Psoriatic ArthritisNCT02530268
The Corrona Psoriatic Arthritis and Spondyloarthritis (PsA-SpA) Registry
An observational study of Psoriatic Arthritis and Spondyloarthritis, run by CorEvitas.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis, Spondyloarthritis
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Dec 2100
- How long will I take part?
- 15 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- The patient must not be:
- Diagnosed with rheumatoid arthritis, systemic lupus erythematosus, or any other form of autoimmune inflammatory arthritis.
- 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.
About this study
Official title: Corrona Psoriatic Arthritis and Spondyloarthritis (PsA-SpA) Registry
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.
Read the 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.
- Conditions
- Psoriatic Arthritis, Spondyloarthritis
- Keywords
- psoriatic arthritis, spondyloarthritis, disease registry
- Medical subject headings
- Arthritis, Psoriatic, Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The major clinical outcomes include an assessment of the epidemiology of Spondyloarthritis; to better understand the presentation, natural history, management and outcomes.
Measured: A minimum of 10 years from last patient enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2015 (estimated)
- Study startMar 2013
- Primary completionDec 2100 (estimated)
- Study completionDec 2100 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- CorEvitas
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jeffrey Greenberg, MD, MPH, Study director, CorEvitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530268
- Sponsor's protocol ID
- Corrona-PSA-400
- Status last verified
- Jan 2026
- First submitted
- 1 May 2015
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Mease PJ, Blachley T, Malatestinic WN, Harrold LR, Dube B, Lisse JR, Bolce RJ, Hunter TM. Effectiveness of bDMARDs in ankylosing spondylitis patients by biologic use: experience from the CorEvitas PsA/SpA Registry. Curr Med Res Opin. 2024 Feb;40(2):315-323. doi: 10.1080/03007995.2023.2291160. Epub 2024 Jan 24.
PubMed 38050693Mease PJ, Ogdie A, Tesser J, Shiff NJ, Lin I, Chakravarty SD, Kelleman M, Dodge R, McLean RR, Broadwell A, Kavanaugh A, Merola JF. Six-Month Persistence and Multi-domain Effectiveness of Guselkumab in Adults with Psoriatic Arthritis: Real-World Data from the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry. Rheumatol Ther. 2023 Dec;10(6):1479-1501. doi: 10.1007/s40744-023-00582-w. Epub 2023 Aug 19.
PubMed 37597159Mease 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.
PubMed 31321485
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corrona Psoriatic Arthritis and Spondyloarthritis (PsA-SpA) Registry
- ClinicalTrials.gov ID
- NCT02530268
- Acronym / sponsor ID
- Corrona-PSA-400
- Conditions
- Psoriatic Arthritis, Spondyloarthritis
- Keywords
- psoriatic arthritis, spondyloarthritis, disease registry
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- CorEvitasResearch network
- Study start
- Mar 2013
- Primary completion
- Dec 2100 (estimated)
- Study completion
- Dec 2100 (estimated)
- First posted
- 21 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- One of the following:
- At least 18 years of age or older
- Able and willing to provide written consent
Key exclusion criteria (5 listed)
- Diagnosed with rheumatoid arthritis, systemic lupus erythematosus, or any other form of autoimmune inflammatory arthritis.
- 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. ∆
- Patients switching from an originator biologic to a biosimilar satisfy the enrollment eligibility requirement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Derived from this study: PubMed 38050693Mease PJ, Blachley T, Malatestinic WN, Harrold LR, Dube B, Lisse JR, Bolce RJ, Hunter TM. Effectiveness of bDMARDs in ankylosing spondylitis patients by biologic use: experience from the CorEvitas PsA/SpA Registry. Curr Med Res Opin. 2024 Feb;40(2):315-323. doi: 10.1080/03007995.2023.2291160. Epub 2024 Jan 24.
- Derived from this study: PubMed 37597159Mease PJ, Ogdie A, Tesser J, Shiff NJ, Lin I, Chakravarty SD, Kelleman M, Dodge R, McLean RR, Broadwell A, Kavanaugh A, Merola JF. Six-Month Persistence and Multi-domain Effectiveness of Guselkumab in Adults with Psoriatic Arthritis: Real-World Data from the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry. Rheumatol Ther. 2023 Dec;10(6):1479-1501. doi: 10.1007/s40744-023-00582-w. Epub 2023 Aug 19.
- Derived from this study: PubMed 31321485Mease 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.
- CorEvitas home pageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeffrey Greenberg, MD, MPH study director
CorEvitas
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriatic Arthritis and Spondyloarthritis, run by CorEvitas.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02530268, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.