Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT05470569
Status:
RECRUITING
Last Update Posted:
2022-07-22
First Post:
2022-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Argentinian Prospective Registry of Patients With Lupus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-20', 'studyFirstSubmitDate': '2022-07-19', 'studyFirstSubmitQcDate': '2022-07-20', 'lastUpdatePostDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'remission', 'timeFrame': '1 year', 'description': 'Number of patients who achieved complete clinical remission or LDAS'}, {'measure': 'patient reported outcomes', 'timeFrame': '1 year', 'description': 'Impact on the quality of life and working life measured by PROs'}, {'measure': 'mortality', 'timeFrame': '1 year', 'description': 'Annual and global mortality during the follow up period'}, {'measure': 'disease activity', 'timeFrame': '1 year', 'description': 'Changes in disease activity (SLEDAI)'}, {'measure': 'accrual damage', 'timeFrame': '1 year', 'description': 'change in accrual damage (SLICC)'}], 'secondaryOutcomes': [{'measure': 'treatment', 'timeFrame': '1 year', 'description': 'Time to high-cost treatment'}, {'measure': 'drug survival', 'timeFrame': '1 year', 'description': 'Survival of main drugs reported as time between the first dose and the last dose'}, {'measure': 'adverse events', 'timeFrame': '1 year', 'description': 'Safety of main drugs assessed as reason for their discontinuation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SLE']}, 'descriptionModule': {'briefSummary': 'In Latin America, information about patients with systemic lupus erythematosus (SLE) is limited. Multicenter studies are needed to obtain "real world data \'\' and to carry out longer follow-ups. The purpose of this project is to design a cohort of Argentinian patients with SLE to describe "our real setting" and to identify possible limitations in access to specialized consultations and treatments.', 'detailedDescription': 'A longitudinal and multicenter cohort study of patients with systemic lupus erythematosus (SLE) is planned, with a follow-up of for 5 years. The data will be obtained from the clinical history of each patient. The responsible for data collection will always be a physician with experience in the management of patients with SLE and who has received training for data loading.\n\nThe data will be collected through the an electronic case report form (eCRF) specially designed for this record and which in turn will facilitate the control of the data and the generation of inquiries to the researchers.\n\nSTUDY VARIABLES\n\nBaseline visit:\n\nSociodemographic data Classification criteria American College of Rheumatology (ACR 1982/1997), Systemic Lupus International Collaborating Clinics (SLICC 2012) and/or European League Against Rheumatism / American College of Rheumatology (EULAR / ACR 2019) History of SLE Access to specialized care Current clinical manifestations Activity and damage Scores Current treatments Patient-Reported Outcomes (PROs): Self-reported quality of life questionnaires EQ-5R; physician global assessment (PGA) and the patient Comorbidities Vaccination Habits Obstetric history Associated antiphospholipid syndrome Hospitalizations for adverse event, infections, or lupus activity\n\nAnnual clinical follow-up visits Clinical follow-up of the patient Changes in clinical manifestations Changes in treatments Use of health services; hospitalizations; high cost treatments Activity and damage scores PROs Annual global and SLE-related mortality\n\nSTUDY ENDPOINTS\n\n* Number of patients who achieved complete clinical remission or low disease activity status (LDAS)\n* Impact on the quality of life and working life measured by PROs and PGA\n* Mortality annual and global during the follow up period\n* Change in disease activity and damage scores\n* Health care resources used reported as number of hospitalizations, emergency visits and need of high cost treatment\n* Accessibility to high cost treatment\n* Survival of mains drugs reported as time between the first dose and the last dose\n* Safety of mains drugs assessed as reason for their discontinuation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with SLE treated and followed up in Rheumatology units belonging to the study group of the Argentine Society of Rheumatology (GESAR-SLE). This is a non-probabilistic sampling study with enrollment of consecutive patients who meet the selection criteria during a one-year enrollment period, added to the patients of RELESSAR I, who meet the inclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 18 years of age\n* Classified as SLE (according to the 1982/1997 American College of Rheumatology criteria and/or Systemic Lupus International Collaborating Clinics criteria for SLE)\n* Less than 5 years from meeting SLE criteria\n* Informed consent signature\n\nExclusion Criteria:\n\n* Diagnosis of other systemic autoimmune diseases or overlap syndromes\n* Patients who have been transferred to other centers'}, 'identificationModule': {'nctId': 'NCT05470569', 'briefTitle': 'Argentinian Prospective Registry of Patients With Lupus', 'organization': {'class': 'OTHER', 'fullName': 'Sociedad Argentina de Reumatologia'}, 'officialTitle': 'Prospective Registry of Patients With Systemic Lupus Erythematosus of the Argentinian Society of Rheumatology', 'orgStudyIdInfo': {'id': 'RELESSAR PROS'}}, 'contactsLocationsModule': {'locations': [{'zip': '1900', 'city': 'La Plata', 'state': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Lucila Garcia', 'role': 'CONTACT', 'email': 'lucilagv96@gmail.com', 'phone': '+54 92216380230'}, {'name': 'Carla Gobbi', 'role': 'CONTACT', 'email': 'carlaandreagobbi@hotmail.com', 'phone': '+54 93572406710'}], 'facility': 'Lucila Garcia', 'geoPoint': {'lat': -34.92126, 'lon': -57.95442}}], 'centralContacts': [{'name': 'Guillermo Pons-Estel, PhD', 'role': 'CONTACT', 'email': 'unisar@reumatologia.org.ar', 'phone': '+543414498750'}, {'name': 'Lucila Garcia, PhD', 'role': 'CONTACT', 'email': 'lucilagarciavar@hotmail.com.ar', 'phone': '+543414498750'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sociedad Argentina de Reumatologia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}