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NCT02413801Completed

Serum, Cellular and Imaging Markers of Arthritis in Psoriasis Patients

Source: ClinicalTrials.gov · Last updated 6 Mar 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
103 (actual)
First submitted
7 Apr 2015
Start date
19 Mar 2015
Primary completion date
31 Dec 2022
Lead sponsor
University of Rochester
Diseases
Psoriasis
NCT number
NCT02413801

What you commit to

  • Study type: Observational
  • Participants enrolled: 103
  • From 19 Mar 2015 to the primary completion date, 31 Dec 2022
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Lab values

  • 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.

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 89 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Rochester
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.