Efficacy and Safety Study of Anbainuo in Chinese Patients With Rheumatoid Arthritis/ Ankylosing Spondylitis in the Real World: a Prospective, Open-label, Multi-center Observational Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 主要终点
- Percent of participants achieving bath ankylosing spondylitis disease activity index (BASDAI) 50 response.
研究概览
简要总结
TNF- α receptor inhibitors have been used widely in practice and are well developed in China. Anbainuo is a bio-similar recombinant TNF-α receptor: IgG Fc fusion protein, approved in 2015. Up to now, Anbainuo is well applied in patients with rheumatoid arthritis (RA) or ankylosing spondylitis (AS). Although the phase II and III clinical trials both indicated that Anbainuo can effectively control the disease activity with good tolerance and safety in RA and AS patients, there is no sufficient clinical evidence in the real world. Thus, the objective of this study is to evaluate, under the actual conditions of use, dosing patterns of Anbainuo. Investigators plan to recruit 1000 adult patients with RA or AS and to follow them for 48 weeks. It is hypothesized that this study would reflect real clinical conditions (efficacy and safety assessment) of using Anbainuo in RA and AS patients.
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
- •meet the diagnostic criteria of the American College of Rheumatology (ACR) (1987);
- •or meet the diagnostic criteria of ankylosing spondylitis (New York, modified in 1984);
- •older than 18;
- •Prepare to or already start to use Anbainuo.
排除标准
- •any acute or chronic infection or the history of active tuberculosis
- •pregnant women or breast feeding women;
- •malignant tumor;
- •moderate to severe congestive heart failure (New York Heart Association, 3-4 grade);
- •allergic to Anbainuo.
结局指标
主要结局
Percent of participants achieving bath ankylosing spondylitis disease activity index (BASDAI) 50 response.
时间窗: Up to week 48
BASDAI subject assessment of discomfort, pain and fatigue was measured using a 100 millimeter Visual Analog Scale (VAS); range: 0=none to 100=very severe. BASDAI 50 response defined as at least a 50 percent (%) improvement (decrease) from baseline to observation (last observation carried forward) in the BASDAI. Baseline score minus score at observation divided by Baseline score \* 100 = \>=50%.
Percent of participants achieving clinical remission defined as a DAS28 ≥1.2
时间窗: Up to week 48
The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response (APR) determined as erythrocyte sedimentation rate (ESR), and general health (GH), both scored 1-100 (higher scores indicate higher disease activity). DAS28 was calculated according to the following formula: DAS28 equals (=) \[0.56 multiplied by (\*) the square root (√) of TJC\] plus (+) \[0.28 \* √ of SJC\] + (0.70 \* the natural logarithm (ln) ESR in millimeters per hour (mm/h)\] + \[0.014 \* GH in mm visual analogue assessment (VAS)\]. A negative change from randomization indicated improvement.
次要结局
- Change From baseline in the modified total Sharp score to week 48(baseline and week 48)