A Trial of Active Psoriatic Arthritis (PsA): Randomizing to Treat to a Target vs. Usual Care
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 7
- 主要终点
- Percentage of patients achieving low DAS
研究概览
简要总结
Canadian Rheumatologists will be randomized to treat their participants with active Psoriatic Arthritis to a target (disease activity score <2.6), or as per their routine care. The aim of this study is to determine whether treating to a target results in greater disease improvement than treating patients using routine care.
详细描述
Canadian Rheumatologists will be randomized to treat their participants with active Psoriatic Arthritis to a target (disease activity score <2.6), or as per their routine care. The aim of this study is to determine whether treating to a target results in greater disease improvement than treating patients using routine care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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
- •Psoriatic Arthritis as diagnosed by a rheumatologist and meeting ACR classification criteria for PsA or CASPAR criteria
- •The subject must provide written informed consent for participation in the study before any study specific procedures are performed
- •Subject has 3 or more SJC on 28 joint count
- •Age >=18
排除标准
- •Subject has a history of being non-compliant
- •Serious concomitant illnesses that in the investigator's opinion negate ability to optimally treat the patient
- •If treating with TNF inhibitor, positive PPD > 5mm who have not received INH for recommended course or untreated TB (ie CXR evidence of latent infection). Usual screening is in place for standard of care.
- •Pregnancy, breast-feeding or considering pregnancy over the next 12 months
结局指标
主要结局
Percentage of patients achieving low DAS
时间窗: Month 9 Visit
The primary outcome measure will be the percentage of patients achieving low Disease Activity Score (DAS\<2.6) in each patient group (Intensive Care vs. Routine Care) at the end of the study.
次要结局
- Percentage of Patients achieving ACR 20, 50, and 70(Month 3 Visit, Month 6 Visit, Month 9 Visit)
- Time to achieving DAS28<2.6(Month 3 Visit, Month 6 Visit, and Month 9 Visit)
- Absolute change in DAS28(Month 3 Visit, Month 6 Visit, Month 9 Visit)
- Percentage of patients achieving PsARC(Month 3 Visit, Month 6 Visit, Month 9 Visit)
- Absolute change in HAQ-DI(Month 3 Visit, Month 6 Visit, Month 9 Visit)