A Real-world Study of Tuberculosis Incidence in AS, PsA, or PsO Patients Treated With Secukinumab… (NCT06715254) | Clinical Trial Compass
TerminatedNot Applicable
A Real-world Study of Tuberculosis Incidence in AS, PsA, or PsO Patients Treated With Secukinumab in Brazil
Stopped: Due to the limited availability of eligible patients who met the study's criteria, as well as there has not been a case of tuberculosis, the study was terminated early.
United States152 participantsStarted 2021-07-23
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Documented diagnosis with AS, PsA, or PsO, regardless of its severity, by a physician as per patient chart up to secukinumab introduction.
. Patient treated with secukinumab monotherapy for at least 24 months since 01 January 2016 in Brazil, in accordance with local labelling approval.
. Biologic-naïve or secondary-naïve patient, who was not using biologic drug for at least 3 months prior to secukinumab introduction.
. Medical history available from the entire study period i.e., at least 6 months before and 24 months after secukinumab introduction.
Exclusion criteria
. No access or availability of patient medical chart.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Active Tuberculosis Cases per 1000 Patient-years in Biologic Naive Patients Treated With Secukinumab
. Patient who did not use approved dosing regimens for secukinumab therapy, as per local label.
. Patient with confirmed clinical history of active tuberculosis or mendelian susceptibility to mycobacterium diseases prior to secukinumab use.
. Patient treated with systemic corticosteroid doses with immunosuppressant features (prednisone dose higher than 10 milligrams \[mg\] or its equivalent) for at least 2 consecutive weeks or other concomitant immunosuppressant drug during the study period.