CONIFER (Characterization of NSAID Intake for Established Rheumatoid Arthritis)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 27
- 主要终点
- Amount of NSAIDs Used During 14 Days After 6-8 Weeks of Tocilizumab Administration
研究概览
简要总结
This nationwide, multicenter, single arm, prospective, non-interventional study will evaluate the quantitative pattern of NSAID use and the impact of treatment with tocilizumab on NSAID use in a representative cohort of participant with moderate to severe active RA who have either responded inadequately to, or who were intolerant to previous therapy with one or more synthetic disease modifying anti-rheumatic drug (sDMARD), and for whom the physician has made the individual decision to initiate tocilizumab (subcutaneous [SC] or intravenous [IV]) as first biological disease modifying anti-rheumatic drug (DMARD) therapy according to the summary of product characteristics (SPC).
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
- •Participants with moderate to severe active RA who have either responded inadequately to, or who were intolerant to, previous therapy with one or more sDMARDs and for whom the physician has made the individual decision to be treated with tocilizumab (SC or IV)
- •Current users of NSAIDs due to RA as assessed by the physician
排除标准
- •Contraindications to treatment with tocilizumab as per SPC
- •Prior therapy with tocilizumab
研究组 & 干预措施
Participants With RA
Participants with RA who are being treated with tocilizumab and NSAIDs will be observed for approximately 6 months to evaluate the quantitative pattern of NSAID use and the impact of treatment with tocilizumab on NSAID use.
干预措施: Tocilizumab (Drug)
Participants With RA
Participants with RA who are being treated with tocilizumab and NSAIDs will be observed for approximately 6 months to evaluate the quantitative pattern of NSAID use and the impact of treatment with tocilizumab on NSAID use.
干预措施: NSAIDs (Drug)
结局指标
主要结局
Amount of NSAIDs Used During 14 Days After 6-8 Weeks of Tocilizumab Administration
时间窗: 14 days after 6-8 weeks of tocilizumab administration
Amount of NSAIDs Used During 14 Days Prior to First Tocilizumab Administration
时间窗: Day -14 to Day 0 (Baseline)
Amount of NSAIDs Used During 14 Days After 12-16 Weeks of Tocilizumab Administration
时间窗: 14 days after 12-16 weeks of tocilizumab administration
Percentage of Participants by NSAIDs Dose Categories (Low-Dose and High-Dose) During 14 Days Prior to First Tocilizumab Administration
时间窗: Day -14 to Day 0 (Baseline)
NSAIDs high-dose refers to mean defined daily dose (DDD) greater than (\>) 100 percent (%) and low-dose refers to mean DDD lesser than or equal to (\</=) 100%.
Percentage of Participants by NSAIDs Dose Categories (Low-Dose and High-Dose) During 14 Days After 6-8 Weeks of Tocilizumab Administration
时间窗: 14 days after 6-8 weeks of tocilizumab administration
NSAIDs high-dose refers to mean DDD \>100% and low-dose refers to mean DDD \</=100%.
Percentage of Participants by NSAIDs Dose Categories (Low-Dose and High-Dose) During 14 Days After 12-16 Weeks of Tocilizumab Administration
时间窗: 14 days after 12-16 weeks of tocilizumab administration
NSAIDs high-dose refers to mean DDD \>100% and low-dose refers to mean DDD \</=100%.
次要结局
- Percentage of Participants Who Take NSAIDs(Day -14 up to approximately Day 126)
- Percentage of NSAID Self-Medication(Day -14 up to approximately Day 126)
- Percentage of Participants Using NSAIDs by Disease Activity(Day -14 up to approximately Day 126)
- Average Daily Dose of NSAIDs(Day -14 up to approximately Day 126)
- Percentage of NSAID-Prescribers(Day -14 up to approximately Day 126)
- Percentage of Participants Who Take NSAIDs Despite the Presence of Contraindications and Risk Factors(Day -14 up to approximately Day 126)
- Percentage of Participants Who do not Take Gastro-Protection (Proton-Pump Inhibitors [PPIs]) While Using NSAIDs(Day -14 up to approximately Day 126)
- Disease Activity Score Based on 28 Joints (DAS28)(Screening (up to 28 days prior to first tocilizumab administration); Day 0 (Baseline); Weeks 6-8; Weeks 12-16)
- Percentage of Participants Using NSAIDs by Disease Duration(Day -14 up to approximately Day 126)
- Percentage of Participants Using NSAIDs by Health Assessment Questionnaire-Disability Index (HAQ-DI) Score(Day -14 up to approximately Day 126)
- HAQ-DI Score(Screening (up to 28 days prior to first tocilizumab administration); Day 0 (Baseline); Weeks 6-8; Weeks 12-16)
- Clinical Disease Activity Index (CDAI) Score(Screening (up to 28 days prior to first tocilizumab administration); Day 0 (Baseline); Weeks 6-8; Weeks 12-16)
- Simplified Disease Activity Index (SDAI) Score(Screening (up to 28 days prior to first tocilizumab administration); Day 0 (Baseline); Weeks 6-8; Weeks 12-16)
- Percentage of Participants With Adverse Events (AEs)(From Baseline up to approximately Week 28)