NCT03339089已完成不适用
Real-world Effectiveness of Adalimumab on Health Outcomes in Chinese Patients With Immune-Mediated Inflammatory Diseases
AbbVie10 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2018年5月18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
- 224
- 试验地点
- 10
- 主要终点
- Change from baseline in EuroQoL-5 Dimension (EQ-5D) index score up to Week 24
研究概览
简要总结
The objective of this study is to evaluate the effect of adalimumab on health outcomes in participants with rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis.
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
- •Participants with a diagnosis of rheumatoid arthritis, ankylosing spondylitis or plaque psoriasis
- •Decision to initiate Humira® treatment in accordance with routine medical practice and in compliance with eligibility for adalimumab based on the local label
- •Prior to any study-specific procedures, participant has voluntarily signed the authorization (or informed consent where applicable) to disclose and use anonymized personal health information after participate in this research.
排除标准
- •Inadequate response to previous standard treatment with anti-tumor necrosis factor (TNF) biological agent according to the physician's clinical judgment.
- •Participant has been treated with adalimumab within 70 days (five half-lives) prior to the Baseline Visit.
- •Participants discontinued due to adverse drug reaction of previous adalimumab treatment.
- •Participants who fulfill any of the contraindications as per adalimumab label in China.
- •Participants, who in the clinician's view, may not be able to comply with the study requirements.
结局指标
主要结局
Change from baseline in EuroQoL-5 Dimension (EQ-5D) index score up to Week 24
时间窗: From Week 0 to Week 24
The European quality of life-5 dimensions (EQ-5D) is a simple, easy to administer, standardized and self-report instrument for health status, which is applicable to a wide range of health conditions and treatment.
次要结局
- Change from Baseline in Dermatology Life Quality Index (DLQI) in participants with Psoriasis (Ps)(Up to Week 52)
- Change from baseline in Clinical Disease Activity Index (CDAI) in participants with Rheumatoid Arthritis (RA)(Up to Week 52)
- Assessing drug persistence(Up to Week 52)
- Change from baseline in Healthcare Resource Utilization (HCRU)(From Week 0 to Week 52)
- Change from baseline in EQ-5D Visual analog scale (VAS)(From Week 0 to Week 52)
- Change from baseline in Psoriasis Area and Severity Index (PASI) in participants with Psoriasis (Ps)(Up to Week 52)
- Proportion of participants achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 response in participants with Ankylosing spondylitis (AS)(Up to Week 52)
- Change from baseline in Work productivity and Activity Impairment questionnaire - Specific Health Problem (WPAI-SHP) in participants with Rheumatoid Arthritis (RA)(Up to Week 52)
- Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in participants with Ankylosing spondylitis (AS)(Up to Week 52)
- Change from baseline in EQ-5D index score up to Week 52(From Week 0 to Week 52)
- Change from baseline in Work productivity and Activity Impairment questionnaire - Specific Health Problem (WPAI-SHP) in participants with Ankylosing spondylitis (AS)(Up to Week 52)
- Percentage of participants achieving remission (CDAI<=2.8) in participants with Rheumatoid Arthritis (RA)(Up to Week 52)
- Percentage of participants achieving low disease activity (CDAI 2.8-10) in participants with Rheumatoid Arthritis (RA)(Up to Week 52)
研究者
研究点 (10)
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