Serum, Cellular and Imaging Markers of Arthritis in Psoriasis Patients

NCT02413801 | Completed

• 1 other identifier: RSRB 53131
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Psoriasis

Keywords

Psoriasis; PDUS

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Week 0 to week 16

Study Arms (2)

Psoriasis

Individuals with psoriasis

Healthy

Individuals that are healthy

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Rochester: lead
• Rheumatology Research Foundation: collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood and bone marrow samples that remain after study assays are completed may be stored for future non-genetic research.

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Christopher Ritchlin, MD/MPH

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., M.P.H.; Professor of Medicine, Chief of Allergy, Immunology & Rheumatology Division

Study Record Dates

• First Submitted: April 7, 2015
• First Posted: April 10, 2015
• Study Start: March 19, 2015
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: March 6, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: Once a subject signs the consent form to allow for sharing, any sample collected may be shared with collaborating institutions. This will last indefinitely or until the subject cancels consent to share.
• Access Criteria: Only investigators that the study team collaborates with will have access to samples. Data will not include any information that is identifying.

Locations

US (1)