An Observational Study To Evaluate The Clinical Remission In Early Aggressive Rheumatoid Arthritis (Artrite Reumatoide Precoce Aggressiva Italian Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Prevalence of clinical remission, according to the DAS 28 definition of clinical remission, in patients with early aggressive RA receiving different therapies at 1 year.
研究概览
简要总结
This is an observational prospective, multicenter study. The aim of the study is to evaluate how the Italian population of patients are treated with early aggressive RA, defined by the Italian Society of Rheumatology Guidelines, (GIARA Registry Study Group. Clin Exp Rheumatol 2003;21(Suppl. 31):S129-S132), in rheumatologic clinical practice and whether recent scientific evidence or new treatments available to rheumatologists can change their practice in a 2 year follow-up. The observation will primarily focus on the disease activity and clinical remission in patients who are receiving different treatment strategies. The primary goal is to define prevalence of clinical remission, according to the (Disease Activity Score) DAS 28 definition of clinical remission, in patients with early aggressive RA receiving different therapies at 1 year.
Secondary objective are assessment of:
- Prevalence of Remission at the second year
- Disease activity at the first and second year.
- ACR 20%, 50%, 70% response at the first and second year.
- Quality of Life in patients with or without remission at the first and second year
- Safety Evaluations
详细描述
It was expected that approximate 200 patients were enrolled in the study. Have been enrolled 152 patients. A Statistical Analysis Plan will contain a detailed description of criteria for valuable patients for analyses and a description of statistical analyses. In general, all patients who respond inclusion/exclusion criteria at baseline will be considered valuable for the study. The summaries will include descriptive statistics (mean, standard deviation, sample size) for the continuous parameters, and absolute frequencies and percentages for the remaining categorical parameters.
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
- 否
入选标准
- •Inclusion Criteria Based On Clinical Practice of Aggressive RA
- •Diagnosis of early aggressive RA in accordance with local guideline
- •Disease duration < 2 years and at least six months since onset of symptoms
- •Patients naïve to anti-TNFa drugs and DMARDs, including MTX, or assuming one or more DMARD without complete response
排除标准
- •Exclusion Criteria Based on Clinical Practice of Aggressive RA
- •Patients should not be included in the study if they have participated in any interventional clinical trial within the previous 2 years.
结局指标
主要结局
Prevalence of clinical remission, according to the DAS 28 definition of clinical remission, in patients with early aggressive RA receiving different therapies at 1 year.
时间窗: 12-24 months
次要结局
- -Prevalence of Remission at the second year.(12-24 months)
- Disease activity at the 1st and 2nd year(12-24 months)
- ACR 20%, 50%, 70% response at the 1st and 2nd year(12-24 months)
- QoL in patients with or without remission at the first and second year(12-24 months)
- Safety Evaluations(12-24 months)