PsoriasisRRFNCT02413801
Serum, Cellular and Imaging Markers of Arthritis in Psoriasis Patients
An observational study of Psoriasis, run by University of Rochester at 1 site in United States.
Trial summary
The events that underlie the conversion from Psoriasis to Psoriatic Arthritis (PsA) are not well understood. This conversion occurs 30% of the time within the first 10 years of psoriasis diagnosis. PsA patients have about a 50% chance of developing joint damage within the first 2 years of disease. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2015to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male and female subjects that are 18 years old and older. Due to the demographic distribution of the disease we expect all or nearly all subjects to be Caucasian, however no subjects will be excluded from any group based on race or ethnic origin.
Who may be able to join
- All Subjects
- Ability to provide written informed consent
- Subjects must be 18 years old or older
- Psoriasis Subjects
- Patients with self-diagnosed Psoriasis. These subjects may present with thick, scaly, silvery and/or red skin, without ever having been diagnosed by a dermatologist:
- Starting either a DMARD or biologic standard of care for their psoriasis OR
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- Currently started taking a DMARD within the last two weeks of study visit procedures OR
- Currently not using a DMARD or biologic treatment, subjects may be using topical creams or UV therapy
- Willing to be studied longitudinally with a 4 month follow-up blood draw and PDUS if initial PDUS demonstrates positive findings.
- Bone Marrow Aspiration:
- Willing to undergo procedure.
- Psoriasis: positive findings on Power Doppler Ultra Sound (PDUS+) such as joint erosion, effusion, synovitis or increased vascularity, otherwise known as a signal.
Who cannot join
- All Subjects
- Unable to donate blood because of poor venous access or intolerance of phlebotomy.
- Chronic pain syndrome, autoimmune or active inflammatory conditions other than the conditions being studied. (i.e., chronic infection with hepatitis B or hepatitis C, inflammatory arthritis, etc) which in the investigator's opinion may confound the study results.
- Healthy subjects:
- Musculoskeletal conditions such as joint pains or swelling, fracture, tendonitis or trauma in the past 3 months, gout, or any arthritis which in the investigator's opinion may confound the study results.
- Illness in the last month which in the investigator's opinion may confound the study results.
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- Taking systemic steroids or immunosuppressants
- Psoriasis Subjects:
- Evidence of inflammatory arthritis.
- Psoriatic Arthritis Screening and Evaluation (PASE) questionnaire score greater than or equal to 47.
- Meet CASPAR criteria for PsA.
- Bone Marrow Aspiration:
- Side effect to local anesthetics such as lidocaine or novocain.
- Bleeding disorders or conditions requiring treatment with, NSAID, aspirin, anti-coagulants or anti-platelet agent, unless a physician investigator determines it to be safe to hold these agents for 2 weeks.
- Known thrombocytopenia (< 100,000) or clinically significant PT or PTT outside the normal range.
- Pregnant women should not participate; Pregnancy tests will not be performed.
Trial locations and contacts
1 site in 1 country.
About this study
The events that underlie the conversion from Psoriasis to Psoriatic Arthritis (PsA) are not well understood. This conversion occurs 30% of the time within the first 10 years of psoriasis diagnosis. PsA patients have about a 50% chance of developing joint damage within the first 2 years of disease. A biomarker that identifies subclinical joint inflammation in psoriasis patients would allow for a diagnostic tool to allow for earlier intervention in psoriasis patients and provide a better understanding of the underlying molecular pathogenesis that may lead to development of new therapeutic targets in PsA.
Read the detailed description
Our long-term goals are to: 1) develop arthritis biomarkers in psoriasis patients that will facilitate early treatment interventions; and, 2) identify new therapeutic targets in PsA through better understanding of the underlying molecular pathogenesis. PsA, an inflammatory arthritis associated with psoriasis, affects approximately 650,000 adults in the United States and is associated with increased morbidity and mortality. Joint inflammation and damage arise within the first 2 years of disease in 50% of patients who manifest bone erosions and joint space narrowing on plain x-rays. The advent of Tumor Necrosis Factor antagonists (TNFi) for treatment of PsA has dramatically improved clinical response and slowed bone and cartilage degradation. Nevertheless, up to 45% of patients do not meet primary endpoints in clinical trials, which underscores the need for new therapeutic options.
Another approach to improve treatment response is early PsA diagnosis, and recent data indicate that treatment soon after disease onset can improve outcomes. Relevant to the potential for early intervention and prevention, psoriatic skin plaques typically precede PsA by 10 years. Moreover, a significant percentage of these psoriasis patients have subclinical musculoskeletal imaging findings. These findings provide an unparalleled opportunity for early intervention that could potentially limit or halt joint inflammation and damage. Regrettably, despite the obvious advantages of early diagnosis and treatment, this goal remains elusive because the clinical significance of imaging abnormalities in psoriasis remains unknown. Furthermore, investigators have limited understanding of the mechanisms that underlie the transition from psoriasis to PsA, and investigators lack the disease specific biomarkers necessary to identify psoriasis patients with new onset arthritis or sub-clinical disease. Lastly, up to a third of psoriasis patients with moderate to severe skin disease report they are undertreated and many are on topical agents unlikely to have a significant effect on subclinical or clinically apparent joint inflammation.
Up to 150 subjects will be consented and studied in this cross-sectional study - 125 subjects with Psoriasis (Ps) and 25 Healthy controls. Power Doppler Ultrasound (PDUS) in joints and entheses will be analyzed to find at least 35 subjects with positive US findings defined as synovitis, effusion, joint erosions, or increased vascularity otherwise known as a signal. Up to 50 Ps patients with positive PDUS results will be followed prospectively and contacted at intervals to update medication history indefinitely. Ps patients will be asked for a follow up PDUS 4 months post start of biologic, DMARD therapy or phototherapy if the patient decides to go on such therapies to study longitudinally.
Up to 30 bone marrow aspirations on healthy and PDUS positive Psoriasis subjects will be performed. A bone marrow aspiration post start of biologic or DMARD standard of care therapy will be assessed as well.
Research assays: serum will be used to measure biomarker 14-3-3η levels, which may be analyzed by an external company. Peripheral blood will be used to measure the frequency of DC-STAMP+ cells (CD14+DC-STAMP+ CD4+DCSTAMP+DC-STAMP+IL-17+). Using multichromatic flow cytometry, we will measure DC-STAMP expression on peripheral blood cells and on bone marrow cells. To determine if elevated BM DC-STAMP expression by stromal cells, T cells and/or monocytes promotes OC formation, co-cultures of bone marrow stromal and hematopoietic cells with peripheral blood cells will be analyzed for OCPs.
- Conditions
- Psoriasis
- Keywords
- Psoriasis, PDUS
- 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 | Individuals with psoriasis | |
| Healthy | Individuals that are healthy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of abnormal ultrasound signals with peripheral blood in subclinical PsA
To examine if subclinical PsA, as measured by abnormal ultrasound signals, correlate with peripheral blood cellular and serologic biomarkers of inflammation and joint damage. Power Doppler Ultrasound (PDUS) signals in joints and entheses of approximately 125 Ps pts in order to identify at least 35 pts with subclinical PsA (and 25 healthy controls). Investigators will compare both the frequency of DC-STAMP+ cells (CD14+DCSTAMP+ CD4+DC-STAMP+ DC-STAMP+IL-17+) and serum biomarker 14-3-3η levels between the Ps pts with subclinical PsA (PDUS+), up to 50 Ps pts without evidence of subclinical PsA (PDUS-), and controls.
Measured: Week 0
To understand if systemic therapies for Ps can reduce subclinical joint inflammation.
Investigators will monitor the change in PDUS signals and PB biomarkers in at least 35 subclinical PsA pts identified from baseline to month 4 following Phototherapy, DMARD or Biologic therapy.
Measured: Week 0 to week 16
To examine if DC-STAMP expression on BM cells is associated with subclinical PsA and increased OC formation in psoriasis.
Investigators will analyze PB and BM DC-STAMP expression in PDUS+ pts evaluated at baseline and at 4 months post standard of care treatment. Then, to determine if elevated BM DC-STAMP expression by stromal cells, T cells and/or monocytes promotes OC formation, co-cultures of BM stromal and hematopoietic cells with PB cells will be analyzed for OCPs.
Measured: Week 0 to week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study start19 Mar 2015
- Primary completionDec 2022
- Study completionDec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Rheumatology Research Foundation
- Responsible party
- Principal investigator, Christopher Ritchlin, University of Rochester
- Investigators
- Christopher Ritchlin, MD/MPH, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02413801
- Sponsor's protocol ID
- RSRB 53131
- Acronym
- RRF
- Status last verified
- Jun 2024
- First submitted
- 7 Apr 2015
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information of any type may be shared with researchers at other institutions. Subjects will be made aware of this in the informed consent form.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum, Cellular and Imaging Markers of Arthritis in Psoriasis Patients
- ClinicalTrials.gov ID
- NCT02413801
- Acronym / sponsor ID
- RRF / RSRB 53131
- Conditions
- Psoriasis
- Keywords
- Psoriasis, PDUS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Rheumatology Research Foundation
- Study start
- 19 Mar 2015 (actual)
- Primary completion
- Dec 2022 (actual)
- Study completion
- Dec 2023 (actual)
- First posted
- 10 Apr 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.
The events that underlie the conversion from Psoriasis to Psoriatic Arthritis (PsA) are not well understood. This conversion occurs 30% of the time within the first 10 years of psoriasis diagnosis. PsA patients have about a 50% chance of developing joint damage within the first 2 years of disease. A biomarker that identifies subclinical joint inflammation in psoriasis patients would allow for a diagnostic tool to allow for earlier intervention in psoriasis patients and provide a better understanding of the underlying molecular pathogenesis that may lead to development of new therapeutic targets in PsA.
Detailed description
Our long-term goals are to: 1) develop arthritis biomarkers in psoriasis patients that will facilitate early treatment interventions; and, 2) identify new therapeutic targets in PsA through better understanding of the underlying molecular pathogenesis. PsA, an inflammatory arthritis associated with psoriasis, affects approximately 650,000 adults in the United States and is associated with increased morbidity and mortality. Joint inflammation and damage arise within the first 2 years of disease in 50% of patients who manifest bone erosions and joint space narrowing on plain x-rays. The advent of Tumor Necrosis Factor antagonists (TNFi) for treatment of PsA has dramatically improved clinical response and slowed bone and cartilage degradation. Nevertheless, up to 45% of patients do not meet primary endpoints in clinical trials, which underscores the need for new therapeutic options.
Another approach to improve treatment response is early PsA diagnosis, and recent data indicate that treatment soon after disease onset can improve outcomes. Relevant to the potential for early intervention and prevention, psoriatic skin plaques typically precede PsA by 10 years. Moreover, a significant percentage of these psoriasis patients have subclinical musculoskeletal imaging findings. These findings provide an unparalleled opportunity for early intervention that could potentially limit or halt joint inflammation and damage. Regrettably, despite the obvious advantages of early diagnosis and treatment, this goal remains elusive because the clinical significance of imaging abnormalities in psoriasis remains unknown. Furthermore, investigators have limited understanding of the mechanisms that underlie the transition from psoriasis to PsA, and investigators lack the disease specific biomarkers necessary to identify psoriasis patients with new onset arthritis or sub-clinical disease. Lastly, up to a third of psoriasis patients with moderate to severe skin disease report they are undertreated and many are on topical agents unlikely to have a significant effect on subclinical or clinically apparent joint inflammation.
Up to 150 subjects will be consented and studied in this cross-sectional study - 125 subjects with Psoriasis (Ps) and 25 Healthy controls. Power Doppler Ultrasound (PDUS) in joints and entheses will be analyzed to find at least 35 subjects with positive US findings defined as synovitis, effusion, joint erosions, or increased vascularity otherwise known as a signal. Up to 50 Ps patients with positive PDUS results will be followed prospectively and contacted at intervals to update medication history indefinitely. Ps patients will be asked for a follow up PDUS 4 months post start of biologic, DMARD therapy or phototherapy if the patient decides to go on such therapies to study longitudinally.
Up to 30 bone marrow aspirations on healthy and PDUS positive Psoriasis subjects will be performed. A bone marrow aspiration post start of biologic or DMARD standard of care therapy will be assessed as well.
Research assays: serum will be used to measure biomarker 14-3-3η levels, which may be analyzed by an external company. Peripheral blood will be used to measure the frequency of DC-STAMP+ cells (CD14+DC-STAMP+ CD4+DCSTAMP+DC-STAMP+IL-17+). Using multichromatic flow cytometry, we will measure DC-STAMP expression on peripheral blood cells and on bone marrow cells. To determine if elevated BM DC-STAMP expression by stromal cells, T cells and/or monocytes promotes OC formation, co-cultures of bone marrow stromal and hematopoietic cells with peripheral blood cells will be analyzed for OCPs.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psoriasis | – | –Individuals with psoriasis |
| Healthy | – | –Individuals that are healthy |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female subjects that are 18 years old and older. Due to the demographic distribution of the disease we expect all or nearly all subjects to be Caucasian, however no subjects will be excluded from any group based on race or ethnic origin.
Key inclusion criteria (12 listed)
- All Subjects
- Psoriasis Subjects
- Bone Marrow Aspiration:
Key exclusion criteria (16 listed)
- All Subjects
- Healthy subjects:
- Psoriasis Subjects:
- Bone Marrow Aspiration:
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
Correlation of abnormal ultrasound signals with peripheral blood in subclinical PsA
Time frame: Week 0
To examine if subclinical PsA, as measured by abnormal ultrasound signals, correlate with peripheral blood cellular and serologic biomarkers of inflammation and joint damage. Power Doppler Ultrasound (PDUS) signals in joints and entheses of approximately 125 Ps pts in order to identify at least 35 pts with subclinical PsA (and 25 healthy controls). Investigators will compare both the frequency of DC-STAMP+ cells (CD14+DCSTAMP+ CD4+DC-STAMP+ DC-STAMP+IL-17+) and serum biomarker 14-3-3η levels between the Ps pts with subclinical PsA (PDUS+), up to 50 Ps pts without evidence of subclinical PsA (PDUS-), and controls.
To understand if systemic therapies for Ps can reduce subclinical joint inflammation.
Time frame: Week 0 to week 16
Investigators will monitor the change in PDUS signals and PB biomarkers in at least 35 subclinical PsA pts identified from baseline to month 4 following Phototherapy, DMARD or Biologic therapy.
To examine if DC-STAMP expression on BM cells is associated with subclinical PsA and increased OC formation in psoriasis.
Time frame: Week 0 to week 16
Investigators will analyze PB and BM DC-STAMP expression in PDUS+ pts evaluated at baseline and at 4 months post standard of care treatment. Then, to determine if elevated BM DC-STAMP expression by stromal cells, T cells and/or monocytes promotes OC formation, co-cultures of BM stromal and hematopoietic cells with PB cells will be analyzed for OCPs.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: Yes. Information of any type may be shared with researchers at other institutions. Subjects will be made aware of this in the informed consent form.
Related trials for Psoriasis
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Recruiting
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Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
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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. This study is not recruiting at the moment.
Christopher Ritchlin, MD/MPH principal investigator
University of Rochester
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 University of Rochester 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 12 inclusion and 16 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: finished, as of the sponsor's last update on 6 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation of abnormal ultrasound signals with peripheral blood in subclinical PsA (time frame: Week 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2025.