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Clinical Trials/NCT02530268
NCT02530268
Enrolling By Invitation
Not Applicable

Corrona Psoriatic Arthritis and Spondyloarthritis (PsA-SpA) Registry

CorEvitas0 sites5,000 target enrollmentMarch 1, 2013

Overview

Phase
Not Applicable
Intervention
Ankylosing Spondylitis
Conditions
Psoriatic Arthritis
Sponsor
CorEvitas
Enrollment
5000
Primary Endpoint
The major clinical outcomes include an assessment of the epidemiology of Spondyloarthritis; to better understand the presentation, natural history, management and outcomes.
Status
Enrolling By Invitation
Last Updated
2 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2013
End Date
December 1, 2100
Last Updated
2 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
CorEvitas
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • To be eligible for enrollment into the Corrona PsA-SpA Registry, a patient must satisfy all of the inclusion criteria and none of the

Exclusion Criteria

  • listed below.
  • Inclusion Criteria
  • The patient must be:
  • One of the following:
  • Diagnosed with psoriatic arthritis (PsA) and initiating (prescribed or starting) an eligible medication† for the treatment of PsA at the enrollment visit.
  • Meet the ASAS criteria for axial spondyloarthritis (AxSpA), including radiographic or non-radiographic, and initiating (prescribed or starting) an eligible biologic for the treatment of AxSpA at the enrollment visit.
  • Meet the modified New York classification criteria for ankylosing spondylitis (AS) and initiating (prescribed or starting) an eligible biologic for the treatment of AS at the enrollment visit
  • At least 18 years of age or older
  • Able and willing to provide written consent
  • Exclusion Criteria

Arms & Interventions

Ankylosing Spondylitis

Pts presenting to enrolling sites across the US are invited to enroll if eligible

Psoriatic Arthritis

Pts presenting to enrolling sites across the US are invited to enroll if eligible

Outcomes

Primary Outcomes

The major clinical outcomes include an assessment of the epidemiology of Spondyloarthritis; to better understand the presentation, natural history, management and outcomes.

Time Frame: A minimum of 10 years from last patient enrolled

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