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临床试验/NCT03620188
NCT03620188已完成不适用

Are we Meeting Patient Treatment Goals With Guideline-based Therapy for Psoriatic Arthritis

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2018年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
250
试验地点
1
主要终点
Predictors of reaching PsA treatment goals/treatment success from a patient perspective.

研究概览

简要总结

The PaGoPsA study objective is to ascertain if guideline-based psoriatic arthritis clinical care achieves individual patient goals as articulated by patients, and to identify predictors of achieving individual patient goals from psoriatic arthritis treatment.

详细描述

Psoriatic arthritis (PsA) is a heterogeneous autoimmune disease that occurs in one in three people with the skin disease psoriasis. PsA can cause arthritis (joint inflammation), enthesitis (tendon and ligament inflammation), sausage digits (swollen entire finger or toe), spondyloarthritis (spinal inflammation). Skin involvement by psoriasis is also highly variable in terms of psoriasis type and location. Through combined skin and musculoskeletal involvement, psoriatic disease has a significant life impact with decrease quality of life including uncomfortable symptoms, ability to participate in life and functioning. Medications used to treat PsA have sometimes an uneven effect on the various PsA manifestations where some are more effective for skin while others more effective for the joints. In this context, clinical care and treatment of PsA is a complex process which balances disease activity with medication risks and benefits as well as patient priorities. Professional PsA treatments guidelines state that PsA treatment goals are disease remission or low disease activity. Several studies to date have shown that physicians tend to overestimate remission and low disease activity in PsA patients when compared to disease activity indices. Also patients and physicians frequently do not align on perceptions of remission or low disease activity. In the proposed study the investigators aim to identify predictors of successful treatment from a patient perspective on a range of disease measures including psoriasis, arthritis, enthesitis, dactylitis, patient reported outcomes, and laboratory assessments which are routinely collected in the clinical care of PsA. Secondary endpoints are to quantify longitudinally how stable a state of treatment success is from a patient perspective, and to define score ranges for disease measurements, including health-related quality of life measures, that correspond to treatment success from a patient perspective. The impact of this research is that the investigators will be able to define parameters predictive of achieving treatment success from a patient perspective, which will then inform goals of care for psoriatic arthritis.

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 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • English speaking/reading adults
  • Patients of the Johns Hopkins Arthritis Center and/or the Johns Hopkins Psoriatic Arthritis Clinical Program
  • Followed every 3-4 months for regular psoriatic arthritis clinical care
  • Meet Classification Criteria for Psoriatic Arthritis (CASPAR)
  • Able to interact with touch screen computer.

排除标准

  • 未提供

结局指标

主要结局

Predictors of reaching PsA treatment goals/treatment success from a patient perspective.

时间窗: 12-16 weeks

The primary outcome determination is based on the patients' report of whether they are/are not at goal with their PsA treatment.

次要结局

  • To define a status of PsA treatment where patient treatment goals have been met.(52 weeks)
  • Prevalence of treatment success in guideline -based treatment in psoriatic arthritis from the patients' perspective(52 weeks)
  • Worsening thresholds (treatment failure) if transition is from goals met to not met.(12-16 weeks)
  • Stability of a state of treatment goals met at subsequent study visits.(52 weeks)
  • Improvement thresholds (treatment success) that correspond to a patient transition from goals not met to met.(12-16 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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