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Impact of Secukinumab on Clinical and Patient Reported Outcomes in Patients With Psoriasis

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Novartis

Status

Completed

Conditions

Psoriasis

Treatments

Drug: Secukinumab

Study type

Observational

Funder types

Industry

Identifiers

NCT05513014
CAIN457AUS31

Details and patient eligibility

About

The study was conducted to describe the demographics, disease characteristics, disease severity, comorbidities and patient reported outcomes at baseline and follow-up periods among adult patients diagnosed with PsO in CorEvitas' PsO Registry under routine medical care initiating secukinumab (SEC).

Full description

This is a retrospective analysis of a prospective observational cohort using CorEvitas' PsO registry of adult PsO patients. This study describes clinical and patient reported outcomes among adult patients initiating Secukinumab (SEC). Biologic experienced and naïve patients are examined separately. This study also describes changes in clinical and patient reported outcomes over time.

CorEvitas' Psoriasis Registry is a prospective, observational cohort of adult PsO patients starting systemic therapy, launched in April 2015 with sites in the US and Canada. Data collection occurs every ~6 months at routine dermatology visits. This study included US PsO patients who initiated secukinumab at or after enrollment and had a subsequent 6- and/or 12-month follow-up visit (Apr 2015 to Dec 2020).The index date is defined as the date of the first SEC initiation at or after enrollment.

Enrollment

1,518 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

The patient must:

  • Have been diagnosed with PsO by a dermatologist.
  • Be at least 18 years of age.
  • Be willing and able to provide written informed consent for participation in the registry.
  • Have started on or switched to an eligible systemic PsO treatment at enrollment1 or within the previous 12 months of the date of enrollment.

Exclusion criteria

  • Patient is participating in or planning to participate in an interventional clinical trial with a nonmarketed or marketed investigational drug (i.e. phase I-IV drug trial).

Trial design

1,518 participants in 3 patient groups

Secukinumab: Overall Cohort
Description:
Patients with Psoriasis who initiated Secukinumab
Treatment:
Drug: Secukinumab
Biologic Experienced
Description:
Patients who had the history of use of ≥1 biologic medication for the treatment of PsO at the time of SEC initiation
Biologic Naive
Description:
Patients who had no history of use of biologic medication for the treatment of PsO at the time of SEC initiation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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