Psoriatic Disease and Related Manifestations; Real World Evidence in Brazilian Secukinumab Environment

NCT ID: NCT06666114

Last Updated: 2024-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

232 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-03

Study Completion Date

2023-10-10

Brief Summary

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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.

Detailed Description

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Conditions

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Psoriasis (PsO) Psoriatic Arthritis (PsA)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis

São Paulo, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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CAIN457FBR04

Identifier Type: -

Identifier Source: org_study_id

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