Musculoskeletal Ultrasound as a Marker of Therapeutic Response to Abatacept in Rheumatoid Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- 12 Month Change in 7-Joint Ultrasound (US) Inflammatory Score
研究概览
简要总结
Rheumatoid arthritis (RA) is a chronic inflammatory disease (a long-lasting disease causing pain and swelling) associated with significant health problems. It is a difficult disease to manage as the disease is often unpredictable. RA causes inflammation (swelling) of the joints that can cause joint damage, deformity, and progressive disability and impairment. It is estimated that 1% of the world's population suffers from this disease.
The purpose of this research study is to determine if a change in inflammation seen on the ultrasound is a good indicator of how subjects' rheumatoid arthritis is responding to treatment of subcutaneous abatacept at 3 weeks, 3 months, 6 months, and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Over 18 years old
- •Has a diagnosis of rheumatoid arthritis
- •Stable DMARDs for at least 1 month (methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine)
- •Disease activity score DAS28/ESR > 3.2 or all must be met: TJC (tender joint count)>=4, SJC (swollen joint count)>=4
- •Must be able to understand information in the Informed Consent and comply with study requirements
- •Total ultrasound synovitis (inflammation of joint-lining membrane) power Doppler score >=1 for at least 2 joints and total synovitis score >=1 for at least 1 joint
排除标准
- •Current or prior use of biologic drugs (TNF inhibitors, IL-6 inhibitors, CD20 inhibitors, IL-1 inhibitors, etc.)
- •Pregnancy or breast feeding
- •Daily prednisone > 10mg (stable dose for at least 1 month)
- •Intra-articular steroid injection of the wrist or joints within last 2 months
- •History of a concomitant autoimmune disease such as lupus, psoriatic arthritis
- •History of cancer
- •Previous exposure to abatacept
研究组 & 干预措施
Subcutaneous Abatacept
All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
干预措施: abatacept (Drug)
结局指标
主要结局
12 Month Change in 7-Joint Ultrasound (US) Inflammatory Score
时间窗: baseline, 12 months
The 7-joint US inflammatory score includes the addition of synovial hypertrophy scores and power doppler scores.
次要结局
- 12 Month Change in Power Doppler Ultrasound (PDUS) Scores(baseline, 12 months)
- 12 Month Change in Gray-scale Ultrasound (GSUS)(baseline, 12 months)
研究者
Dr. Veena Ranganath
M.D., Assistant Clinical Professor
University of California, Los Angeles