The Corrona Psoriatic Arthritis and Spondyloarthritis (PsA-SpA) Registry

• Conditions: Psoriatic Arthritis; Spondyloarthritis

• Registration Number: NCT02530268
• Lead Sponsor: CorEvitas

Brief Summary

This prospective, non-interventional, research registry is designed to study the comparative effectiveness and comparative safety of approved treatments for PsA-SpA in a cohort of patients cared for by rheumatologists across North America. Secondary objectives include analyzing the epidemiology and natural history of the disease, its comorbidities, and current treatment practices.

Detailed Description

There is a significant unmet need to develop clinical registry data on the presentation, natural history, management, and outcomes of PsA-SpA. There is no large clinical registry of PsA-SpA patients seen in general rheumatology practices. It is anticipated that Corrona's registry will supplement information gathered in other programs and potentially represent a more general rheumatology spectrum of PsA-SpA patients representative of the general population.

The primary objective of the registry is to prospectively study the comparative effectiveness and comparative safety of therapies in a national cohort of PsA-SpA patients being cared for by rheumatologists. Secondary objectives include analyzing the epidemiology and natural history of the disease group, comorbidities, and current treatment practices.

The design is a prospective, non-interventional, observational registry for patients with PsA or SpA under the care of a licensed rheumatologist. Longitudinal follow-up data is collected from both patients and their treating rheumatologists during routine clinical encounters using Corrona registry questionnaires. These questionnaires collect data on patient demographics, disease duration, medical history (including all prior and current treatments for PsA-SpA), smoking status, alcohol use, disease severity, pain, activity, and other clinical effectiveness measures, patient reported outcomes, comorbidities, hospitalizations, and other targeted safety outcomes, including pregnancy.

After the enrollment visit, SpA patients and physicians will complete follow-up questionnaires during regularly scheduled clinical encounters. The goal is to collect data from patients and providers at six month intervals, not to exceed 2 visits in any 12 month period.

Adverse events may be volunteered spontaneously by the subject, or be discovered as a result of general questioning by the Principal Investigator. During all Corrona related visits with the Principal Investigator, subjects will be questioned regarding the occurrence of adverse events.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2015-05-01
• Study First Submitted QC: 2015-08-19
• Study First Posted: 2015-08-21
• Status Verified: 2022-11
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04
• Primary Completion: 2100-12
• Study Completion: 2100-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The major clinical outcomes include an assessment of the epidemiology of Spondyloarthritis; to better understand the presentation, natural history, management and outcomes.	A minimum of 10 years from last patient enrolled