A Multi-center, Open Label, Random Clinical Trial of Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing Spondylitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- the SPARCC score of spine and SI joint
研究概览
简要总结
This is a multi-center, open label, randomized clinical trial of etanercept and celecoxib alone/combined treatment in effectiveness and safety on active ankylosing spondylitis (AS). Subjects will be randomly assigned in a 1:1:1 ratio to one of the three groups (celexocib 200mg bid, etanercept 50mg qw, etanercept plus Celecoxib group) for 54 weeks. Primary endpoints are the magnetic resonance imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) score of sacroiliac(SI) joint and spine, as well as the Assessment of SpondyloArthritis International Society (ASAS)20 response rate at 52 weeks.
详细描述
A multi-center, open label, randomized clinical trial evaluating the effectiveness and safety of etanercept and celecoxib alone/combined treatment will be conducted on active ankylosing spondylitis (AS) patients. Disease activity is defined as fulfilling three aspects below: BASDAI ≥ 4 or ASDAS≥ 2.1；CRP>6 mg/L or ESR 28 mm/1st hour；more than 2 and less than 16 syndesmophyts between cervical spine and lumber spine detected by X-ray. All patients were randomly assigned in a 1:1:1 ratio to one of the three treatment groups：celecoxib 200mg bid，etanercept 50mg qw and combined therapy for 52 weeks. Primary endpoints are the magnetic resonance imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) score of sacroiliac(SI) joint and spine, as well as the Assessment of SpondyloArthritis International Society (ASAS) 20 response rate at 52 weeks. Key secondary Endpoints include the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS), Spondyloarthritis Research Consortium of Canada (SPRACC) SI joint structural score (SSS), BASDAI, ASDAS, ASAS40, ASAS70 and ASAS5/6 response rate at 52 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 65 years
- •Meet 1984 NewYork modified criteria for AS
- •BASDAI≥4 or ASDAS score ≥ 2.1
- •CRP>6 mg/L or ESR>28 mm/h
- •Syndesmophyte quantity ≥2 and <16 of spine
- •Sexually active women of childbearing potential must agree and commit to use a medically accepted form of contraception
- •No active or latent tuberculosis infection.
排除标准
- •Pregnant or breastfeeding women
- •current or previous history of psoriasis or inflammatory bowel disease.
- •infection with clinical significance within 24 weeks before screening
- •receipt any bio-agents treatment within 12 weeks before screening
- •corticosteroids intra-articular injections in last 3 months before the trial
- •Significant concurrent medical events including: Gastrointestinal ulcer, myocardial infarction within 12 months before the screening visit, unstable angina pectoris, congestive heart failure.
- •Alcohol and drug abuse
研究组 & 干预措施
celebrex
celebrex capsule, 0.2 gram bid, 52 weeks
干预措施: celebrex (Drug)
Enbrel
etanercept injection, 25mg per injection, 50mg/week, 52 weeks
干预措施: Enbrel (Drug)
Enbrel plus Celebrex
50mg/week Enbrel by hypodermic injection plus Celebrex 0.2 gram bid, 52 weeks
干预措施: Enbrel plus Celebrex (Drug)
结局指标
主要结局
the SPARCC score of spine and SI joint
时间窗: 52th weeks
the MRI SPARCC score of spine and SI joint on 52th week
ASAS20 response rate
时间窗: 52th week
ASAS20 response rate on 52th week
次要结局
- mSASSS score of spine(52th week)
- ASDAS(52th week)
- ASAS40 response rate(52th week)
- ASAS70 response(52th week)
- Spondyloarthritis Research Consortium of Canada (SPRACC) SI joint structural score (SSS)(52th week)
研究者
Gu Jieruo
Department of Rheumatology, Third Affiliated Hospital of Sun Yat-sen University
Sun Yat-sen University