Actively Recruiting

Age: 18Years +
All Genders
ID05470569

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Baseline Data Collection

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)

Annual Clinical Follow-up

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

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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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