Clinical trial NCT06666114: Psoriatic Disease and Related Manifestations; Real World Evidence in Brazilian Secukinumab Environment
Official title: Psoriatic Disease and Related Manifestations; Real World Evidence in Brazilian Secukinumab Environment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis (PsO)
Psoriatic Arthritis (PsA)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-10-30
Enrollment: 232
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 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.


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Proportion of Patients With Disease-related Clinical Manifestations During 6 Months Before and 6 Months After Secukinumab Initiation
timeFrame: Up to 1 year
measure: 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
timeFrame: Up to 1 year
measure: 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
timeFrame: Up to 1 year
measure: 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
timeFrame: Up to 6 months
measure: Proportion of Patients With Disease-related Clinical Manifestations at the Time of Secukinumab Introduction Who Experienced Increased Manifestations During 6 Months of Secukinumab Treatment
timeFrame: Up to 6 months
Secondary outcomes:
measure: Age
timeFrame: Baseline
measure: Gender
timeFrame: Baseline
measure: Ethnicity
timeFrame: Baseline
measure: Time Since First PsA Symptoms
timeFrame: Baseline
measure: Time Since First PsO Symptoms
timeFrame: Baseline
measure: Proportion of Patients With Disease-related Clinical Manifestations at Diagnosis
timeFrame: Baseline
measure: Proportion of Patients per Screening Tool Used for PsA and PsO Diagnosis
timeFrame: Up to 1 year
measure: Psoriasis Area and Severity Index (PASI)
timeFrame: Up to 1 year
measure: Body Surface Area (BSA)
timeFrame: Up to 1 year
measure: Dermatology Life Quality Index (DLQI)
timeFrame: Up to 1 year
measure: Disease activity in PsA (DAPSA)
timeFrame: Up to 1 year
measure: Health Assessment Questionnaire Disability Index (HAQ-DI)
timeFrame: Up to 1 year
measure: Proportion of Patients per Treatment History Prior to Secukinumab Initiation
timeFrame: Up to 6 months
measure: Proportion of Patients per Line of treatment (LOT) of PsA/PsO-target Treatment Before Secukinumab Initiation
timeFrame: Up to 6 months
measure: Proportion of Patients With Disease-related Clinical Manifestations per Biologic Naïve and Non-biologic Naïve Patients, Categorized by Disease Severity
timeFrame: Up to 6 months
measure: Proportion of Patients With Concomitant Medications, per Category
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Novartis
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: