Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-01-04 @ 5:34 PM
Study NCT ID:
NCT05423769
Status:
COMPLETED
Last Update Posted:
2024-08-23
First Post:
2022-06-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Effectiveness of Generic Fingolimod (Sphingomod®, Hikma) in Patients With Relapsing-Remitting Multiple Sclerosis in Egypt
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068876', 'term': 'Fingolimod Hydrochloride'}], 'ancestors': [{'id': 'D013110', 'term': 'Sphingosine'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011409', 'term': 'Propylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-22', 'studyFirstSubmitDate': '2022-06-14', 'studyFirstSubmitQcDate': '2022-06-14', 'lastUpdatePostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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.'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with AEs and SAEs (including laboratory abnormalities) leading to treatment discontinuation.', 'timeFrame': 'up to 12 months from initiating generic Fingolimod.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fingolimod', 'Generic Fingolimod', 'Nervous System', 'Multiple Sclerosis', 'Relapsing-Remitting Multiple Sclerosis', 'Cohort Study', 'Observational Study', 'Effectiveness', 'Safety', 'Disease Modifying Treatments'], 'conditions': ['Relapsing-Remitting Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be recruited from different sites in Egypt', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who initiate treatment with generic Fingolimod at baseline in accordance with the approved summary of product characteristics (SPC).\n2. Males and females who are ≥ 18 years old.\n3. Patients who had a diagnosis of RRMS per 2010 or 2017 revised McDonald criteria, who are:\n\n 1. Newly diagnosed who had no prior Disease-Modifying Therapy (DMT), or\n 2. Switched patients from Gilenya®, Novartis, or\n 3. Switched patients from interferon beta (IFNβ).\n4. Patients who agree to participate in the study and provide a written informed consent.\n\nExclusion Criteria:\n\n1. Pregnant or lactating female patients and women of childbearing potential not using effective contraception.\n2. Patients lacking immunity against varicella zoster virus (VZV).\n3. Patients participating in other clinical studies.\n4. Patients who meet any of the contraindications to the administration of the study drug according to the approved SPC.'}, 'identificationModule': {'nctId': 'NCT05423769', 'briefTitle': 'Safety and Effectiveness of Generic Fingolimod (Sphingomod®, Hikma) in Patients With Relapsing-Remitting Multiple Sclerosis in Egypt', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hikma Pharmaceuticals LLC'}, 'officialTitle': 'Safety and Effectiveness of Generic Fingolimod (Sphingomod®, Hikma) in Patients With Relapsing-Remitting Multiple Sclerosis in Egypt', 'orgStudyIdInfo': {'id': 'HIK-SPH-2021-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Fingolimod', 'type': 'DRUG', 'otherNames': ['Sphingomod®, Hikma'], 'description': '0.5 mg hard gelatine capsules'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Neuropsychiatry department, Faculty of Medicine, Alexandria University Hospitals, Hadra University Hospital', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of medicine Ain shams Research Institute-Clinical Research Center (MASRI-CRC)', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hikma Pharmaceuticals LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}