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临床试验/NCT02924623
NCT02924623已完成不适用

Discordance Dans l'évaluation d'Activité de la Polyarthrite Rhumatoide

Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
Patient's global assessment

研究概览

简要总结

Patients and physicians often differ in their perceptions of rheumatoid arthritis (RA) disease activity, as quantified by the patient's global assessment (PGA) and by the evaluator's global assessment (EGA).

The objectives of this study were:

  1. to explore the extent and reasons for the discordance between patients and physicians in their perception of RA disease activity
  2. to determine if this discordance at baseline is associated with RA outcomes at 1 year (remission, function and structure) in early arthritis (EA) in daily clinical practice.
  • Patients: from the French cohort of early arthritis (EA) ESPOIR³ (at least 2 swollen joints for less than 6 months, DMARD naïve), fulfilling the ACR-EULAR criteria for RA at baseline

Analysis: At baseline, agreement between PGA and EGA (Bland-Altman plot) was assessed. Multivariate linear regression was used to determine the patient and EA features independently associated with discordance (calculated as PGA - EGA). Logistic regression was used to analyze discordance as│PGA - EGA│≥20.

Multivariate logistic models were used to determine if discordance at baseline is associated with remissions (Boolean, SDAI and DAS28), functional stability (HAQ≤0.5 and deltaHAQ≤0.25) and absence of radiographic progression (delta Sharp score<1) after 1 year of follow-up.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •fulfilling the ACR-EULAR criteria for RA

排除标准

  • 未提供

结局指标

主要结局

Patient's global assessment

时间窗: day 0

The discordance between the patient's and the evaluator's global assessment will be calculated.

Evaluator's global assessment

时间窗: day 0

The discordance between the patient's and the evaluator's global assessment will be calculated.

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier Universitaire de Nīmes
申办方类型
Other
责任方
Sponsor

研究点 (1)

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