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Argentinian Prospective Registry of Patients With Lupus

Sponsor
Sociedad Argentina de Reumatologia (Other)
Overall Status
Recruiting
CT.gov ID
NCT05470569
Collaborator
(none)
1,500
Enrollment
1
Location
60
Anticipated Duration (Months)
25
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1500 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Prospective Registry of Patients With Systemic Lupus Erythematosus of the Argentinian Society of Rheumatology
    Actual Study Start Date :
    Apr 1, 2022
    Anticipated Primary Completion Date :
    Apr 1, 2023
    Anticipated Study Completion Date :
    Apr 1, 2027

    Outcome Measures

    Primary Outcome Measures

    1. remission [1 year]

      Number of patients who achieved complete clinical remission or LDAS

    2. patient reported outcomes [1 year]

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

    3. mortality [1 year]

      Annual and global mortality during the follow up period

    4. disease activity [1 year]

      Changes in disease activity (SLEDAI)

    5. accrual damage [1 year]

      change in accrual damage (SLICC)

    Secondary Outcome Measures

    1. treatment [1 year]

      Time to high-cost treatment

    2. drug survival [1 year]

      Survival of main drugs reported as time between the first dose and the last dose

    3. adverse events [1 year]

      Safety of main drugs assessed as reason for their discontinuation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lucila Garcia La Plata Buenos Aires Argentina 1900

    Sponsors and Collaborators

    • Sociedad Argentina de Reumatologia

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sociedad Argentina de Reumatologia
    ClinicalTrials.gov Identifier:
    NCT05470569
    Other Study ID Numbers:
    • RELESSAR PROS
    First Posted:
    Jul 22, 2022
    Last Update Posted:
    Jul 22, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jul 22, 2022