NCT06715254

A Real-world Study of Tuberculosis Incidence in AS, PsA, or PsO Patients Treated With Secukinumab in Brazil

TuBerculosis Incidence in AS, PsA or Pso Patients Treated With Secukinumab: Real World Evidence in Brazilian Environment (ToBeReal)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 152 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was a retrospective observational study that relied on data extracted from patient's chart review at the participating centers. Data was entered into an electronic Case Report Form (eCRF) designed to capture all relevant information to achieve the study objectives. After the ethical approval for each participating site, the respective Investigator and/or designated qualified study staff were responsible for including all eligible patients in a consecutive manner and entering their information into the eCRF. Patients were primarily identified with ankylosing spondylitis (AS), psoriatic arthritis (PsA), and psoriasis (PsO) diagnosis according to the International Classification of Diseases (ICD)-10 code (M45, M07, and L40, respectively). Alternatively, the written diagnosis from applicable departments, such as payment, computing, or data office were also used for patient screening. Potentially eligible patients had their charts reviewed for all selection criteria. Inclusion was performed up to the number of patients determined for each site prior to study initiation or up to completion of sample size. Patient's identification (name, address, and other identifiable data) was not collected and remained confidential.

Conditions

• Tuberculosis

Timeline

• Start date: 2021-07-23
• Primary completion: 2023-11-30
• Completion: 2023-11-30
• First posted: 2024-12-04
• Last updated: 2024-12-04

Locations

1 site across 1 country: United States