Mechanism of Action Study of Ustekinumab Treatment in Psoriatic Arthritis: Impact on Cellular and Molecular Pathways of Synovial Inflammation and Tissue Remodeling
试验速览
- 阶段
- 不适用
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Biological effect of treatment on synovium obtained via arthroscopy from a swollen knee or ankle.
研究概览
简要总结
The purpose of this study is to determine the mechanism of action on target tissue level of ustekinumab treatment in psoriatic arthritis patients.
Patients who are planning to start treatment with anti-p40 therapy (ustekinumab) will be included in the trial.
At week 0, 12 and 24 peripheral blood, synovial tissue and skin will be obtained and analysed with different techniques to assess the effect of the therapy on inflammatory pathways.
详细描述
Rationale:
The overall aim of the study is to determine which downstream cellular and molecular pathways involved in psoriatic arthritis (PsA) pathogenesis are modulated by Interleukine 23/Interleukine12 P40 subunit (IL23/12 P40) blockade. As we have ample evidence that relevant disease-specific pathways are found in the primary target tissues, in particular in synovial tissue obtained from peripheral joints, but not in peripheral blood, we will strongly focus on this compartment by obtaining paired biopsies before and after treatment.
Objectives:
The primary objective is to assess the effect of IL23/12 P40 blockade on cellular en molecular pathways involved in PsA disease in the synovium, in the synovial fluid and peripheral blood.
The secondary objective is to compare which cellular/molecular disease pathways are affected by IL23/12 P40 blockade and not by tumour necrosis factor (TNF) blockade and thereby identify molecular biomarkers which may help to determine which patients may benefit from this treatment in comparison with anti-TNF treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients age > 18 years diagnosed with Psoriatic Arthritis according to the CASPAR criteria
- •Patient for whom the treating physician has decided to prescribe in the usual manner: Ustekinumab (Stelara) (45mg/ injection, given on week 0, 4, and every 12 weeks thereafter)
- •Active disease defined by ≥1 swollen and ≥ 1 tender joint, and at least 1 swollen knee or ankle joint at baseline
排除标准
- •Contraindications for needle-arthroscopy such as joint replacement (in the affected knee or ankle joint).
- •Use of any investigational drug and/or devices within 4 weeks of baseline, or a period of 5 half-lives of the investigational drug, whichever is longer.
结局指标
主要结局
Biological effect of treatment on synovium obtained via arthroscopy from a swollen knee or ankle.
时间窗: Cellular and molecular changes of the synovium of samples obtained at week 0 compared with week 12 and week 24.
Cellular and molecular changes of the synovium.
次要结局
未报告次要终点
研究者
D.L.P. Baeten
Prof. Dr. D.L.P. Baeten
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)