NCT00356356已完成3 期
Open-label, Long-term Extension Study of Etanercept in the Treatment of Patients With Ankylosing Spondylitis Who Participated in Protocol 16.0037
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 257
- 主要终点
- Treatment Response (using ASAS criteria) of at least 20% and absolute improvement of at least 10 units on a 0-100 scale in at least 3 of the 4 domains
研究概览
简要总结
The purpose of this study was to evaluate extended safety and efficacy of etanercept in adults with Ankylosing Spondylitis.
详细描述
This multicenter, open-label extension study will evaluate the safety and clinical benefit of etanercept in the treatment of Ankylosing Spondylitis in subjects previously enrolled in Protocol 16.0037.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects completing 24 weeks of study drug in protocol 16.0037 qualify to enroll into this study Other patients to meet the following criteria:
- •Negative pregnancy test
- •Subjects agree to use appropriate contraception throughout study
- •Should be able to self-inject study drug or have someone who can do so
- •Capable of understanding protocol and willing to provide written informed consent
排除标准
- •Any change in NSAID or prednisone dose within 2 weeks of baseline
- •Any change in hydroxychloroquine, sulfasalazine, or MTX dose within 4 weeks of baseline
- •Use of DMARDs other than those mentioned above, within 4 weeks of enrollment
- •Previous receipt of ani-TNF agents, other than etanercept
- •Receipt of any other investigational drug within 30 days of baseline
- •Grade 3 or 4 adverse event attributed to etanercept which recurred when etanercept was resumed
- •Abnormality in chemistry or hematology profiles or significant concurrent medical events.
研究组 & 干预措施
All subjects
Experimental
257 subjects
干预措施: Etanercept (Drug)
结局指标
主要结局
Treatment Response (using ASAS criteria) of at least 20% and absolute improvement of at least 10 units on a 0-100 scale in at least 3 of the 4 domains
时间窗: Up to 4 years
Absence of deterioration (using ASAS criteria) of at least 20% and absolute improvement of at least 10 units on a 0-100 scale in the potential remaining ASAS domain
时间窗: Up to 4 years
次要结局
- DXA and MRI scans (at selected sites)(Up to 144 weeks)
- X-rays of cervical spine and lumbosacral spine(Up to 4 years)
- Type and grade of toxicities(Up to 4 years)
- ASAS Response Criteria at weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, and the ASAS Response Criteria at 50% and 70% levels at weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, and 144.(Up to 4 years)
- Frequency and time to partial remission as defined in Anderson, 2001: Value of <20 (on a scale of 0-100) in each of the following 4 domains: VAS Patient Global Assessment, VAS Pain Score, BASFI, and BASDAI morning stiffness-related scores(Up to 4 years)
- Spinal mobility measured with Schober's test, chest expansion, and occiput to wall distance(Up to 120 weeks)
- Complete joint assessment(Up to 120 weeks)
- Laboratory assessment of inflammation using CRP(Up to 120 weeks)
- Ability to reduce and discontinue concomitant NSAIDs, prednisone, hydroxychloroquine, sulfasalazine, and methotrexate(Up to 4 years)
研究者
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