TuberculosisToBeRealNCT06715254
A Real-world Study of Tuberculosis Incidence in AS, PsA, or PsO Patients Treated With Secukinumab in Brazil
An observational study of Tuberculosis, run by Novartis Pharmaceuticals at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2021to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This was a retrospective, noninterventional cohort study.
Who may be able to join
- 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.
Who cannot join
- No access or availability of patient medical chart.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TuBerculosis Incidence in AS, PsA or Pso Patients Treated With Secukinumab: Real World Evidence in Brazilian Environment (ToBeReal)
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
- Keywords
- Ankylosing spondylitis, Psoriatic arthritis, Psoriasis
- Medical subject headings
- Tuberculosis, Spondylitis, Ankylosing, Arthritis, Psoriatic, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ankylosing Spondylitis (AS) Cohort | Adult patients diagnosed with AS who were treated with secukinumab. | |
| Psoriatic Arthritis (PsA) Cohort | Adult patients diagnosed with PsA who were treated with secukinumab. | |
| Psoriasis (PsO) Cohort | Adult patients diagnosed with PsO who were treated with secukinumab. | |
| Overall Cohort | Adult patients diagnosed with AS, PsA, or PsO who were treated with secukinumab. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Active Tuberculosis Cases per 1000 Patient-years in Biologic Naive Patients Treated With Secukinumab
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.
Measured: Up to approximately 84 months
Secondary outcomes (28)
Number of Active Tuberculosis Cases per 1000 Patient-years in all Patients Treated With Secukinumab
Measured: Up to approximately 84 months
Number of Active Tuberculosis Cases per 1000 Patient-years in Secondary Naive Patients Treated With Secukinumab
Secondary-naïve patients were defined as patients with previous exposure to a biologic drug but with a wash-out period of at least 3 months prior to the index date. The index date was defined as the date when secukinumab was introduced. Biologic drugs considered were abatacept, adalimumab, certolizumab, etanercept, golimumab, guselkumab, infliximab, ixequizumab, tofacitinibe, and ustekinumab.
Measured: Up to approximately 84 months
Number of Patients per Demographic Category
Demographic categories included gender and ethnicity.
Measured: Baseline
Demographic: Age
Measured: Baseline
Demographic: Time to Follow-up From Secukinumab Initiation
Measured: Up to approximately 84 months
Number of Patients With Comorbidities up to Secukinumab Initiation
Measured: Baseline
Number of Patients per Comorbidity
Measured: Baseline
Number of Concomitant Medications Patients Received Before Secukinumab Initiation
Measured: Baseline
Number of Concomitant Medications Patients Received After Secukinumab Initiation
Measured: Up to approximately 84 months
Mean Number of Medications per Patient Before Secukinumab Initiation
Measured: Baseline
Mean Number of Medications per Patient After Secukinumab Initiation
Measured: Up to approximately 84 months
Number of Concomitant Medications Prescribed Before Secukinumab Initiation Categorized by Reason for Medication Prescription
Measured: Baseline
Number of Concomitant Medications Prescribed After Secukinumab Initiation Categorized by Reason for Medication Prescription
Measured: Up to approximately 84 months
Number of Most Frequent Medications Used for Comorbidities Before Secukinumab Initiation Categorized by Type of Medication
Measured: Baseline
Number of Most Frequent Medications Used for Comorbidities After Secukinumab Initiation Categorized by Type of Medication
Measured: Up to approximately 84 months
Number of Medications Prescribed for AS, PsA, or PSO Before Secukinumab Initiation Categorized by Type of Medication
Measured: Baseline
Number of Medications Prescribed for AS, PsA, or PSO After Secukinumab Initiation Categorized by Type of Medication
Measured: Up to approximately 84 months
Duration of Primary Diagnosis
Measured: Baseline
Duration of Secukinumab Treatment
Measured: Up to approximately 84 months
Number of Patients per Secukinumab Use Category
Secukinumab use categories included:
- Loading dose prescribed (yes/no)
- Loading dose (150 milligrams [mg] or 300 mg)
- Loading dose frequency (once a day, twice a day, every 1, 2, 3, 4 weeks)
- Period of loading dosage (1, 2, 3 weeks, 1, 2 months, other)
- Maintenance dose (150 mg or 300 mg)
- Maintenance dose frequency (once a day, twice a day, every 1, 2, 3, 4 weeks)
- Switch in dose
- Switch dose (150 mg or 300 mg)
- Frequency of switch dose (once a day, twice a day, every 1, 2, 3, 4 weeks)
- Interruption of secukinumab treatment
Measured: Up to approximately 84 months
Duration of Interruption of Secukinumab Treatment
Interruption duration: interruption date of secukinumab minus restart date of secukinumab.
Measured: Up to approximately 84 months
Number of Patients who Used an Immunobiologic Before Secukinumab
Measured: Baseline
Number of Patients who Tested Positive or Negative for Latent Tuberculosis Before Secukinumab Initiation
Measured: Approximately 6 months
Number of Patients who Received Prophylactic Antibiotic Therapy Among Those who Tested Positive for Latent Tuberculosis Before Secukinumab Initiation
Measured: Approximately 6 months
Number of Patients who Tested Positive or Negative for Latent Tuberculosis After Secukinumab Initiation
Measured: Up to approximately 84 months
Number of Patients who Received Prophylactic Antibiotic Therapy Among Those who Tested Positive for Latent Tuberculosis After Secukinumab Initiation
Measured: Up to approximately 84 months
Number of Patients not Tested for Tuberculosis Before Secukinumab Initiation With Prophylactic Antibiotic Use
Measured: Approximately 6 months
Number of Patients Without a Tuberculosis Test Before Secukinumab Initiation
Measured: Approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start23 Jul 2021
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715254
- Sponsor's protocol ID
- CAIN457FBR03
- Acronym
- ToBeReal
- Status last verified
- Nov 2024
- First submitted
- 28 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TuBerculosis Incidence in AS, PsA or Pso Patients Treated With Secukinumab: Real World Evidence in Brazilian Environment (ToBeReal)
- ClinicalTrials.gov ID
- NCT06715254
- Acronym / sponsor ID
- ToBeReal / CAIN457FBR03
- Conditions
- Tuberculosis
- Keywords
- Ankylosing spondylitis, Psoriatic arthritis, Psoriasis
- Study type
- Observational
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 23 Jul 2021 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ankylosing Spondylitis (AS) Cohort | – | –Adult patients diagnosed with AS who were treated with secukinumab. |
| Psoriatic Arthritis (PsA) Cohort | – | –Adult patients diagnosed with PsA who were treated with secukinumab. |
| Psoriasis (PsO) Cohort | – | –Adult patients diagnosed with PsO who were treated with secukinumab. |
| Overall Cohort | – | –Adult patients diagnosed with AS, PsA, or PsO who were treated with secukinumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was a retrospective, noninterventional cohort study.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- No access or availability of patient medical chart.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Active Tuberculosis Cases per 1000 Patient-years in Biologic Naive Patients Treated With Secukinumab
Time frame: Up to approximately 84 months
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.
28 secondary outcomes
Number of Active Tuberculosis Cases per 1000 Patient-years in all Patients Treated With Secukinumab
Time frame: Up to approximately 84 months
Number of Active Tuberculosis Cases per 1000 Patient-years in Secondary Naive Patients Treated With Secukinumab
Time frame: Up to approximately 84 months
Number of Patients per Demographic Category
Time frame: Baseline
Demographic: Age
Time frame: Baseline
Demographic: Time to Follow-up From Secukinumab Initiation
Time frame: Up to approximately 84 months
Number of Patients With Comorbidities up to Secukinumab Initiation
Time frame: Baseline
Number of Patients per Comorbidity
Time frame: Baseline
Number of Concomitant Medications Patients Received Before Secukinumab Initiation
Time frame: Baseline
Number of Concomitant Medications Patients Received After Secukinumab Initiation
Time frame: Up to approximately 84 months
Mean Number of Medications per Patient Before Secukinumab Initiation
Time frame: Baseline
Mean Number of Medications per Patient After Secukinumab Initiation
Time frame: Up to approximately 84 months
Number of Concomitant Medications Prescribed Before Secukinumab Initiation Categorized by Reason for Medication Prescription
Time frame: Baseline
Number of Concomitant Medications Prescribed After Secukinumab Initiation Categorized by Reason for Medication Prescription
Time frame: Up to approximately 84 months
Number of Most Frequent Medications Used for Comorbidities Before Secukinumab Initiation Categorized by Type of Medication
Time frame: Baseline
Number of Most Frequent Medications Used for Comorbidities After Secukinumab Initiation Categorized by Type of Medication
Time frame: Up to approximately 84 months
Number of Medications Prescribed for AS, PsA, or PSO Before Secukinumab Initiation Categorized by Type of Medication
Time frame: Baseline
Number of Medications Prescribed for AS, PsA, or PSO After Secukinumab Initiation Categorized by Type of Medication
Time frame: Up to approximately 84 months
Duration of Primary Diagnosis
Time frame: Baseline
Duration of Secukinumab Treatment
Time frame: Up to approximately 84 months
Number of Patients per Secukinumab Use Category
Time frame: Up to approximately 84 months
Duration of Interruption of Secukinumab Treatment
Time frame: Up to approximately 84 months
Number of Patients who Used an Immunobiologic Before Secukinumab
Time frame: Baseline
Number of Patients who Tested Positive or Negative for Latent Tuberculosis Before Secukinumab Initiation
Time frame: Approximately 6 months
Number of Patients who Received Prophylactic Antibiotic Therapy Among Those who Tested Positive for Latent Tuberculosis Before Secukinumab Initiation
Time frame: Approximately 6 months
Number of Patients who Tested Positive or Negative for Latent Tuberculosis After Secukinumab Initiation
Time frame: Up to approximately 84 months
Number of Patients who Received Prophylactic Antibiotic Therapy Among Those who Tested Positive for Latent Tuberculosis After Secukinumab Initiation
Time frame: Up to approximately 84 months
Number of Patients not Tested for Tuberculosis Before Secukinumab Initiation With Prophylactic Antibiotic Use
Time frame: Approximately 6 months
Number of Patients Without a Tuberculosis Test Before Secukinumab Initiation
Time frame: Approximately 6 months
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by Novartis Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Active Tuberculosis Cases per 1000 Patient-years in Biologic Naive Patients Treated With Secukinumab (time frame: Up to approximately 84 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.