Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT05470569
Status:
RECRUITING
Last Update Posted:
2022-07-22
First Post:
2022-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Argentinian Prospective Registry of Patients With Lupus
Sponsor:
Sociedad Argentina de Reumatologia
Organization:
Study Overview
Official Title:
Prospective Registry of Patients With Systemic Lupus Erythematosus of the Argentinian Society of Rheumatology
Status:
RECRUITING
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: