Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT03994302
Status:
COMPLETED
Last Update Posted:
2023-04-13
First Post:
2019-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Monitoring the Antiphospholipid Syndrome:TOXicity of Drugs (APSTOX)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016736', 'term': 'Antiphospholipid Syndrome'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}], 'ancestors': [{'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2700}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-04-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-12', 'studyFirstSubmitDate': '2019-06-19', 'studyFirstSubmitQcDate': '2019-06-19', 'lastUpdatePostDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immune toxicities (such as Antiphospholipid Syndrome) of drugs Identification and report of immune toxicities associated with drugs.', 'timeFrame': '01/06/2019', 'description': 'Case reported in the World Health Organization (WHO) database of individual safety case reports'}], 'secondaryOutcomes': [{'measure': 'Causality assessment of reported metabolic toxicities events according to the WHO system Case reported in the World Health Organization (WHO) database of individual safety case reports', 'timeFrame': '01/06/2019'}, {'measure': 'Description of the type of immune toxicity depending on the category of drug Case reported in the World Health Organization (WHO) database of individual safety case reports', 'timeFrame': '01/06/2019'}, {'measure': 'Description of the other immune related adverse events concomitant to the immune toxicity induced by drugs Case reported in the World Health Organization (WHO) database of individual safety case reports', 'timeFrame': '01/06/2019'}, {'measure': 'Description of the duration of treatment when the toxicity happens (role of cumulative dose) Case reported in the World Health Organization (WHO) database of individual safety case reports', 'timeFrame': '01/06/2019'}, {'measure': 'Description of the drug-drug interactions associated with adverse events Case reported in the World Health Organization (WHO) database of individual safety case reports', 'timeFrame': '01/06/2019'}, {'measure': 'Description of the pathologies (cancer) for which the incriminated drugs have been prescribed Case reported in the World Health Organization (WHO) database of individual safety case reports', 'timeFrame': '01/06/2019'}, {'measure': 'Description of the population of patients having hematological toxicity adverse event Case reported in the World Health Organization (WHO) database of individual safety case reports', 'timeFrame': '01/06/2019'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Antiphospholipid Syndrome', 'Immune Disease', 'Adverse Drug Event', 'Drug Toxicity']}, 'referencesModule': {'references': [{'pmid': '35114404', 'type': 'DERIVED', 'citation': 'Gerardin C, Bihan K, Salem JE, Khachatryan H, Gerotziafas G, Fain O, Mekinian A. Drug-induced antiphospholipid syndrome: Analysis of the WHO international database. Autoimmun Rev. 2022 May;21(5):103060. doi: 10.1016/j.autrev.2022.103060. Epub 2022 Feb 1.'}]}, 'descriptionModule': {'briefSummary': 'Several drugs and chemotherapies seem to have an impact on the immune system. This study investigates reports of immune toxicities such as antiphospholipid syndrome, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).', 'detailedDescription': 'Several drugs and chemotherapies seem to have an impact on the immune system and are responsible of a wide range of immune side effects such as antiphospholipid syndrome. Those are poorly described, due to the modificationof the pharmacopeia, and the recent recognition of several of these adverseevents.\n\nThis study investigates the main characteristics of patients affected by immune side effects imputed to drugs in particular antiphospholipid syndrome.\n\nA causality assessment according to the WHO-UMC (World Health Organization - Uppsala Monitoring Center) is systematically applied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients treated with a drug that could be reported in the WHO's pharmacovigilance database", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- Case reported in the WHO's pharmacovigilance database till 01/06/2019\n\nExclusion Criteria:\n\n* Chronology not compatible between the drug and the toxicity"}, 'identificationModule': {'nctId': 'NCT03994302', 'acronym': 'APSTOX', 'briefTitle': 'Monitoring the Antiphospholipid Syndrome:TOXicity of Drugs (APSTOX)', 'organization': {'class': 'OTHER', 'fullName': 'Groupe Hospitalier Pitie-Salpetriere'}, 'officialTitle': 'Monitoring the Antiphospholipid Syndrome:TOXicity of Drugs (APSTOX)', 'orgStudyIdInfo': {'id': 'CIC1421-19-10'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Immune toxicity induced by drugs and chemotherapies', 'description': 'Immune toxicity induced by drugs and chemotherapies Case reported in the World Health Organization (WHO) of immune toxicities(such as Antiphospholipid syndrome) of patient treated by a drug, with a chronology compatible with the drug toxicity', 'interventionNames': ['Drug: Drug inducing antiphospholipid syndrome']}], 'interventions': [{'name': 'Drug inducing antiphospholipid syndrome', 'type': 'DRUG', 'description': 'Drugs susceptible to induce immune toxicities such as antiphospholipid syndrome', 'armGroupLabels': ['Immune toxicity induced by drugs and chemotherapies']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Groupe Hospitalier Pitie-Salpetriere', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant director, clinical investigation center Paris Est', 'investigatorFullName': 'Joe Elie Salem', 'investigatorAffiliation': 'Groupe Hospitalier Pitie-Salpetriere'}}}}