NCT05470569

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Apr 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Apr 2022Apr 2027

Study Start

First participant enrolled

April 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 22, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Expected
Last Updated

July 22, 2022

Status Verified

June 1, 2022

Enrollment Period

1 year

First QC Date

July 19, 2022

Last Update Submit

July 20, 2022

Conditions

SLE

Outcome Measures

Primary Outcomes (5)

  • remission

    Number of patients who achieved complete clinical remission or LDAS

    1 year

  • patient reported outcomes

    Impact on the quality of life and working life measured by PROs

    1 year

  • mortality

    Annual and global mortality during the follow up period

    1 year

  • disease activity

    Changes in disease activity (SLEDAI)

    1 year

  • accrual damage

    change in accrual damage (SLICC)

    1 year

Secondary Outcomes (3)

  • treatment

    1 year

  • drug survival

    1 year

  • adverse events

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Diagnosis of other systemic autoimmune diseases or overlap syndromes
  • Patients who have been transferred to other centers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lucila Garcia

La Plata, Buenos Aires, 1900, Argentina

RECRUITING

Central Study Contacts

Guillermo Pons-Estel, PhD

CONTACT

+543414498750unisar@reumatologia.org.ar

Lucila Garcia, PhD

CONTACT

+543414498750lucilagarciavar@hotmail.com.ar

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2022

First Posted

July 22, 2022

Study Start

April 1, 2022

Primary Completion

April 1, 2023

Study Completion (Estimated)

April 1, 2027

Last Updated

July 22, 2022

Record last verified: 2022-06

Locations

AR(1)