Systemic Lupus ErythematosusLESBRANCT06698900
This Project Aims to Understand the Needs of Rheumatologists and Other Specialties in the Care of Patients With SLE
An observational study of Systemic Lupus Erythematosus, run by AstraZeneca at 1 site in Brazil.
Trial summary
The project will be conducted in four distinct stages. Firstly, evidence synthesis will be carried out to gather and analyze available data on the topic. Following this, a discussion among physicians will be facilitated to understand the knowledge gaps among rheumatologists and other specialists regarding SLE. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- How many people
- 1,000 participants
- Where
- 1 siteBrazil
- Study dates
- 29 Nov 2024to 20 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All population data identified in the literature review and desk research; analysis of the National Health Database in Brazil (DataSUS)
Who may be able to join
- All the patients with SLE registered in DataSUS, in the outpatient system (SIA) and in the Hospital System (SIH) from 2019 to 2022
Who cannot join
- Not applicable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Generating Evidence Study for Systemic Lupus Erythematosus Using Different Types of Methodologies
The project will be conducted in four distinct stages. Firstly, evidence synthesis will be carried out to gather and analyze available data on the topic. Following this, a discussion among physicians will be facilitated to understand the knowledge gaps among rheumatologists and other specialists regarding SLE. Subsequently, consensus will be sought among a select group of rheumatologists on various aspects related to patient care, unmet medical needs, and implementation of new technologies. Finally, the findings and conclusions from these stages will be used to inform the development and publication of scientific papers.
Read the detailed description
This study has as geral objective understanding the currently unmet development needs of rheumatologists and other specialists involved in the care of patients with SLE, from a comparative perspective with other rheumatic diseases. The goal is to increase the engagement of these professionals in the discussion and management of patients and sécific objectives, compare the currently available evidence on SLE and three other rheumatic diseases (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis); Promote discussions to understand the knowledge development needs of rheumatologists regarding SLE; Generate a consensus on the equity of rheumatic diseases in relation to public policies, guidelines, registries, patient association mobilization, patient journey, time to diagnosis, and available medications with access to treatment and, Promote awareness and knowledge through scientific publications about SLE.
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Lupus, Rheumatologists, Arthritis, Spondylitis
- Medical subject headings
- Lupus Erythematosus, Systemic, Arthritis, Spondylitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Understand the difficulties faced by patients with SLE and identify gaps in diagnosis and treatment
Prepare an evidence synthesis using available data, discuss the topic with medical experts to understand knowledge gaps among rheumatologists and other professionals regarding SLE, and build consensus among a group on various aspects related to patient care, unmet medical needs, and implementation of new technologies
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start29 Nov 2024
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698900
- Sponsor's protocol ID
- D3461R00089
- Acronym
- LESBRA
- Status last verified
- Dec 2025
- First submitted
- 21 Oct 2024
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Publications
Monticielo OA, Seguro LPC, de Ataide Mariz H, Daher Macedo M, Therumi Assao V, Lima J, Volpi E Silva N, Dos Reis-Neto ET. Current landscape of immune-mediated inflammatory rheumatic diseases in Brazil's public and private systems: retrospective cohort study. BMJ Open. 2025 Nov 23;15(11):e104870. doi: 10.1136/bmjopen-2025-104870.
PubMed 41285502
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generating Evidence Study for Systemic Lupus Erythematosus Using Different Types of Methodologies
- ClinicalTrials.gov ID
- NCT06698900
- Acronym / sponsor ID
- LESBRA / D3461R00089
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Lupus, Rheumatologists, Arthritis, Spondylitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 21 Nov 2024 (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.
The project will be conducted in four distinct stages. Firstly, evidence synthesis will be carried out to gather and analyze available data on the topic. Following this, a discussion among physicians will be facilitated to understand the knowledge gaps among rheumatologists and other specialists regarding SLE. Subsequently, consensus will be sought among a select group of rheumatologists on various aspects related to patient care, unmet medical needs, and implementation of new technologies. Finally, the findings and conclusions from these stages will be used to inform the development and publication of scientific papers.
Detailed description
This study has as geral objective understanding the currently unmet development needs of rheumatologists and other specialists involved in the care of patients with SLE, from a comparative perspective with other rheumatic diseases. The goal is to increase the engagement of these professionals in the discussion and management of patients and sécific objectives, compare the currently available evidence on SLE and three other rheumatic diseases (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis); Promote discussions to understand the knowledge development needs of rheumatologists regarding SLE; Generate a consensus on the equity of rheumatic diseases in relation to public policies, guidelines, registries, patient association mobilization, patient journey, time to diagnosis, and available medications with access to treatment and, Promote awareness and knowledge through scientific publications about SLE.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All population data identified in the literature review and desk research; analysis of the National Health Database in Brazil (DataSUS)
Key inclusion criteria (1 listed)
- All the patients with SLE registered in DataSUS, in the outpatient system (SIA) and in the Hospital System (SIH) from 2019 to 2022
Key exclusion criteria (1 listed)
- Not applicable
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
Understand the difficulties faced by patients with SLE and identify gaps in diagnosis and treatment
Time frame: through study completion, an average of 3 months
Prepare an evidence synthesis using available data, discuss the topic with medical experts to understand knowledge gaps among rheumatologists and other professionals regarding SLE, and build consensus among a group on various aspects related to patient care, unmet medical needs, and implementation of new technologies
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Derived from this study: PubMed 41285502Monticielo OA, Seguro LPC, de Ataide Mariz H, Daher Macedo M, Therumi Assao V, Lima J, Volpi E Silva N, Dos Reis-Neto ET. Current landscape of immune-mediated inflammatory rheumatic diseases in Brazil's public and private systems: retrospective cohort study. BMJ Open. 2025 Nov 23;15(11):e104870. doi: 10.1136/bmjopen-2025-104870.
- CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Related trials for Systemic Lupus Erythematosus
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Systemic Lupus Erythematosus, run by AstraZeneca at 1 site in Brazil.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 16 Dec 2025. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Understand the difficulties faced by patients with SLE and identify gaps in diagnosis and treatment (time frame: through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06698900, which also lists 1 linked publication.
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 16 Dec 2025.