Clinical trial NCT06715254: A Real-world Study of Tuberculosis Incidence in AS, PsA, or PsO Patients Treated With Secukinumab in Brazil
Official title: TuBerculosis Incidence in AS, PsA or Pso Patients Treated With Secukinumab: Real World Evidence in Brazilian Environment (ToBeReal)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Tuberculosis
Keywords: Ankylosing spondylitis
Psoriatic arthritis
Psoriasis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-12-04
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study.

Brief 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.


Eligibility criteria: Inclusion criteria:

1. Documented diagnosis with AS, PsA, or PsO, regardless of its severity, by a physician as per patient chart up to secukinumab introduction.
2. Patient treated with secukinumab monotherapy for at least 24 months since 01 January 2016 in Brazil, in accordance with local labelling approval.
3. Biologic-naïve or secondary-naïve patient, who was not using biologic drug for at least 3 months prior to secukinumab introduction.
4. Medical history available from the entire study period i.e., at least 6 months before and 24 months after secukinumab introduction.

Exclusion criteria:

1. No access or availability of patient medical chart.
2. Patient who did not use approved dosing regimens for secukinumab therapy, as per local label.
3. Patient with confirmed clinical history of active tuberculosis or mendelian susceptibility to mycobacterium diseases prior to secukinumab use.
4. 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.

Primary outcomes:
measure: Number of Active Tuberculosis Cases per 1000 Patient-years in Biologic Naive Patients Treated With Secukinumab
timeFrame: Up to approximately 84 months
Secondary outcomes:
measure: Number of Active Tuberculosis Cases per 1000 Patient-years in all Patients Treated With Secukinumab
timeFrame: Up to approximately 84 months
measure: Number of Active Tuberculosis Cases per 1000 Patient-years in Secondary Naive Patients Treated With Secukinumab
timeFrame: Up to approximately 84 months
measure: Number of Patients per Demographic Category
timeFrame: Baseline
measure: Demographic: Age
timeFrame: Baseline
measure: Demographic: Time to Follow-up From Secukinumab Initiation
timeFrame: Up to approximately 84 months
measure: Number of Patients With Comorbidities up to Secukinumab Initiation
timeFrame: Baseline
measure: Number of Patients per Comorbidity
timeFrame: Baseline
measure: Number of Concomitant Medications Patients Received Before Secukinumab Initiation
timeFrame: Baseline
measure: Number of Concomitant Medications Patients Received After Secukinumab Initiation
timeFrame: Up to approximately 84 months
measure: Mean Number of Medications per Patient Before Secukinumab Initiation
timeFrame: Baseline
measure: Mean Number of Medications per Patient After Secukinumab Initiation
timeFrame: Up to approximately 84 months
measure: Number of Concomitant Medications Prescribed Before Secukinumab Initiation Categorized by Reason for Medication Prescription
timeFrame: Baseline
measure: Number of Concomitant Medications Prescribed After Secukinumab Initiation Categorized by Reason for Medication Prescription
timeFrame: Up to approximately 84 months
measure: Number of Most Frequent Medications Used for Comorbidities Before Secukinumab Initiation Categorized by Type of Medication
timeFrame: Baseline
measure: Number of Most Frequent Medications Used for Comorbidities After Secukinumab Initiation Categorized by Type of Medication
timeFrame: Up to approximately 84 months
measure: Number of Medications Prescribed for AS, PsA, or PSO Before Secukinumab Initiation Categorized by Type of Medication
timeFrame: Baseline
measure: Number of Medications Prescribed for AS, PsA, or PSO After Secukinumab Initiation Categorized by Type of Medication
timeFrame: Up to approximately 84 months
measure: Duration of Primary Diagnosis
timeFrame: Baseline
measure: Duration of Secukinumab Treatment
timeFrame: Up to approximately 84 months
measure: Number of Patients per Secukinumab Use Category
timeFrame: Up to approximately 84 months
measure: Duration of Interruption of Secukinumab Treatment
timeFrame: Up to approximately 84 months
measure: Number of Patients who Used an Immunobiologic Before Secukinumab
timeFrame: Baseline
measure: Number of Patients who Tested Positive or Negative for Latent Tuberculosis Before Secukinumab Initiation
timeFrame: Approximately 6 months
measure: Number of Patients who Received Prophylactic Antibiotic Therapy Among Those who Tested Positive for Latent Tuberculosis Before Secukinumab Initiation
timeFrame: Approximately 6 months
measure: Number of Patients who Tested Positive or Negative for Latent Tuberculosis After Secukinumab Initiation
timeFrame: Up to approximately 84 months
measure: Number of Patients who Received Prophylactic Antibiotic Therapy Among Those who Tested Positive for Latent Tuberculosis After Secukinumab Initiation
timeFrame: Up to approximately 84 months
measure: Number of Patients not Tested for Tuberculosis Before Secukinumab Initiation With Prophylactic Antibiotic Use
timeFrame: Approximately 6 months
measure: Number of Patients Without a Tuberculosis Test Before Secukinumab Initiation
timeFrame: Approximately 6 months
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: