An Analysis of the Improvement and Quality of Life Trends for UK/ROI Patients Treated With Cosentyx (Secukinumab) in a Retrospective Analysis of the BADBIR Data Source

NCT ID: NCT05368818

Last Updated: 2022-07-01

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

767 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-07

Study Completion Date

2021-05-06

Brief Summary

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This was a retrospective, observational study of psoriasis patients treated with secukinumab, using secondary data from BADBIR. BADBIR is a UK/ROI pharmacovigilance registry that was initiated in 2007 to monitor the long-term safety of biologic drugs used to treat psoriasis. The study used longitudinal data within the registry to track the trends relating to the disease. For the analysis of improvement and patient reported QoL, patients with a minimum of one follow-up visit were included. The index date was defined as the date of initiation of secukinumab treatment, and follow-up visits were at 6-, 12-, 18-, \& 24-months post-index.

Detailed Description

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The BADBIR data was current up until the 31st August 2019 for this analysis.

Study period: From 1st July 2015, as secukinumab was included in BADBIR in January 2016 and patients backdated 6 months, to 31st August 2019.

Identification period: From 1st July 2015 to 31st August 2019 was used to identify applicable patients for analysis.

Index date: Initiation of secukinumab treatment within the BADBIR database.

Conditions

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Plaque Psoriasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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All patients

Included all patients prescribed an on-label secukinumab dose

Secukinumab

Intervention Type OTHER

Included patients treated with Cosentyx (Secukinumab) in a retrospective analysis of the BADBIR data source

Patients with Psoriatic Arthritis (PsA)

Included patients classified as having a concomitant PsA diagnosis, if it was declared in the Baseline table

Secukinumab

Intervention Type OTHER

Included patients treated with Cosentyx (Secukinumab) in a retrospective analysis of the BADBIR data source

Interventions

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Secukinumab

Included patients treated with Cosentyx (Secukinumab) in a retrospective analysis of the BADBIR data source

Intervention Type OTHER

Other Intervention Names

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Cosentyx

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years at initiation of secukinumab.
* At least one follow-up visit post-registry enrollment.
* On-label dosing of secukinumab of 300mg.


* Age ≥18 years at initiation of secukinumab.
* At least one follow-up visit post-registry enrollment.
* On-label dosing of secukinumab of 300mg.
* Diagnosis of PsA at baseline.

Exclusion Criteria

\- The patient did not meet the criteria stated above.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 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 Investigative Site

East Hanover, New Jersey, United States

Site Status

Countries

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United States

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17932

Results for CAIN457AGB06 from the Novartis Clinical Trials Website

Other Identifiers

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CAIN457AGB06

Identifier Type: -

Identifier Source: org_study_id

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