This Project Aims to Understand the Needs of Rheumatologists and Other Specialties in the Care of Patients With SLE

NCT06698900 | Completed

• 1 other identifier: D3461R00089
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Systemic Lupus Erythematosus

Keywords

Lupus; Rheumatologists; Arthritis; Spondylitis

Outcome Measures

Primary Outcomes (1)

• 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

  through study completion, an average of 3 months

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All population data identified in the literature review and desk research; analysis of the National Health Database in Brazil (DataSUS)

You may qualify if:

• \- All the patients with SLE registered in DataSUS, in the outpatient system (SIA) and in the Hospital System (SIH) from 2019 to 2022

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

São Paulo, Brazil

Location

Related Publications (1)

• 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.

  PMID: 41285502 DERIVED

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Arthritis; Spondylitis

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Joint Diseases; Musculoskeletal Diseases; Bone Diseases, Infectious; Infections; Bone Diseases; Spinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: November 21, 2024
• Study Start: November 29, 2024
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

BR (1)