapse.
timeFrame: Time frame: up to 12 months period from initiating generic Fingolimod.
measure: Time to First Relapse (TTFR)
timeFrame: up to 12 months from initiating generic Fingolimod.
measure: Proportion of patients with disability progression as measured by the EDSS over time.
timeFrame: up to 12 months from initiating generic Fingolimod.
Secondary outcomes:
measure: Proportion of patients with AEs and SAEs (including laboratory abnormalities) leading to treatment discontinuation.
timeFrame: up to 12 months from initiating generic Fingolimod.
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Neuropsychiatry department, Faculty of Medicine, Alexandria University Hospitals, Hadra University Hospital
city: Cairo
country: Egypt
facility: Faculty of medicine Ain shams Research Institute-Clinical Research Center (MASRI-CRC)
Study officials:
References: