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Clinical and Molecular Characterization of Axial Psoriatic Arthritis (PsA), A Pilot Study

Study Purpose

Objectives: To identify a candidate set of biomarkers specific to AxPsA. Overview: Clinical and imaging characterization of PsA patients will be combined with extensive molecular assessment of both liquid and tissue compartments to identify biomarkers which differentiate PsA patients with and without axial involvement

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Persons with PsA diagnosed by a consultant Rheumatologist with disease duration of > 3 months but < 10 years with or without IBP.
  • - Adults between the ages 18 and 80 years, with joint disease onset after 16 years of age.
  • - Patients able to understand and complete consent procedures.
  • - Study participants must have PsA, meet CASPAR criteria, and must have active disease as defined by the treating rheumatologist, including an evaluable psoriatic skin lesion amenable to 6mm punch skin biopsy.
o Psoriasis should be diagnosed by a consultant rheumatologist or dermatologist.
  • - Study participants must have been on consistent therapy for their PsA for the past 90 days.
  • - Study participants must be naïve to biological treatment and targeted synthetic DMARD treatment (examples: JAK inhibitors, apremilast)

    Exclusion Criteria:

    - • Persons with musculoskeletal (peripheral or axial) symptoms for >10 years.
  • - Persons with planned major surgery (e.g., joint replacement) within the duration of the collection of data for the study.
  • - Persons with a history of chemotherapy, radiation therapy or immunotherapy for cancer in the preceding 5 years.
  • - Persons with ongoing cancer (not excluding non-melanoma skin, cervical/breast in-situ carcinoma) but those fully recovered from an episode of cancer (in remission for more than 5 years) may be included at the discretion of the patient's treating rheumatologist.
  • - Persons with an active severe or serious infection.
  • - Patients with non-severe infection at the discretion of the Investigator.
  • - Persons with other concomitant disorders incompatible with study (at discretion of Investigator).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05925842
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Group for Research and Assessment of Psoriasis and Psoriatic Arthritis
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Philip Mease, MDVinod Chandran, MDOliver Fitzgerald, MD
Principal Investigator Affiliation Group for Research and Assessment of Psoriasis and Psoriatic ArthritisGroup for Research and Assessment of Psoriasis and Psoriatic ArthritisGroup for Research and Assessment of Psoriasis and Psoriatic Arthritis
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Psoriatic Arthritis
Arms & Interventions

Arms

: Participants with PsA without Axial Involvement

: Participants with PsA with Axial Involvement

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California San Diego, La Jolla, California

Status

Address

University of California San Diego

La Jolla, California, 92093

Seattle Rheumatology Associates, Seattle, Washington

Status

Address

Seattle Rheumatology Associates

Seattle, Washington, 98122

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