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

NCT05925842 | Unknown

• 1 other identifier: MAXPSA001
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

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

Conditions

Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

• Target biomarker identification

  Identify candidate biomarkers able to discriminate between PsA with and without axial involvement

  18 months

Study Arms (2)

Participants with PsA without Axial Involvement

Participants with PsA with Axial Involvement

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult persons with diagnosed active PsA including psoriatic lesions, naive to biologic or tsDMARD therapies

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Group for Research and Assessment of Psoriasis and Psoriatic Arthritis: lead

Study Sites (2)

University of California San Diego

La Jolla, California, 92093, United States

Location

Seattle Rheumatology Associates

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Philip Mease, MD

  Group for Research and Assessment of Psoriasis and Psoriatic Arthritis

  PRINCIPAL INVESTIGATOR

• Vinod Chandran, MD

  Group for Research and Assessment of Psoriasis and Psoriatic Arthritis

  STUDY DIRECTOR

• Oliver Fitzgerald, MD

  Group for Research and Assessment of Psoriasis and Psoriatic Arthritis

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: June 29, 2023
• Study Start: January 25, 2023
• Primary Completion: February 1, 2024
• Study Completion: September 1, 2024
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)