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Clinical Trials/NCT06172426
NCT06172426
Completed
Not Applicable

Incidence of Psoriatic Arthritis Among Psoriasis Patients Newly Initiated With Secukinumab in a US Claims Database and a UK Registry

Novartis Pharmaceuticals1 site in 1 country1,171 target enrollmentNovember 17, 2022
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ConditionsPsoriatic ArthritisPsoriasis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Psoriatic Arthritis
Sponsor
Novartis Pharmaceuticals
Enrollment
1171
Locations
1
Primary Endpoint
Exposure-adjusted incidence rate of PsA per 100 patient-years among PsO patients who newly initiated secukinumab
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This was a retrospective cohort study to assess the incidence rate of psoriatic arthritis (PsA) among psoriasis (PsO) patients newly initiated on secukinumab or any biologics/apremilast (small molecule). The analysis was performed in two databases, IBM® MarketScan® database: Commercial Claims and Encounters (CCAE) and Medicare Supplemental Beneficiaries (MDCR) from 01 January 2010 to 30 June 2021 and BADBIR from 01 January 2016 to 01 September 2021.

Registry
clinicaltrials.gov
Start Date
November 17, 2022
End Date
December 7, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Exposure-adjusted incidence rate of PsA per 100 patient-years among PsO patients who newly initiated secukinumab

Time Frame: Up to 11.5 years

Secondary Outcomes

  • Health Assessment Questionnaires - Disability Index (HAQ-DI)(Baseline)
  • Ethnicity(Baseline)
  • Height(Baseline)
  • Prior treatments(Baseline)
  • Psoriasis Area and Severity Index (PASI)(Baseline)
  • Weight(Baseline)
  • Body mass index (BMI)(Baseline)
  • Comorbidities(Baseline)
  • Time from secukinumab initiation to the first PsA diagnosis(Up to 11.5 years)
  • Age(Baseline)
  • Gender(Baseline)
  • Region(Baseline)
  • Insurance type(Baseline)
  • Hard-to-treat locations(Baseline)
  • Dermatology Life Quality Index (DLQI)(Baseline)
  • Body Surface Area (BSA)(Baseline)

Study Sites (1)

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