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临床试验/NCT03330769
NCT03330769Unknown不适用

Ultrasound in PSoriatic Arthritis TREAtMent - UPSTREAM

University of Cagliari4 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2017年2月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
250
试验地点
4
主要终点
Minimal disease activity

研究概览

简要总结

BACKGROUND Psoriatic arthritis (PsA) is a systemic inflammatory disease with articular and extra-articular features. Establishing the prognosis of a patient with PsA is hence important to define the treatment strategy. Currently, observational and prospective cohort studies have identified prognostic factors correlating with the achievement of therapeutic response. Nevertheless, despite the importance of identifying prognostic factors in a disease with a functional disability comparable to rheumatoid arthritis, the studies are still limited.

PRIMARY OBJECTIVE In PsA with clinically active joint disease starting a new course of therapy, to evaluate the additional value of UltraSound(US)-score over clinical examination in detecting patients achieving MDA at 6 months.

STUDY DESIGN The study follows a multi-centre observational prospective cohort study design.

PATIENTS AND METHODS INCLUSION CRITERIA

  • Adult > 18 years of age with PsA (PsA according to the ClASsification criteria for Psoriatic Arthritis (CASPAR) - with joint involvement)
  • At least one joint clinically involved (both swelling and tenderness);
  • prescription of new course of d NSAIDs (monotherapy), steroid intra-articular injections (monotherapy), conventional Disease-Modifying AntiRheumatic Drugs (DMARDs), biologic DMARDs, including switches or dose augmentations indicated by the treating rheumatologist according to usual clinical practice before US acquisition;
  • Stable treatment before treatment modification (6 weeks);
  • Signed informed consent form.

CLINICAL ASSESSMENT Patient's clinical assessment will be performed according to the core set of domains for PsA proposed by the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and Outcome Measures in Rheumatology (OMERACT).

ULTRASOUND ASSESSMENT Sonographic evaluations will be performed by expert ultrasonographers in 44 joints, 36 tendons, 12 entheses and 2 bursae according to the score developed for psoriatic arthritis by the study group ultrasound of the Italian Society of Rheumatology (US-score PsA-SIR)

EXPECTED RESULTS AND SIGNIFICANCE The aim of this study is to identify clinical and US predictors of achieving MDA in PsA patients with active peripheral arthritis starting a new course of therapy.

详细描述

BACKGROUND Psoriatic arthritis (PsA) is a systemic inflammatory disease with articular and extra-articular features. To date remission is considered to be the ultimate goal of therapy in PsA, however, due to the characteristics of the disease with involvement of different domains, remission may be difficult to achieve and maintain and so a minimal disease activity (MDA) could be an acceptable goal. In view of the therapeutic target of remission or MDA, the identification of adverse prognostic factors and the best treatment strategy are two of the most important items in research agenda of PsA. Establishing the prognosis of a patient with PsA is hence important to define the treatment strategy. Currently, observational and prospective cohort studies have identified prognostic factors correlating with the achievement of therapeutic response. Nevertheless, despite the importance of identifying prognostic factors in a disease with a functional disability comparable to rheumatoid arthritis (RA), the studies are still limited. Undoubtedly, the concept of treat-to-target (T2T) in PsA needs further studies, especially with longer follow up and larger samples. In T2T strategies, it is necessary to quantify the disease activity and this is possible by composite indices. The heterogeneity of PsA including axial and peripheral involvement and specific features (i.e. dactylitis, enthesitis) as well as extra-articular features makes the use of a single composite index (e.g. Disease Activity for Psoriatic Arthritis-DAPSA, Composite Psoriatic Disease Activity Index-CPDAI) a challenge not resolved yet. An interesting possibility is to integrate musculoskeletal ultrasonography (US) with clinical examination to stratify patients and to decide treatments in a T2T strategy. In the last years the role of imaging is grown up and EULAR recommendations on the use of imaging techniques in chronic arthritis recognize the high sensitivity of US to detect disease activity better than clinical examination alone although the utility of US in clinical practice is not supported by sufficient evidence yet

AIM

The aim of this study is to identify clinical and US predictors of achieving MDA in PsA patients with active peripheral arthritis starting a new course of therapy.

Identifying prognostic factors of achieving remission or low disease activity will allow a better selection of patients with poorer outcome and a following improvement of the therapeutic strategies. Furthermore the possibility that US could be an added prognostic value makes this study a clear example of integration between the clinic and US. This study will respond to the need of tailoring treatment that would allow clinicians to practice a more effective and personalized medicine, optimizing the outcomes of patients with PsA as well as the treatments management.

STUDY OBJECTIVES

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult > 18 years of age with PsA (according to the CASPAR classification Criteria)
  • Clinically active arthritis, with at least one joint clinically involved (both swelling and tenderness) in patient not achieving the MDA;
  • Subject newly prescribed NSAIDs (monotherapy), steroid intra-articular injections (monotherapy), conventional DMARD, biologic DMARDs as indicated by the treating rheumatologist according to usual clinical practice before US acquisition;
  • Stable treatment before treatment modification (6 weeks);
  • Signed informed consent form;

排除标准

  • Minimal disease activity a the time of enrolment

研究组 & 干预措施

Patients with active Psoriatic Arthritis

Patients with clinically diagnosed PsA with clinically active joint disease starting a new course of treatment.

干预措施: New course of treatment (Drug)

结局指标

主要结局

Minimal disease activity

时间窗: 6 months

The Minimal disease activity (MDA) calculation will be based on the evaluation of 7 variables: 1. 68 tender joints count (≤1) 2. 66 swollen joint count (≤1) 3. Body Surface Area (BSA) ≤3 4. Patient pain VAS (≤15 mm); 5. Patient global disease activity VAS (≤20 mm); 6. HAQ (≤0.5); 7. Leeds Enthesitis Index (LEI) tender entheseal points (≤1) Patients will be classified as having MDA if they meet 5 out of these 7 criteria (value in brackets).

次要结局

  • Minimal disease activity(12 months)
  • Disease Activity for Psoriatic Arthritis (DAPSA)(6 and 12 months)
  • American College of Rheumatology (ACR) response score(6 and 12 months)
  • X-ray structural progression (mSVH score)(12 and 24 months)
  • Ultraosund structural progression(12 and 24 months)
  • Functional worsening(12 and 24 months)
  • Health Related Quality of life(12 and 24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matteo Piga

Researcher

University of Cagliari

研究点 (4)

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