Hip Arthritis Associated With AS Efficacy and Safety of Early Treatment With Infliximab (Remicade®)
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Number of participants with clinical improvement assessed by the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) questionnaire
研究概览
简要总结
This trial is designed to measure improvement of hip involvement in patients with ankylosing spondylitis (AS) after receiving 4 doses of infliximab. Participants will receive infliximab 5 mg/kg (as an intravenous perfusion over a period of 2 hours) at Weeks 0, 2, 6, and 14, consistent with the approved dosing regimen described in the label. Participants will be evaluated for hip pain, functional capacity and stiffness before and after 14 weeks (4 doses) of treatment. Further treatment after 4 doses is based on standard clinical practice as determined by the trial site.
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
- •18 years of age or older
- •Ankylosing spondylitis (AS) diagnosis
- •Have all 3 of the following:
- •Presence of hip pain (nocturnal inflammatory pain)
- •Limitation of hip mobility
- •Patient's Global Assessment Visual Analog Scale (0-10 cm) ≥4 cm.
- •Inadequate response or intolerance to non-steroidal anti-inflammatory drugs (NSAIDs)
- •Eligible to be treated with Infliximab (Remicade®)
排除标准
- •Causes of coaxalgia other than coxitis of AS, demonstrated by images or laboratory tests
- •Women who are pregnant or nursing or plan to nurse or become pregnant
- •Serious infections like sepsis, abscesses.
- •History of or current certain infections
- •History of or current certain medical conditions
研究组 & 干预措施
Remicade
Infliximab 5 mg/kg was administered as specified in the Summary of Product Characteristics for patients with ankylosing spondylitis
干预措施: Infliximab (Drug)
结局指标
主要结局
Number of participants with clinical improvement assessed by the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) questionnaire
时间窗: Baseline and Week 15
次要结局
未报告次要终点