NCT06676176已完成不适用
Psoriatic Arthritis Pathobiology and Its Relationship With Clinical Disease Activity
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- DAS
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
- •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.
结局指标
主要结局
DAS
时间窗: 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.
次要结局
- 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)
研究者
研究点 (1)
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