Success and Failure of Biological Therapy: Predictors of Response in Patients With Active Ankylosing Spondylitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Percentage of Participants With a Clinical Response
研究概览
简要总结
The objective of this observational study is to determine the incidence of response in patients with predictive factors of major clinical response in active ankylosing spondylitis (AS) in patients who start anti-tumor necrosis factor (anti-TNF) therapy and correlate these findings in patients who switch from one to another anti-TNF due to inefficacy under usual clinical practice conditions in Spain.
详细描述
A sample size of 240 patients, 120 of them exposed and 120 not exposed to factors of response. Sample will be obtain from all the consecutive patients attending the rheumatology settings included in the study who fulfill the inclusion criteria
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
- •Patients diagnosed of active AS who will start anti-TNF therapy following standard clinical practice as per summary of product characteristics doses.
- •>18 years, both genders, any disease duration
- •Signature of informed consent
排除标准
- •Previous treatment with biological therapies
- •Active tuberculosis infection (local guidelines for appropriate screening and treatment of tuberculosis in the setting of anti-TNF therapy must be followed)
结局指标
主要结局
Percentage of Participants With a Clinical Response
时间窗: Week 16
Assessment of clinical response was as per investigator's discretion. Investigators were provided with the final consensus document of the Spanish Society for Rheumatology (SER) for the biological treatment of spondyloarthropathies as a guide for defining active AS, the indication of treatment with biological therapy and the assessment of response to it.
次要结局
- Percentage of Participants With High Probability of Response and no Response Who Received Second Anti-TNF Treatment(Week 32)
- Percentage of Participants With Low Probability of Response and no Response Who Received Second Anti-TNF Treatment(Week 32)
- Percentage of Participants With Low Probability of Response and a Clinical Response at Week 16(Week 16)
- Percentage of Participants With Assessment in Ankylosing Spondylitis (ASAS) 40 Response at Week 16(Week 16)
- Percentage of Participants Who Switched to Another Anti-TNF Treatment Due to Lack of Efficacy(Week 16)
- Percentage of Participants With ASAS 40 Response Who Started Second Anti-TNF Treatment and Were Treated for at Least 16 Weeks(Week 32)