Actively Recruiting
Prospective Registry of Patients With Systemic Lupus Erythematosus of the Argentinian Society of Rheumatology
Led by Sociedad Argentina de Reumatologia · Updated on 2022-07-22
1500
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a long-term observational study to gather detailed information on patients with systemic lupus erythematosus (SLE) in Argentina. The study aims to describe the real-world setting of SLE patients, identify barriers to specialized care and treatment access, and collect data from multiple centers over a 5-year follow-up period. This project addresses the current lack of comprehensive data on SLE patients in Latin America. Participants diagnosed with SLE, meeting established criteria, will be followed annually for 5 years. Data collection includes sociodemographic information, clinical history, disease activity and damage scores, treatments used, patient-reported outcomes like quality of life, comorbidities, vaccination status, obstetric history, and hospitalizations. Experienced physicians will enter data into a specially designed electronic form to ensure accuracy and consistency. During the study, patients will have yearly clinical visits to monitor changes in disease status, treatments, healthcare use, and outcomes such as remission, mortality, and drug safety. Researchers will measure remission rates, patient quality of life, disease activity, damage accrual, treatment patterns, drug survival, and adverse events. The study will also assess healthcare resource use and accessibility to high-cost treatments, providing important insights into managing SLE in this population.
CONDITIONS
Brief Title
Argentinian Prospective Registry of Patients With Lupus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older
- Diagnosed with systemic lupus erythematosus (SLE) according to American College of Rheumatology or Systemic Lupus International Collaborating Clinics criteria
- Diagnosis made less than 5 years ago
- Signed informed consent
You will not qualify if you...
- Diagnosis of other systemic autoimmune diseases or overlap syndromes
- Patients who have been transferred to other medical centers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants provide sociodemographic data, clinical history, current clinical manifestations, treatments, and patient-reported outcomes during a baseline visit.
1 baseline visit (in-person)
Duration - Up to 5 years
Participants have yearly clinical follow-up visits to monitor changes in clinical manifestations, treatments, disease activity and damage scores, patient-reported outcomes, hospitalizations, and mortality.
Annual visits for up to 5 years
Trial Site Locations
Total: 1 location
1
Lucila Garcia
La Plata, Buenos Aires, Argentina, 1900
Actively Recruiting
Research Team
G
Guillermo Pons-Estel, PhD
L
Lucila Garcia, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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