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临床试验/NCT02641977
NCT02641977已完成不适用

Longterm Followup of Patients With Rheumatoid Arthritis Treated With Methotrexate Enroled in the Ratingener Rheuma-Kohorte

Ruhr University of Bochum1 个研究点 分布在 1 个国家目标入组 271 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
271
试验地点
1
主要终点
mortality

研究概览

简要总结

Longterm followup of patients with rheumatoid arthritis 30 years after starting a baseline treatment with Methotrexate.

详细描述

Objective. 30-year follow-up of rheumatoid arthritis (RA) patients treated with methotrexate (MTX) in the 1980s to analyze the association of the degree of response to MTX with long-term mortality.

Methods. In this observational cohort study, 271 RA patients who had started treatment with MTX between 1980 and 1987 were included (mean age 58 years, mean disease duration 8.5 years). One year after baseline, the treatment response to MTX was evaluated. Responders were defined as patients with at least 20% improvement. Thereafter, assessments were performed at 10 and 18 years after baseline. This re-evaluation was done to provide the data after 30 years of follow-up. Standardized mortality ratios (SMR) are calculated, Cox regression and logistic regression are performed.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • rheumatoid arthritis
  • treatment with methotrexate
  • active disease

排除标准

  • low disease activity
  • previous treatment with methotrexate

结局指标

主要结局

mortality

时间窗: 30 years

次要结局

未报告次要终点

研究者

发起方
Ruhr University of Bochum
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dietmar Krause, MD

Principal investigator

Ruhr University of Bochum

研究点 (1)

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