Relapsing-Remitting Multiple SclerosisNCT05423769
Safety and Effectiveness of Generic Fingolimod (Sphingomod®, Hikma) in Patients With Relapsing-Remitting Multiple Sclerosis in Egypt
An observational study of Relapsing-Remitting Multiple Sclerosis, run by Hikma Pharmaceuticals LLC at 2 sites in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsing-Remitting Multiple Sclerosis
- What is being tested?
- Fingolimod
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- 19 Jan 2022to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from different sites in Egypt
Who may be able to join
- Patients who initiate treatment with generic Fingolimod at baseline in accordance with the approved summary of product characteristics (SPC).
- Males and females who are ≥ 18 years old.
- Patients who had a diagnosis of RRMS per 2010 or 2017 revised McDonald criteria, who are:
- Newly diagnosed who had no prior Disease-Modifying Therapy (DMT), or
- Switched patients from Gilenya®, Novartis, or
- Switched patients from interferon beta (IFNβ).
- Patients who agree to participate in the study and provide a written informed consent.
Who cannot join
- Pregnant or lactating female patients and women of childbearing potential not using effective contraception.
- Patients lacking immunity against varicella zoster virus (VZV).
- Patients participating in other clinical studies.
- Patients who meet any of the contraindications to the administration of the study drug according to the approved SPC.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Neuropsychiatry department, Faculty of Medicine, Alexandria University Hospitals, Hadra University Hospital
Alexandria
Faculty of medicine Ain shams Research Institute-Clinical Research Center (MASRI-CRC)
Cairo
About this study
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
Read the 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.
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Being tested
- Fingolimod
- Keywords
- Fingolimod, Generic Fingolimod, Nervous System, Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis, Cohort Study, Observational Study, Effectiveness, Safety, Disease Modifying Treatments
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Neurologic Manifestations, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FingolimodDrug
Also called Sphingomod®, Hikma
0.5 mg hard gelatine capsules
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with AEs and SAEs (including laboratory abnormalities).
Measured: up to 12 months from initiating generic Fingolimod.
Proportion of patients experiencing a relapse.
Measured: Time frame: up to 12 months period from initiating generic Fingolimod.
Time to First Relapse (TTFR)
Measured: up to 12 months from initiating generic Fingolimod.
Proportion of patients with disability progression as measured by the EDSS over time.
Measured: up to 12 months from initiating generic Fingolimod.
Secondary outcomes (1)
Proportion of patients with AEs and SAEs (including laboratory abnormalities) leading to treatment discontinuation.
Measured: up to 12 months from initiating generic Fingolimod.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start19 Jan 2022
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing-Remitting Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hikma Pharmaceuticals LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423769
- Sponsor's protocol ID
- HIK-SPH-2021-01
- Status last verified
- Mar 2024
- First submitted
- 14 Jun 2022
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Generic Fingolimod (Sphingomod®, Hikma) in Patients With Relapsing-Remitting Multiple Sclerosis in Egypt
- ClinicalTrials.gov ID
- NCT05423769
- Acronym / sponsor ID
- HIK-SPH-2021-01
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Keywords
- Fingolimod, Generic Fingolimod, Nervous System, Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis, Cohort Study, Observational Study, Effectiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hikma Pharmaceuticals LLCIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from different sites in Egypt
Key inclusion criteria (7 listed)
- Patients who initiate treatment with generic Fingolimod at baseline in accordance with the approved summary of product characteristics (SPC).
- Males and females who are ≥ 18 years old.
- Patients who had a diagnosis of RRMS per 2010 or 2017 revised McDonald criteria, who are:
- Patients who agree to participate in the study and provide a written informed consent.
Key exclusion criteria (4 listed)
- Pregnant or lactating female patients and women of childbearing potential not using effective contraception.
- Patients lacking immunity against varicella zoster virus (VZV).
- Patients participating in other clinical studies.
- Patients who meet any of the contraindications to the administration of the study drug according to the approved SPC.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FingolimodAlso: Sphingomod®, Hikma0.5 mg hard gelatine capsules | Drug | – |
Primary outcome
Proportion of patients with AEs and SAEs (including laboratory abnormalities).
Time frame: 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 to First Relapse (TTFR)
Time frame: 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.
1 secondary outcome
Proportion of patients with AEs and SAEs (including laboratory abnormalities) leading to treatment discontinuation.
Time frame: up to 12 months from initiating generic Fingolimod.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing-Remitting Multiple Sclerosis, run by Hikma Pharmaceuticals LLC at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with AEs and SAEs (including laboratory abnormalities). (time frame: up to 12 months from initiating generic Fingolimod.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.