Prevalence Study of Gastrointestinal Risk Factors in Patients With Osteoarthritis, Rheumatoid Arthritis and Ankylosing Spondylitis Receiving Treatment With Non- Steroidal Anti- Inflammatory Drugs.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 5,383
- 试验地点
- 1
- 主要终点
- Number of subject with age above 60 years.
研究概览
简要总结
RATIONAL is a multinational, multicentre, observational, cross sectional study of adult patients in treatment with NSAID therapy for OA, RA or AS during for at least 2 weeks before study visit (at least one dose).
详细描述
Prevalence study of gastrointestinal risk factors in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis receiving treatment with non- steroidal anti- inflammatory drugs.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of subject informed consent.
- •Female and/or male, aged > 21 years.
- •Patients diagnosis with RA (ACR 1987 or ACR/EULAR 2010 criteria), OA (ACR 1986, 1990 and 1991 criteria) or AS (New York 1984 criteria or ESSG 2002 criteria) (documented in the medical record).
- •Patients receiving at least one dose of NSAIDs.
排除标准
- •Participation in any interventional study involving investigational drugs.
- •Patient refuses to fill in the study questionnaires.
- •Pregnant or breastfeeding women.
- •Patients with active neoplastic disease in the last 5 years, except basal-cell carcinoma.
结局指标
主要结局
Number of subject with age above 60 years.
时间窗: Up to 4 weeks.
Number of patients treated concomitantly with acetylsalicylic acid, oral corticosteroids or anticoagulants or NSAIDs.
时间窗: Up to 4 weeks.
Number of patients with previous ulcer history.
时间窗: Up to 4 weeks.
Number of patients with previous ulcer bleeding history.
时间窗: Up to 4 weeks.
Number of patients with history of dyspepsia.
时间窗: Up to 4 weeks.
次要结局
- Descriptive profile of patients demographics: gender, ethnicity, age, educational level, professional status.(Up to 4 weeks.)
- Descriptive profile of medical history: nicotine use, relevant medical conditions, history peptic ulcer, chronic drug therapy related to relevant medical conditions.(Up to 4 weeks.)
- Descriptive profile of medical treatment with NSAIDs, ASA, PPI, DMARDs, SSRI.(Up to 4 weeks.)
- Descriptive profile of disease: type of rheumatic disorder: OA, RA or AS and date of first diagnosis.(Up to 4 weeks.)
- Descriptive profile of Health Care Resources consumption: number of hospitalizations due to the rheumatic disorder and/or GI complications.(Up to 4 weeks.)
- Gastrointestinal Symptoms Rating Scale (GSRS).(Up to 4 weeks.)
- Treatment Satisfaction for medication for OA patients (TSQM).(Up to 4 weeks.)
- Treatment adherence (Morisky Medication Assessment Scale- MMAs-4).(Up to 4 weeks.)
- Patient Quality of Life (EQ-5D).(Up to 4 weeks.)
- Osteoarthritis Index capturing elements of pain and physical disability (WOMAC VA3.1).(Up to 4 weeks.)
- Health Assessment Questionnaire (HAQ).(Up to 4 weeks.)