Clinical trial NCT05470569: Argentinian Prospective Registry of Patients With Lupus
Official title: Prospective Registry of Patients With Systemic Lupus Erythematosus of the Argentinian Society of Rheumatology
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: SLE
Lead sponsor: Sociedad Argentina de Reumatologia
Sponsor class: OTHER
First posted: 2022-07-22
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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

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

Primary outcomes:
measure: remission
timeFrame: 1 year
measure: patient reported outcomes
timeFrame: 1 year
measure: mortality
timeFrame: 1 year
measure: disease activity
timeFrame: 1 year
measure: accrual damage
timeFrame: 1 year
Secondary outcomes:
measure: treatment
timeFrame: 1 year
measure: drug survival
timeFrame: 1 year
measure: adverse events
timeFrame: 1 year
Other outcomes:
Locations:
city: La Plata
country: Argentina
facility: Lucila Garcia
state: Buenos Aires
Study officials:
References: