Psoriatic Arthritis Pathobiology and Its Relationship With Clinical Disease Activity

Barts & The London NHS Trust1 site in 1 country29 target enrollmentJune 2015

ConditionsArthritis, Psoriatic

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Arthritis, Psoriatic
Sponsor: Barts & The London NHS Trust
Enrollment: 29
Locations: 1
Primary Endpoint: DAS
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

June 2015

End Date

June 24, 2020

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Barts & The London NHS Trust

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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;
•As per care within a standard NHS setting, active infections of a serious nature such as HIV, HBV, pneumonia, or pyelonephritis are to be excluded. A history of previous serious infection is to be assessed individually for risk of re-activation, and a decision to treat (and with which agent) would be made according to the treating physician's discretion, as would normally occur within standard care. Less serious infections (such as upper respiratory tract infection \[colds\] or simple urinary tract infection) need not be considered exclusions at the discretion of the investigator;
•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;

Outcomes

Primary Outcomes

DAS

Time Frame: 4 months

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.

Secondary Outcomes

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)
Relationship between clinical enthesitis scores (eg. LEI) and US scores of enthesitis(4 months)