Psoriasis (PsO)NCT06666114
Psoriatic Disease and Related Manifestations; Real World Evidence in Brazilian Secukinumab Environment
An observational study of Psoriasis (PsO) and Psoriatic Arthritis (PsA), run by Novartis Pharmaceuticals at 1 site in Brazil.
Trial summary
This was a retrospective observational study that relied on data extracted from patient chart review at the participating sites. At least 12 months of patient data was verified, comprising at least 6 months (pre-period) and 6 months (post-period) after secukinumab initiation (index date). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis (PsO), Psoriatic Arthritis (PsA)
- How many people
- 232 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Aug 2021to 10 Oct 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
- Adult patients aged ≥18 years at index date.
- Patients with PsO diagnosed with PsA (concomitant or sequentially), either by a rheumatologist or dermatologist, at least 6 months prior to initiation of secukinumab treatment.
- Continuously treated with secukinumab for at least 24 weeks (6 months) after index date.
- Medical history available from at least the one-year study period (at least 6 months previous to the start of secukinumab treatment and at least 6 months after).
Who cannot join
- Patients who interrupted secukinumab treatment for 3 or more months during the 6-month period (post-period) for any cause.
- Patients known to be participating in an interventional study at any point of the one-year study period.
Trial locations and contacts
1 site in 1 country.
About this study
This was a retrospective observational study that relied on data extracted from patient chart review at the participating sites. At least 12 months of patient data was verified, comprising at least 6 months (pre-period) and 6 months (post-period) after secukinumab initiation (index date). All data extracted from patient charts was entered into an electronic case report form (eCRF), specifically designed to capture all variables needed for the study data analysis.
- Conditions
- Psoriasis (PsO), Psoriatic Arthritis (PsA)
- Medical subject headings
- Psoriasis, Arthritis, Psoriatic
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients With Disease-related Clinical Manifestations During 6 Months Before and 6 Months After Secukinumab Initiation
Measured: Up to 1 year
Proportion of Patients With Disease-related Clinical Manifestations During 6 Months Before Secukinumab Introduction Who Experienced Reduced or Eliminated Manifestations During 6 Months of Secukinumab Treatment
Measured: Up to 1 year
Proportion of Patients With Disease-related Clinical Manifestations During 6 Months Before Secukinumab Introduction Who Experienced Increased Clinical Manifestations During 6 Months of Secukinumab Treatment
Measured: Up to 1 year
Proportion of Patients With Disease-related Clinical Manifestations at the Time of Secukinumab Introduction Who Experienced Reduced or Eliminated Manifestations During 6 Months of Secukinumab Treatment
Measured: Up to 6 months
Proportion of Patients With Disease-related Clinical Manifestations at the Time of Secukinumab Introduction Who Experienced Increased Manifestations During 6 Months of Secukinumab Treatment
Measured: Up to 6 months
Secondary outcomes (16)
Age
Measured: Baseline
Gender
Measured: Baseline
Ethnicity
Measured: Baseline
Time Since First PsA Symptoms
Measured: Baseline
Time Since First PsO Symptoms
Measured: Baseline
Proportion of Patients With Disease-related Clinical Manifestations at Diagnosis
Measured: Baseline
Proportion of Patients per Screening Tool Used for PsA and PsO Diagnosis
PsA and PsO screening tools included Psoriasis Area and Severity Index (PASI), Body Surface Area (BSA), Dermatology Life Quality Index (DLQI), Disease activity in PsA (DAPSA), and Health Assessment Questionnaire Disability Index (HAQ-DI).
Measured: Up to 1 year
Psoriasis Area and Severity Index (PASI)
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease).
Measured: Up to 1 year
Body Surface Area (BSA)
Measured: Up to 1 year
Dermatology Life Quality Index (DLQI)
The DLQI is a validated, 10-question, self-reported questionnaire to evaluate the patient's perception of the impact of skin disease on quality of life. The DLQI is rated on a 4-point scale (0 = not at all to 3 = very much). The highest possible total score for the DLQI is 30, and higher scores indicate more severe impact on quality of life.
Measured: Up to 1 year
Disease activity in PsA (DAPSA)
The Disease Activity Index for Psoriatic Arthritis (DAPSA) is a tool used to measure PsA activity: remission (0-4); low disease activity (5-14); moderate disease activity (15-28); high disease activity (>28).
Measured: Up to 1 year
Health Assessment Questionnaire Disability Index (HAQ-DI)
The HAQ-DI is a 20-question scale assessing functional ability. The final HAQ-DI score ranges from 0 (no problems functioning) to 3 (not able to function).
Measured: Up to 1 year
Proportion of Patients per Treatment History Prior to Secukinumab Initiation
Measured: Up to 6 months
Proportion of Patients per Line of treatment (LOT) of PsA/PsO-target Treatment Before Secukinumab Initiation
Measured: Up to 6 months
Proportion of Patients With Disease-related Clinical Manifestations per Biologic Naïve and Non-biologic Naïve Patients, Categorized by Disease Severity
Measured: Up to 6 months
Proportion of Patients With Concomitant Medications, per Category
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start3 Aug 2021
- Primary completion10 Oct 2023
- Study completion10 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis (PsO)Studies 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
- 232 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
- NCT06666114
- Sponsor's protocol ID
- CAIN457FBR04
- Status last verified
- Oct 2024
- First submitted
- 29 Oct 2024
- Last updated
- 30 Oct 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psoriatic Disease and Related Manifestations; Real World Evidence in Brazilian Secukinumab Environment
- ClinicalTrials.gov ID
- NCT06666114
- Acronym / sponsor ID
- CAIN457FBR04
- Conditions
- Psoriasis (PsO), Psoriatic Arthritis (PsA)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 30 Oct 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 chart review at the participating sites. At least 12 months of patient data was verified, comprising at least 6 months (pre-period) and 6 months (post-period) after secukinumab initiation (index date). All data extracted from patient charts was entered into an electronic case report form (eCRF), specifically designed to capture all variables needed for the study data analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
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)
- Adult patients aged ≥18 years at index date.
- Patients with PsO diagnosed with PsA (concomitant or sequentially), either by a rheumatologist or dermatologist, at least 6 months prior to initiation of secukinumab treatment.
- Continuously treated with secukinumab for at least 24 weeks (6 months) after index date.
- Medical history available from at least the one-year study period (at least 6 months previous to the start of secukinumab treatment and at least 6 months after).
Key exclusion criteria (2 listed)
- Patients who interrupted secukinumab treatment for 3 or more months during the 6-month period (post-period) for any cause.
- Patients known to be participating in an interventional study at any point of the one-year 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
Proportion of Patients With Disease-related Clinical Manifestations During 6 Months Before and 6 Months After Secukinumab Initiation
Time frame: Up to 1 year
Proportion of Patients With Disease-related Clinical Manifestations During 6 Months Before Secukinumab Introduction Who Experienced Reduced or Eliminated Manifestations During 6 Months of Secukinumab Treatment
Time frame: Up to 1 year
Proportion of Patients With Disease-related Clinical Manifestations During 6 Months Before Secukinumab Introduction Who Experienced Increased Clinical Manifestations During 6 Months of Secukinumab Treatment
Time frame: Up to 1 year
Proportion of Patients With Disease-related Clinical Manifestations at the Time of Secukinumab Introduction Who Experienced Reduced or Eliminated Manifestations During 6 Months of Secukinumab Treatment
Time frame: Up to 6 months
Proportion of Patients With Disease-related Clinical Manifestations at the Time of Secukinumab Introduction Who Experienced Increased Manifestations During 6 Months of Secukinumab Treatment
Time frame: Up to 6 months
16 secondary outcomes
Age
Time frame: Baseline
Gender
Time frame: Baseline
Ethnicity
Time frame: Baseline
Time Since First PsA Symptoms
Time frame: Baseline
Time Since First PsO Symptoms
Time frame: Baseline
Proportion of Patients With Disease-related Clinical Manifestations at Diagnosis
Time frame: Baseline
Proportion of Patients per Screening Tool Used for PsA and PsO Diagnosis
Time frame: Up to 1 year
Psoriasis Area and Severity Index (PASI)
Time frame: Up to 1 year
Body Surface Area (BSA)
Time frame: Up to 1 year
Dermatology Life Quality Index (DLQI)
Time frame: Up to 1 year
Disease activity in PsA (DAPSA)
Time frame: Up to 1 year
Health Assessment Questionnaire Disability Index (HAQ-DI)
Time frame: Up to 1 year
Proportion of Patients per Treatment History Prior to Secukinumab Initiation
Time frame: Up to 6 months
Proportion of Patients per Line of treatment (LOT) of PsA/PsO-target Treatment Before Secukinumab Initiation
Time frame: Up to 6 months
Proportion of Patients With Disease-related Clinical Manifestations per Biologic Naïve and Non-biologic Naïve Patients, Categorized by Disease Severity
Time frame: Up to 6 months
Proportion of Patients With Concomitant Medications, per Category
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 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 Psoriasis (PsO) and Psoriatic Arthritis (PsA), run by Novartis Pharmaceuticals at 1 site in Brazil.
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 2 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: finished, as of the sponsor's last update on 30 Oct 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 Brazil. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of Patients With Disease-related Clinical Manifestations During 6 Months Before and 6 Months After Secukinumab Initiation (time frame: Up to 1 year). The study lists 5 primary outcomes in all. 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 30 Oct 2024.