Argentinian Prospective Registry of Patients With Lupus
NCT ID: NCT05470569
Last Updated: 2022-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1500 participants
OBSERVATIONAL
2022-04-01
2027-04-01
Brief Summary
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Detailed Description
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The 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.
STUDY VARIABLES
Baseline visit:
Sociodemographic 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
Annual 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
STUDY ENDPOINTS
* Number of patients who achieved complete clinical remission or low disease activity status (LDAS)
* Impact on the quality of life and working life measured by PROs and PGA
* Mortality annual and global during the follow up period
* Change in disease activity and damage scores
* Health care resources used reported as number of hospitalizations, emergency visits and need of high cost treatment
* Accessibility to high cost treatment
* Survival of mains drugs reported as time between the first dose and the last dose
* Safety of mains drugs assessed as reason for their discontinuation
Conditions
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Classified as SLE (according to the 1982/1997 American College of Rheumatology criteria and/or Systemic Lupus International Collaborating Clinics criteria for SLE)
* Less than 5 years from meeting SLE criteria
* Informed consent signature
Exclusion Criteria
* Patients who have been transferred to other centers
18 Years
ALL
No
Sponsors
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Sociedad Argentina de Reumatologia
OTHER
Responsible Party
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Locations
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Lucila Garcia
La Plata, Buenos Aires, Argentina
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RELESSAR PROS
Identifier Type: -
Identifier Source: org_study_id
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