SLENCT05470569
Argentinian Prospective Registry of Patients With Lupus
An observational study of SLE, run by Sociedad Argentina de Reumatologia at 1 site in Argentina.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SLE
- How many people
- 1,500 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Apr 2022to 1 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Diagnosis of other systemic autoimmune diseases or overlap syndromes
- Patients who have been transferred to other centers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Argentina1 site, 1 recruiting
- Recruiting
Lucila Garcia
La Plata, Buenos Aires, 1900
Lucila Garcia, +54 92216380230, lucilagv96@gmail.com
Carla Gobbi, +54 93572406710, carlaandreagobbi@hotmail.com
About this study
Official title: Prospective Registry of Patients With Systemic Lupus Erythematosus of the Argentinian Society of Rheumatology
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.
Read the 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
- Conditions
- SLE
What is being measured
The primary outcome is the main question the study is designed to answer.
remission
Number of patients who achieved complete clinical remission or LDAS
Measured: 1 year
patient reported outcomes
Impact on the quality of life and working life measured by PROs
Measured: 1 year
mortality
Annual and global mortality during the follow up period
Measured: 1 year
disease activity
Changes in disease activity (SLEDAI)
Measured: 1 year
accrual damage
change in accrual damage (SLICC)
Measured: 1 year
Secondary outcomes (3)
treatment
Time to high-cost treatment
Measured: 1 year
drug survival
Survival of main drugs reported as time between the first dose and the last dose
Measured: 1 year
adverse events
Safety of main drugs assessed as reason for their discontinuation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start1 Apr 2022
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SLEStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sociedad Argentina de Reumatologia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05470569
- Sponsor's protocol ID
- RELESSAR PROS
- Status last verified
- Jun 2022
- First submitted
- 19 Jul 2022
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry of Patients With Systemic Lupus Erythematosus of the Argentinian Society of Rheumatology
- ClinicalTrials.gov ID
- NCT05470569
- Acronym / sponsor ID
- RELESSAR PROS
- Conditions
- SLE
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Sociedad Argentina de ReumatologiaUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 22 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Diagnosis of other systemic autoimmune diseases or overlap syndromes
- Patients who have been transferred to other centers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
remission
Time frame: 1 year
Number of patients who achieved complete clinical remission or LDAS
patient reported outcomes
Time frame: 1 year
Impact on the quality of life and working life measured by PROs
mortality
Time frame: 1 year
Annual and global mortality during the follow up period
disease activity
Time frame: 1 year
Changes in disease activity (SLEDAI)
accrual damage
Time frame: 1 year
change in accrual damage (SLICC)
3 secondary outcomes
treatment
Time frame: 1 year
drug survival
Time frame: 1 year
adverse events
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SLE, run by Sociedad Argentina de Reumatologia at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillermo Pons-Estel, PhD (+543414498750, unisar@reumatologia.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
remission (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.