Argentinian Prospective Registry of Patients With Lupus

SLE Clinical Trial

Official title:

Prospective Registry of Patients With Systemic Lupus Erythematosus of the Argentinian Society of Rheumatology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05470569
• Other study ID #: RELESSAR PROS
• Status: Recruiting
• Start date: April 1, 2022
• Est. completion date: April 1, 2027

Study information

• Verified date: June 2022
• Source: Sociedad Argentina de Reumatologia
• Contact: Guillermo Pons-Estel, PhD
• Phone: +543414498750
• Email: unisar[@]reumatologia.org.ar
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: April 1, 2027
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• SLE

Locations

Country	Name	City	State
Argentina	Lucila Garcia	La Plata	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Sociedad Argentina de Reumatologia

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	remission	Number of patients who achieved complete clinical remission or LDAS	1 year
Primary	patient reported outcomes	Impact on the quality of life and working life measured by PROs	1 year
Primary	mortality	Annual and global mortality during the follow up period	1 year
Primary	disease activity	Changes in disease activity (SLEDAI)	1 year
Primary	accrual damage	change in accrual damage (SLICC)	1 year
Secondary	treatment	Time to high-cost treatment	1 year
Secondary	drug survival	Survival of main drugs reported as time between the first dose and the last dose	1 year
Secondary	adverse events	Safety of main drugs assessed as reason for their discontinuation	1 year