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NCT06715254 · ClinicalTrials.gov registry record
A Real-world Study of Tuberculosis Incidence in AS, PsA, or PsO Patients Treated With Secukinumab in Brazil
A clinical trial, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- 152
- Enrollment target
NCT06715254: Clinical Trial study, sponsored by Novartis Pharmaceuticals.
NCT06715254 is a clinical trial that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 152 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06715254 was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- 152 participants
- Enrollment target
Study 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.
Primary Outcome
Biologic naive patients were defined as patients with no previous therapeutic exposure to biologic drugs. Biologic drugs considered were abatacept, adalimumab, certolizumab, etanercept, golimumab, guselkumab, infliximab, ixequizumab, tofacitinibe, and ustekinumab.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2021-07-23 |
| Est. Completion | 2023-11-30 |
Why NCT06715254 stopped before completion
NCT06715254 is an observational study that tracks outcomes without assigning an intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT06715254 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06715254 about?
NCT06715254 is a clinical study titled "A Real-world Study of Tuberculosis Incidence in AS, PsA, or PsO Patients Treated With Secukinumab in Brazil". 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 f...
What is the current status of trial NCT06715254?
This trial is currently terminated. The enrollment target is 152 participants. The study started on 2021-07-23. Estimated completion is 2023-11-30.
Who is sponsoring clinical trial NCT06715254?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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