Clinical trial NCT02530268: The Corrona Psoriatic Arthritis and Spondyloarthritis (PsA-SpA) Registry
Official title: Corrona Psoriatic Arthritis and Spondyloarthritis (PsA-SpA) Registry
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Psoriatic Arthritis
Spondyloarthritis
Keywords: psoriatic arthritis
spondyloarthritis
disease registry
Lead sponsor: CorEvitas
Sponsor class: NETWORK
First posted: 2015-08-21
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are enrolled in the Psoriatic Arthritis and Spondyloarthritis Registry during regularly scheduled office visits. Selected rheumatologists are invited to participate as investigators in the Registry.

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.

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.

Primary outcomes:
measure: The major clinical outcomes include an assessment of the epidemiology of Spondyloarthritis; to better understand the presentation, natural history, management and outcomes.
timeFrame: A minimum of 10 years from last patient enrolled
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CorEvitas
name: Jeffrey Greenberg, MD, MPH
role: STUDY_DIRECTOR
References:
citation: Mease PJ, Accortt NA, Rebello S, Etzel CJ, Harrison RW, Aras GA, Gharaibeh MMF, Greenberg JD, Collier DH. Persistence of tumor necrosis factor inhibitor or conventional synthetic disease-modifying antirheumatic drug monotherapy or combination therapy in psoriatic arthritis in a real-world setting. Rheumatol Int. 2019 Sep;39(9):1547-1558. doi: 10.1007/s00296-019-04345-1. Epub 2019 Jul 18.