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

NCT06666114 | Completed

• 1 other identifier: CAIN457FBR04
• Study Type: observational
• Target: 232
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis (PsO); Psoriatic Arthritis (PsA)

Outcome Measures

Primary Outcomes (5)

• Proportion of Patients With Disease-related Clinical Manifestations During 6 Months Before and 6 Months After Secukinumab Initiation

  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

  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

  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

  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

  Up to 6 months

Secondary Outcomes (16)

• Age

  Baseline

• Gender

  Baseline

• Ethnicity

  Baseline

• Time Since First PsA Symptoms

  Baseline

• Time Since First PsO Symptoms

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

São Paulo, CEP BR-04.636-900, Brazil

Location

MeSH Terms

Conditions

Psoriasis; Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 30, 2024
• Study Start: August 3, 2021
• Primary Completion: October 10, 2023
• Study Completion: October 10, 2023
• Last Updated: October 30, 2024

Record last verified: 2024-10

Locations

BR (1)