Psoriatic Arthritis Pathobiology and Its Relationship With Clinical Disease Activity

NCT06676176 | Completed

• 1 other identifier: 010368 BHT
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to examine the relationship between synovial histopathology and change in clinical disease activity over time in a population of patients with psoriatic arthritis who have failed to respond to first-line treatment. It is a prospective, open-labelled study

Conditions

Arthritis, Psoriatic

Outcome Measures

Primary Outcomes (1)

• DAS

  The primary outcome measure is the Disease Activity Score (DAS), a composite score calculated using the Ritchie articular index (range 0-78), swollen joint count (range 0-44), patient--scored global health assessment on a visual analogue scale (range 0-100) and lab--measured erythrocyte sedimentation rate (ESR). This is used to assess the relationship between the level of interleukin(IL)-23 within the psoriatic arthritis synovium and clinical disease activity over time.

  4 months

Secondary Outcomes (6)

• Relationship between IL-23 levels within the PsA synovium/ skin and clinical disease activity

  4 months

• Relationship between clinical disease activity and synovial, skin and/or blood levels of key immune signalling molecules involved in psoriatic disease

  4 months

• Relationship, if any, between clinical disease characteristics and genotype

  4 months

• Relationship between activated inflammatory cells in psoriatic skin and those in the psoriatic synovium

  4 months

• Relationship between clinical disease activity and synovitis, assessed using grey scale with power doppler US imaging

  4 months

Study Arms (1)

Observational

This study will be an observational study of a cohort of psoriatic arthritis patients who have failed to achieve sufficient response to standard non-biologic therapy. As they start their next treatment, this study aims to investigate the evolution of these patients in terms of the clinical, molecular and cellular profiles within the joint lining, peripheral blood and skin.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a prospective observational study of PsA patients who have persistent disease activity despite an adequate trial of standard non-biologic disease-modifying therapy, and who may proceed to receive their first or second biologic drug as the next treatment strategy.

You may qualify if:

• Men and women between 18 and 75 years of age inclusive;
• Patients with Psoriatic Arthritis as defined by the CASPAR criteria;
• Patients who have persistent active disease (defined as having 3 or more swollen and 3 or more tender joints) despite an adequate trial of 2 or more standard non-biologic disease-modifying drugs, administered either individually or in combination;
• Subjects who are naïve to biologic therapy or who have experienced but failed one previous class of biologic agent;
• The patient must be able to comply with the study visit schedule, treatment plans, lab tests and other study procedures;
• The patient must be capable of giving informed consent.

You may not qualify if:

• Women who are pregnant or breastfeeding;
• Men and women of childbearing potential who decline to employ adequate birth control measures (e.g. abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) for the duration of the study;
• Active TB, or evidence of latent TB without adequate therapy for TB, initiated prior to first dose of biologic. Also excluded are patients with evidence of an old or latent TB infection without documented adequate therapy. Patients with previous or current close contact with an individual with active TB, or history of active TB, and patients who have completed treatment for active TB should have had a thorough evaluation for TB prior to study enrolment as recommended by a local infectious disease specialist or published local guidelines of TB control agencies;
• History of septic arthritis within a native joint within the last 12 months;
• Presence of a transplanted organ (with the exception of a corneal transplant occurring more than 3 months prior to screening);
• Malignancy within the past 5 years (except for squamous or basal cell carcinoma of the skin that has been treated, with no evidence of recurrence);
• History of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, infra-clavicular, epitrochlear, or periaortic areas), or splenomegaly;
• Known recent substance abuse (drug or alcohol);
• History of or current primary inflammatory joint disease or primary rheumatological autoimmune disease other than PsA;
• Poor tolerability of venepuncture required for blood sampling during the study period;
• Patients unable to tolerate synovial biopsy or in whom this is contraindicated (e.g. on anti-coagulants may not be suitable). However, assessment of suitability for the biopsy procedure will be a local decision.

Sponsors & Collaborators

• Barts & The London NHS Trust: lead

Study Sites (1)

Barts Health NHS Trust

London, E1 4DG, United Kingdom

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 Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: November 6, 2024
• Study Start: June 1, 2015
• Primary Completion: June 24, 2020
• Study Completion: June 24, 2020
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)