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

Launched by COREVITAS · Aug 19, 2015

Keywords

ClinConnect Summary

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 ...

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Eligibility 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:
• 1. One of the following:
• • 1. Diagnosed with psoriatic arthritis (PsA) and initiating (prescribed or starting) an eligible medication† for the treatment of PsA at the enrollment visit.
• • 2. 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.
• • 3. 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
• • 2. At least 18 years of age or older
• • 3. Able and willing to provide written consent
• • Exclusion Criteria
• The patient must not be:
• • 1. Diagnosed with rheumatoid arthritis, systemic lupus erythematosus, or any other form of autoimmune inflammatory arthritis.
• • 2. Participating in or planning to participate in a clinical trial with an interventional research study of a non-marketed or marketed investigational drug (e.g. phase I-IV clinical drug trial, post marketing study or registry study where drug is being provided). Of note, concurrent participation in another observational registry study is not excluded. ∆
• • Once clinical trial participation has ended, a patient is permitted to enroll in the registry if they satisfy the eligibility requirements at the time of enrollment. If the patient participated in the PsA-SpA registry and was exited to join a clinical trial, the patient cannot be re-enrolled in the PsA-SpA registry after clinical trial participation has ended.
• • Patients switching from an originator biologic to a biosimilar satisfy the enrollment eligibility requirement.