NCT03505892已完成不适用
A Real-world, Prospective, Observational Study to Investigate the Clinical REsponses in Ankylosing Spondylitis Patients on Adalimumab Therapy in Taiwan (EAST)
AbbVie1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2018年6月5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
- 28
- 试验地点
- 1
- 主要终点
- Percentage of participants that achieve 50% improvement of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24
研究概览
简要总结
The objectives of this prospective observational study is to explore 1-year clinical response via both Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) after initiation of adalimumab therapy in AS patients from routine clinical practices in Taiwan.
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 confirmed AS.
- •Participant will start adalimumab as treatment
- •Participant must provide the written authorization form and agree to provide personal and/or health data prior to the entry into the study.
排除标准
- •Participant has been treated with any investigational drug or biologic within a minimum of 30 days or five half-lives (whichever is longer) of the drug prior to the Baseline Visit.
- •Participants who fulfill any of the contraindications as per Humira label in Taiwan.
结局指标
主要结局
Percentage of participants that achieve 50% improvement of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24
时间窗: 24 Weeks after initiation of Humira therapy
This accounts for participants achieving 50% improvement in BASDAI.
次要结局
- Percentages of participants who achieve clinically important improvement of Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 24(24 Weeks after initiation of Humira therapy)
- Changes of the frequency of overall extra-articular manifestations (EAM) of interest(At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks))
- Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)(At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks))
- Percentages of participants who achieve major improvement of Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 24(24 Weeks after initiation of Humira therapy)
- Percentages of participants who achieve clinically important improvement of Ankylosing Spondylitis Disease Activity Score (ASDAS)(Every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks))
- Percentages of participants who achieve major improvement of Ankylosing Spondylitis Disease Activity Score (ASDAS)(Every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks))
- Percentages of participants whose disease activity states are moderate per ASDAS score(At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks))
- Changes of the respective frequency of each EAM(At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks))
- Changes in the percentage of participants who have enthesitis of the plantar fascia or Achilles tendon(At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks))
- Percentage of participants that achieve 50% improvement of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(Every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks))
- Percentages of participants whose disease activity states are inactive per ASDAS score(At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks))
- Change in Tender Joint Counts (TJC)(At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks))
- Change in Swollen Joint Counts (SJC)(At Week 0 (Baseline) and every 12 weeks' follow-up after initiation of Humira therapy (approximately up to 58 weeks))
研究者
研究点 (1)
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