Clinical trial NCT05925842: Clinical and Molecular Characterization of Axial Psoriatic Arthritis (PsA), A Pilot Study
Official title: Clinical and Molecular Characterization of Axial Psoriatic Arthritis (PsA), A Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Psoriatic Arthritis
Lead sponsor: Group for Research and Assessment of Psoriasis and Psoriatic Arthritis
Sponsor class: NETWORK
First posted: 2023-06-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult persons with diagnosed active PsA including psoriatic lesions, naive to biologic or tsDMARD therapies

Brief summary: 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


Eligibility 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).

Primary outcomes:
measure: Target biomarker identification
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Seattle
country: United States
facility: Seattle Rheumatology Associates
state: Washington
Study officials:
affiliation: Group for Research and Assessment of Psoriasis and Psoriatic Arthritis
name: Philip Mease, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Group for Research and Assessment of Psoriasis and Psoriatic Arthritis
name: Vinod Chandran, MD
role: STUDY_DIRECTOR
affiliation: Group for Research and Assessment of Psoriasis and Psoriatic Arthritis
name: Oliver Fitzgerald, MD
role: STUDY_DIRECTOR
References: