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

Psoriatic Arthritis Clinical Trial

— MONOLITH  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05925842
• Other study ID #: MAXPSA001
• Status: Enrolling by invitation
• Start date: January 25, 2023
• Est. completion date: September 2024

Study information

• Verified date: June 2023
• Source: Group for Research and Assessment of Psoriasis and Psoriatic Arthritis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: September 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Locations

Country	Name	City	State
United States	University of California San Diego	La Jolla	California
United States	Seattle Rheumatology Associates	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Group for Research and Assessment of Psoriasis and Psoriatic Arthritis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target biomarker identification	Identify candidate biomarkers able to discriminate between PsA with and without axial involvement	18 months