Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2026-03-05 @ 12:07 AM
Study NCT ID:
NCT04593927
Status:
COMPLETED
Last Update Posted:
2024-02-12
First Post:
2020-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Term Special Drug Use-results Surveillance for Mayzent in SPMS Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020528', 'term': 'Multiple Sclerosis, Chronic Progressive'}], 'ancestors': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C578989', 'term': 'siponimod'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 451}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-09', 'studyFirstSubmitDate': '2020-10-14', 'studyFirstSubmitQcDate': '2020-10-14', 'lastUpdatePostDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Adverse Events (AE), Serious Adverse Events (SAE) and Adverse Reactions', 'timeFrame': '24 months', 'description': 'A SAE is defined as an AE whose description suggests that it is serious or whose outcome is fatal.\n\nAn adverse reaction is defined as an adverse event that is suspected by the investigator to be causally related to Mayzent or whose causality is not recorded'}], 'secondaryOutcomes': [{'measure': "Physician's Global Assessment (PGA) of disease activity", 'timeFrame': 'month 12 and month 24', 'description': 'Secondary Progressive Multiple Sclerosis (SPMS) symptom changes will be assessed an rated as "very much improved", "improved", "unchanged", "worsening" or "not assessable" in comparison with the symptoms at the start of Mayzent administration'}, {'measure': 'Changes over time in Expanded Disability Status Scale (EDSS) score', 'timeFrame': 'Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21 and month 24', 'description': 'EDSS assesses disability. An overall score ranging from 0 (normal) to 10 (death due to MS) will be calculated.'}, {'measure': 'Time to confirmed disability progression continuing for ≥ 3 months from the start of administration as assessed by the EDSS', 'timeFrame': '24 months', 'description': 'Disability progression is defined as an increase of 1.5 points or more in patients with an EDSS score of 0 at baseline, an increase of 1 point or more in patients with an EDSS score of 0.5 to 5 at baseline and an increase of 0.5 points or more in patients with an EDSS score of 5.5 or more at baseline.'}, {'measure': 'Time to confirmed disability progression continuing for ≥ 6 months from the start of administration as assessed by the EDSS', 'timeFrame': '24 months', 'description': 'Disability progression is defined as an increase of 1.5 points or more in patients with an EDSS score of 0 at baseline, an increase of 1 point or more in patients with an EDSS score of 0.5 to 5 at baseline and an increase of 0.5 points or more in patients with an EDSS score of 5.5 or more at baseline.'}, {'measure': 'Annual relapse rate', 'timeFrame': '24 months', 'description': 'Annual relapse rate will be calculated'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Secondary Progressive Multiple Sclerosis', 'SPMS', 'Mayzent', 'Siponimod', 'Japan'], 'conditions': ['Secondary Progressive Multiple Sclerosis (SPMS)']}, 'descriptionModule': {'briefSummary': 'This study is a single cohort, central registration system, all-case, open-label, multicenter observational study in patients using Mayzent for the indication of secondary progressive multiple sclerosis.', 'detailedDescription': 'This is a non-interventional study, and as such there is no binding treatment strategy, diagnosis/treatment procedures or visit schedule. The investigator should administer Mayzent as labelled. Routine medical practice will apply to visit frequency and evaluation variables, and only these data will be collected by the sponsor as part of the study procedures. The investigator should record data in the applicable CRFs at every visit if possible.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients using Mayzent for the following indication for a specified post-marketing period of time\n\n• Indication: prevention of relapses and delay of progression of physical disability in secondary progressive multiple sclerosis By allowing patients who started Mayzent administration before the conclusion of a contract for this study to be included in the study population after the contract, all patients treated with Mayzent will be enrolled in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients prescribed Mayzent for prevention of relapses and delay of progression of physical disability in secondary progressive multiple sclerosis\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04593927', 'briefTitle': 'Long Term Special Drug Use-results Surveillance for Mayzent in SPMS Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Long Term Special Drug Use-results Surveillance for Mayzent in SPMS Patients (Prevention of Relapses and Delay of Progression of Physical Disability in Secondary Progressive Multiple Sclerosis)', 'orgStudyIdInfo': {'id': 'CBAF312A1401'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mayzent', 'description': 'Patients administered Mayzent by prescription', 'interventionNames': ['Drug: Mayzent']}], 'interventions': [{'name': 'Mayzent', 'type': 'DRUG', 'description': 'There is no treatment allocation. Patients administered Mayzent by prescription that have started before inclusion of the patient into the study will be enrolled.', 'armGroupLabels': ['Mayzent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '446-8602', 'city': 'Anjo', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.95828, 'lon': 137.08054}}, {'zip': '447-0084', 'city': 'Hekinan', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.88333, 'lon': 136.98333}}, {'zip': '491-0041', 'city': 'Ichinomiya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.3, 'lon': 136.8}}, {'zip': '448-0852', 'city': 'Kariya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.98333, 'lon': 136.98333}}, {'zip': '487-0031', 'city': 'Kasugai', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.24762, 'lon': 136.97229}}, {'zip': '480-1195', 'city': 'Nagakute', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.17325, 'lon': 137.05667}}, {'zip': '451-8511', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '453-0815', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '454-0012', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '455-8530', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '466 8560', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '489-8642', 'city': 'Seto', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.23333, 'lon': 137.1}}, {'zip': '039-1104', 'city': 'Hachinohe', 'state': 'Aomori', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.5, 'lon': 141.5}}, {'zip': '036 8563', 'city': 'Hirosaki', 'state': 'Aomori', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.59306, 'lon': 140.4725}}, {'zip': '299-0111', 'city': 'Ichihara', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.51667, 'lon': 140.08333}}, {'zip': '272-8513', 'city': 'Ichikawa', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.73413, 'lon': 139.9065}}, {'zip': '276-8524', 'city': 'Yachiyo', 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'city': 'Nankoku', 'state': 'Kochi', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.56943, 'lon': 133.64937}}, {'zip': '860-8556', 'city': 'Kumamoto', 'state': 'Kumamoto', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '616-8255', 'city': 'Kyoto', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '513-8505', 'city': 'Suzuka', 'state': 'Mie-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.88333, 'lon': 136.58333}}, {'zip': '514-8507', 'city': 'Tsu', 'state': 'Mie-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.73333, 'lon': 136.51667}}, {'zip': '988-0085', 'city': 'Kesennuma', 'state': 'Miyagi', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.90112, 'lon': 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