PsoriasisNCT02707341
The CorEvitas Psoriasis (PSO) Registry
An observational study of Psoriasis, run by CorEvitas at 1 site in United States.
Trial summary
The primary objective of the CorEvitas Psoriasis Registry is to study the comparative safety of approved psoriasis therapies in a North American cohort of psoriasis subjects treated by dermatologists. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Dec 2100
- How long will I take part?
- 8 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 Psoriasis Registry during regularly-scheduled office visits. Selected dermatologists are invited to participate as investigators in the Registry. Physicians are selected carefully in an effort to ensure enrollment of subjects that represent a reasonable representation of a cross-section of the population throughout North America with Psoriasis. All potential sites are screened for clinical research experience and adherence to Good Clinical Practice (GCP) guidelines.
Who may be able to join
- The patient must:
- Have been diagnosed with psoriasis by a dermatologist.
- Be at least 18 years of age or older.
- Be willing and able to provide written consent for participation in the registry.
- Be willing and able to provide Personally Identifiable Information (PII) that includes the following types of personal information at a minimum: 1) Full Name and 2) Date of Birth.
- Meet one of the following criteria.
- Have started on or switched to a systemic psoriasis treatment within the previous 12 months†▲:
Who cannot join
- 1. Patient is participating in or planning to participate in a double-blind randomized of a psoriasis drug. Of note, concurrent participation in another observational registry or open-label Phase 3b/4 trial is not excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Study site
Waltham, Massachusetts, 02451
About this study
Official title: CorEvitas Psoriasis (PSO) Registry
The primary objective of the CorEvitas Psoriasis Registry is to study the comparative safety of approved psoriasis therapies in a North American cohort of psoriasis subjects treated by dermatologists. This includes assessing the incidence and nature of adverse events of special interest, including malignancy, in a real world population of psoriasis patients on new biologic therapies (e.g. secukinumab). Secondary objectives include analyzing the epidemiology and natural history of the disease, comorbidities, current treatment practices, and comparative effectiveness.
Read the detailed description
Based on the operating procedures established by the Corrona Rheumatoid Arthritis (RA) Registry, the Psoriasis Registry will use a parallel structure based on a design and strategy developed by Corrona, LLC. This registry will be cooperatively managed by scientific, operational, and quality leaders at Corrona and medical leaders appointed by the National Psoriasis Foundation (NPF).
Investigators may enroll patients who have started on or switched to a systemic agent for psoriasis within the previous twelve months. Currently approved subcutaneous biologics are indicated for adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The currently approved intravenous biologic agent is indicated for adult patients with chronic severe plaque psoriasis who are candidates for systemic therapy, and when other systemic therapies are medically less appropriate. All patients will receive standard of care treatments prescribed by the investigator, in accordance with the FDA-approved drug labeling, and all treatment decisions are the sole responsibility of the investigator.
This study will be conducted at approximately 200 sites across North America. Sites are assessed and selected through interviews with potential investigators and a corresponding site feasibility survey that includes information on the investigator's qualifications, previous research experience, and the availability of support staff, sub-investigators, and patient population.
The Corrona Psoriasis Registry is a longitudinal, observational study; therefore, the duration is indefinite with no pre-determined stop date. The enrollment period is estimated to take approximately four years, and subjects will be followed for a minimum of eight years beginning from the time the subject is enrolled.
The design is a prospective, multicenter, observational registry for subjects with psoriasis. Longitudinal follow-up data is obtained via Corrona Questionnaires completed by both subjects and their treating dermatologists (also known as "Providers" for a Corrona registry study) every 6 months (+/- 30 days). The registry is designed to collect data on patient demographics, smoking history, disease duration, disease severity, disease activity, history of prior psoriasis treatment, comorbidities, hospitalizations, adverse events of special interest, medication use, and laboratory results.
The registry is linked to external data sources including the Centers for Disease Control's National Death Index (NDI), the Centers for Medicare and Medicaid Services (CMS), and other administrative data sources to support drug safety monitoring and other research activities.
Any adverse events that are spontaneously volunteered by the subject or discovered as a result of general questioning by the investigator should be recorded on the Provider Follow-up Questionnaire for that visit.
- Conditions
- Psoriasis
- Keywords
- psoriasis, disease registry
- Medical subject headings
- Psoriasis
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 |
|---|---|---|
| Psoriasis | 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.
Number of patients with adverse events (AEs) or serious adverse events (SAEs).
Targeted events include malignancy, cardiovascular disease, serious infection, inflammatory bowel disease, gastrointestinal perforation, neurological events, hepatic events, and general serious adverse events.
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: A minimum of 8 years from last patient enrolled
Secondary outcomes (9)
Disease burden: Psoriatic area and severity index (PASI)
Measured: every 6 months for 8 years
Disease burden: Investigators Global Assessment (IGA)
Measured: every 6 months for 8 years
Disease burden: Body surface area (BSA)
Measured: every 6 months for 8 years
Percentage of patients with history of comorbidities
Measured: time frame: at registry enrollment
Physician reported: Fitzpatrick skin type
Measured: time frame: every 6 months for 8 years
Patient reported: EuroQOL-5D-3L
Measured: time frame: every 6 months for 8 years
Patient reported: Dermatology Quality of Life index (DLQI)
Measured: time frame: every 6 months for 8 years
Patient reported: Work productivity and Activity Impairment (WPAI)
Measured: time frame: every 6 months for 8 years
Patient reported: Pain, Fatigue, Itch score on Visual Analog Scale (VAS) (1-100)
Measured: time frame: every 6 months for 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study startApr 2015
- 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 (4)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies 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
- 10,000 participants (estimated)
- Target duration
- 8 Years
Sponsor and investigators
- Lead sponsor
- CorEvitas
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707341
- Sponsor's protocol ID
- CorEvitas-PSO-500
- Status last verified
- Aug 2026
- First submitted
- 4 May 2015
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Armstrong AW, Feldman SR, Fitzgerald T, Alkousakis T, Sima A, Li A, Kang HJ, Main SI, Khattri S, Stein Gold L. Patient-Reported Outcomes by Baseline Body Surface Area Involvement Among Individuals Initiating Biologic Therapy: Results from the CorEvitas Psoriasis Registry. Dermatol Ther (Heidelb). 2025 Aug;15(8):2117-2130. doi: 10.1007/s13555-025-01456-5. Epub 2025 Jun 11.
PubMed 40498388Strober B, Zhong Y, Sima A, Beeghly A, Eckmann T, Balagula E, Zhuo J, Lebwohl M. Criteria for Identifying Candidates for Systemic Psoriasis Treatment in the Real World: Application of the International Psoriasis Council Guidelines in Patients in North America. J Psoriasis Psoriatic Arthritis. 2024 Nov 21;10(1):22-27. doi: 10.1177/24755303241302070. eCollection 2025 Jan.
PubMed 39583219McLean RR, Sima AP, Beaty S, Jones EA, Eckmann T, Low R, McClung L, Spitzer RL, Stark J, Armstrong A. Durability of Near-Complete Skin Clearance in Patients with Psoriasis Using Systemic Biologic Therapies: Real-World Evidence from the CorEvitas Psoriasis Registry. Dermatol Ther (Heidelb). 2023 Nov;13(11):2753-2768. doi: 10.1007/s13555-023-01028-5. Epub 2023 Sep 27.
PubMed 37759099McLean RR, Sima AP, Beaty S, Low R, Spitzer RL, Stark JL, Lesser E, Lee E, Armstrong A. Skin Clearance is Associated with Reduced Treatment Failure in Patients with Psoriasis: Real-World Evidence from the CorEvitas Psoriasis Registry. Dermatol Ther (Heidelb). 2023 Nov;13(11):2739-2751. doi: 10.1007/s13555-023-01027-6. Epub 2023 Sep 27.
PubMed 37755689
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CorEvitas Psoriasis (PSO) Registry
- ClinicalTrials.gov ID
- NCT02707341
- Acronym / sponsor ID
- CorEvitas-PSO-500
- Conditions
- Psoriasis
- Keywords
- psoriasis, disease registry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- CorEvitasResearch network
- Study start
- Apr 2015
- Primary completion
- Dec 2100 (estimated)
- Study completion
- Dec 2100 (estimated)
- First posted
- 14 Mar 2016 (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.
The primary objective of the CorEvitas Psoriasis Registry is to study the comparative safety of approved psoriasis therapies in a North American cohort of psoriasis subjects treated by dermatologists. This includes assessing the incidence and nature of adverse events of special interest, including malignancy, in a real world population of psoriasis patients on new biologic therapies (e.g. secukinumab). Secondary objectives include analyzing the epidemiology and natural history of the disease, comorbidities, current treatment practices, and comparative effectiveness.
Detailed description
Based on the operating procedures established by the Corrona Rheumatoid Arthritis (RA) Registry, the Psoriasis Registry will use a parallel structure based on a design and strategy developed by Corrona, LLC. This registry will be cooperatively managed by scientific, operational, and quality leaders at Corrona and medical leaders appointed by the National Psoriasis Foundation (NPF).
Investigators may enroll patients who have started on or switched to a systemic agent for psoriasis within the previous twelve months. Currently approved subcutaneous biologics are indicated for adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The currently approved intravenous biologic agent is indicated for adult patients with chronic severe plaque psoriasis who are candidates for systemic therapy, and when other systemic therapies are medically less appropriate. All patients will receive standard of care treatments prescribed by the investigator, in accordance with the FDA-approved drug labeling, and all treatment decisions are the sole responsibility of the investigator.
This study will be conducted at approximately 200 sites across North America. Sites are assessed and selected through interviews with potential investigators and a corresponding site feasibility survey that includes information on the investigator's qualifications, previous research experience, and the availability of support staff, sub-investigators, and patient population.
The Corrona Psoriasis Registry is a longitudinal, observational study; therefore, the duration is indefinite with no pre-determined stop date. The enrollment period is estimated to take approximately four years, and subjects will be followed for a minimum of eight years beginning from the time the subject is enrolled.
The design is a prospective, multicenter, observational registry for subjects with psoriasis. Longitudinal follow-up data is obtained via Corrona Questionnaires completed by both subjects and their treating dermatologists (also known as "Providers" for a Corrona registry study) every 6 months (+/- 30 days). The registry is designed to collect data on patient demographics, smoking history, disease duration, disease severity, disease activity, history of prior psoriasis treatment, comorbidities, hospitalizations, adverse events of special interest, medication use, and laboratory results.
The registry is linked to external data sources including the Centers for Disease Control's National Death Index (NDI), the Centers for Medicare and Medicaid Services (CMS), and other administrative data sources to support drug safety monitoring and other research activities.
Any adverse events that are spontaneously volunteered by the subject or discovered as a result of general questioning by the investigator should be recorded on the Provider Follow-up Questionnaire for that visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psoriasis | – | –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 Psoriasis Registry during regularly-scheduled office visits. Selected dermatologists are invited to participate as investigators in the Registry. Physicians are selected carefully in an effort to ensure enrollment of subjects that represent a reasonable representation of a cross-section of the population throughout North America with Psoriasis. All potential sites are screened for clinical research experience and adherence to Good Clinical Practice (GCP) guidelines.
Key inclusion criteria (7 listed)
- Have been diagnosed with psoriasis by a dermatologist.
- Be at least 18 years of age or older.
- Be willing and able to provide written consent for participation in the registry.
- Be willing and able to provide Personally Identifiable Information (PII) that includes the following types of personal information at a minimum: 1) Full Name and 2) Date of Birth.
- Meet one of the following criteria.
Key exclusion criteria (1 listed)
- 1. Patient is participating in or planning to participate in a double-blind randomized of a psoriasis drug. Of note, concurrent participation in another observational registry or open-label Phase 3b/4 trial is not excluded.
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
Number of patients with adverse events (AEs) or serious adverse events (SAEs).
Time frame: A minimum of 8 years from last patient enrolled
Targeted events include malignancy, cardiovascular disease, serious infection, inflammatory bowel disease, gastrointestinal perforation, neurological events, hepatic events, and general serious adverse events. An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
9 secondary outcomes
Disease burden: Psoriatic area and severity index (PASI)
Time frame: every 6 months for 8 years
Disease burden: Investigators Global Assessment (IGA)
Time frame: every 6 months for 8 years
Disease burden: Body surface area (BSA)
Time frame: every 6 months for 8 years
Percentage of patients with history of comorbidities
Time frame: time frame: at registry enrollment
Physician reported: Fitzpatrick skin type
Time frame: time frame: every 6 months for 8 years
Patient reported: EuroQOL-5D-3L
Time frame: time frame: every 6 months for 8 years
Patient reported: Dermatology Quality of Life index (DLQI)
Time frame: time frame: every 6 months for 8 years
Patient reported: Work productivity and Activity Impairment (WPAI)
Time frame: time frame: every 6 months for 8 years
Patient reported: Pain, Fatigue, Itch score on Visual Analog Scale (VAS) (1-100)
Time frame: time frame: every 6 months for 8 years
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 27 Aug 2026.
- Derived from this study: PubMed 40498388Armstrong AW, Feldman SR, Fitzgerald T, Alkousakis T, Sima A, Li A, Kang HJ, Main SI, Khattri S, Stein Gold L. Patient-Reported Outcomes by Baseline Body Surface Area Involvement Among Individuals Initiating Biologic Therapy: Results from the CorEvitas Psoriasis Registry. Dermatol Ther (Heidelb). 2025 Aug;15(8):2117-2130. doi: 10.1007/s13555-025-01456-5. Epub 2025 Jun 11.
- Derived from this study: PubMed 39583219Strober B, Zhong Y, Sima A, Beeghly A, Eckmann T, Balagula E, Zhuo J, Lebwohl M. Criteria for Identifying Candidates for Systemic Psoriasis Treatment in the Real World: Application of the International Psoriasis Council Guidelines in Patients in North America. J Psoriasis Psoriatic Arthritis. 2024 Nov 21;10(1):22-27. doi: 10.1177/24755303241302070. eCollection 2025 Jan.
- Derived from this study: PubMed 37759099McLean RR, Sima AP, Beaty S, Jones EA, Eckmann T, Low R, McClung L, Spitzer RL, Stark J, Armstrong A. Durability of Near-Complete Skin Clearance in Patients with Psoriasis Using Systemic Biologic Therapies: Real-World Evidence from the CorEvitas Psoriasis Registry. Dermatol Ther (Heidelb). 2023 Nov;13(11):2753-2768. doi: 10.1007/s13555-023-01028-5. Epub 2023 Sep 27.
- Derived from this study: PubMed 37755689McLean RR, Sima AP, Beaty S, Low R, Spitzer RL, Stark JL, Lesser E, Lee E, Armstrong A. Skin Clearance is Associated with Reduced Treatment Failure in Patients with Psoriasis: Real-World Evidence from the CorEvitas Psoriasis Registry. Dermatol Ther (Heidelb). 2023 Nov;13(11):2739-2751. doi: 10.1007/s13555-023-01027-6. Epub 2023 Sep 27.
- CorEvitas home pageLink provided by the sponsor.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by CorEvitas at 1 site in United States.
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 1 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: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Psoriasis Registry Team (6178655932, ppd_corepsoriasis@thermofisher.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with adverse events (AEs) or serious adverse events (SAEs). (time frame: A minimum of 8 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 NCT02707341, which also lists 4 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 27 Aug 2026.