Argentinian Prospective Registry of Patients With Lupus
ConditionSLE
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSociedad Argentina de Reumatologia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Diagnosis of other systemic autoimmune diseases or overlap syndromes
Patients who have been transferred to other centers
Trial 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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
remission
Number of patients who achieved complete clinical remission or LDAS
Time frame
1 year2
patient reported outcomes
Impact on the quality of life and working life measured by PROs
Time frame
1 year3
mortality
Annual and global mortality during the follow up period
Time frame
1 year4
disease activity
Changes in disease activity (SLEDAI)
Time frame
1 yearSecondary outcomes
1
treatment
Time to high-cost treatment
Time frame
1 year2
drug survival
Survival of main drugs reported as time between the first dose and the last dose
Time frame
1 year3
adverse events
Safety of main drugs assessed as reason for their discontinuation
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov