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

NCT ID: NCT05513014

Last Updated: 2022-11-08

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

1518 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-21

Study Completion Date

2021-08-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Psoriasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Secukinumab: Overall Cohort

Patients with Psoriasis who initiated Secukinumab

Secukinumab

Intervention Type DRUG

Patients with Psoriasis who initiated Secukinumab

Biologic Experienced

Patients who had the history of use of ≥1 biologic medication for the treatment of PsO at the time of SEC initiation

No interventions assigned to this group

Biologic Naive

Patients who had no history of use of biologic medication for the treatment of PsO at the time of SEC initiation

No interventions assigned to this group

Interventions

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Secukinumab

Patients with Psoriasis who initiated Secukinumab

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 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 Pharmaceuticals

East Hanover, New Jersey, United States

Site Status

Countries

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United States

Related Links

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http://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17969

Results for CAIN457AUS31 from the Novartis Clinical Trials Website

Other Identifiers

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CAIN457AUS31

Identifier Type: -

Identifier Source: org_study_id

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