Argentinian Prospective Registry of Patients With Lupus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: SLE. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Argentina
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Registry of Patients With Systemic Lupus Erythematosus of the Argentinian Society of Rheumatology
Overview
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.
Detailed description
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.
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
Primary outcome measures
- remission [Time frame: 1 year]
- patient reported outcomes [Time frame: 1 year]
- mortality [Time frame: 1 year]
- disease activity [Time frame: 1 year]
- accrual damage [Time frame: 1 year]
Secondary outcome measures (3)
- treatment [Time frame: 1 year]
- drug survival [Time frame: 1 year]
- adverse events [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- Patients ≥ 18 years of age
- 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
- Diagnosis of other systemic autoimmune diseases or overlap syndromes
- Patients who have been transferred to other centers
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Argentina · 1 center
- Lucila Garcia — La Plata
Identifiers
NCT: NCT05470569 · RELESSAR PROS