NCT01176682已完成不适用
European Real Life Study on NSAIDs Treated Patients With Osteoarthritis (OA), Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS): Assessment of Pain Relieve, Gastrointestinal (GI) Symptoms, Adherence and Health Resource Consumption
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,149
- 试验地点
- 1
- 主要终点
- The incidence of selected GI events, classified as "symptomatic" or "complicated" GI events. Reported by the patients at the follow-up visits.
研究概览
简要总结
The aim of this study is to find out how patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis receiving NSAID-therapy are treated and managed by their doctor in usual clinical practice, how patients comply with their treatment and how satisfied they are with their treatment.
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
- •Diagnosis of arthritic disorder (osteoarthritis, rheumatoid arthritis or ankylosing spondylitis)
- •Already receiving NSAID treatment at enrolment visit
排除标准
- •Inability to complete the study related questionnaires
- •Current participation in any interventional study
结局指标
主要结局
The incidence of selected GI events, classified as "symptomatic" or "complicated" GI events. Reported by the patients at the follow-up visits.
时间窗: Time from NSAID treatment prescription to first diagnosis of the GI event for each patient will be registered. Each patient will be followed up for 6 months.
次要结局
- Number of health care visits and days of hospitalisation (health care consumption) related to arthritic disorder and/or GI events as reported by the patients at the follow-up visits.(Health care consumption accumulated over the 6 months study period will be registered.)
- Quality of life assessed by EuroQol-5 Dimension (EQ-5D) at baseline and the follow-up visits. Measure how selected GI events impact the EQ-5D score.(Measurements at baseline, 3 months and 6 months)
- Adherence with NSAIDs and proton pump inhibitors (PPI) measured by Morisky-Green-Levine Medication Assessment Scale (MMAS) at baseline and follow-up visits.(Measurements at baseline, 3 months and 6 months)
研究者
研究点 (1)
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