NCT01559038已完成不适用
Canadian Humira Post Marketing Observational Epidemiological Study Assessing Effectiveness in Psoriatic Arthritis (Complete-PsA)
AbbVie (prior sponsor, Abbott)41 个研究点 分布在 1 个国家目标入组 483 人开始时间: 2012年2月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 483
- 试验地点
- 41
- 主要终点
- Change in the Disease Activity Score - 28 (DAS-28)
研究概览
简要总结
The current study will assess the real - life effectiveness of adalimumab in the management of articular and dermatological manifestations of moderate to severe Psoriatic Arthritis (PsA).
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult >= 18 years old
- •Has provided written informed consent allowing the use of their data for the study and providing permission for contact by the study personnel
- •Active Psoriatic Arthritis (PsA) with three (3) or more tender and swollen joints as well as active psoriatic skin lesions or confirmed history of psoriasis
- •Inadequate response or non-tolerant to current disease-modifying antirheumatic drugs (DMARD) based treatment for PsA
排除标准
- •Currently participating in another prospective study including controlled clinical trials and observational studies
- •Patient cannot or will not sign informed consent
- •Stable disease with adequate tolerance and response to current treatment and no change in treatment is indicated
- •Previous treatment with anti-tumor necrosis factor (anti-TNF) or other biologic agent
结局指标
主要结局
Change in the Disease Activity Score - 28 (DAS-28)
时间窗: Every 3 months up to 6 months, then every 6 months up to 24 months
The DAS - 28 is calculated using the number of swollen (SJC) and tender (TJC) joints out of 28, the erythrocyte sedimentation rate (ESR) and the patient's global assessment of disease activity using a 100 mm visual analogue scale (VAS)
次要结局
- Duration of Morning Stiffness (min)(Every 3 months up to 6 months, then every 6 months up to 24 months)
- Dermatology Life Quality Index (DLQI)(Baseline, month 6, month12, month 24)
- Health Assessment Questionnaire - Disability Index (HAQ-DI)(Every 3 months up to 6 months, then every 6 months up to 24 months)
- Patient Global Assessment of Disease Activity (VAS and 5 Point Scale)(Every 3 months up to 6 months, then every 6 months up to 24 months)
- Physician Global Assessment of Disease Activity (VAS and 5 Point Scale)(Every 3 months up to 6 months, then every 6 months up to 24 months)
研究者
研究点 (41)
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