Safety & Efficacy of Genakumab in Patients With Frequent Flares
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 313
- 试验地点
- 1
- 主要终点
- The change in the gout pain intensity in the target joint measured by VAS
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Genakumab Injection in patients with Gouty Arthritis (GA).
详细描述
A multicenter, randomized, double-blind, double-dummy, active-controlled study was to demonstrate the efficacy of Genakumab versus compound betamethasone injection in adult patients with frequent gouty arthritis attacks in whom non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine are contraindicated, are not tolerated, or do not provide an adequate response.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 years ≤ age ≤75 years
- •BMI≤40kg/m2
- •Meeting ACR 2015 preliminary criteria for the classification of acute arthritis of primary gout.
- •Start of acute gout flare within 4 days prior to enrolled
- •History of ≥ 2 gout flares within the 12 months prior to study start
- •Evidence of contraindication (absolute or relative), or intolerance, or lack of efficacy for either NSAIDs and/or colchicines
- •Baseline pain intensity ≥ 50 mm on the 0-100 mm visual analog scale (VAS)
排除标准
- 未提供
研究组 & 干预措施
Genakumab
Genakumab 200mg s.c
干预措施: placebo for Diprospan (Drug)
Genakumab
Genakumab 200mg s.c
干预措施: genakumab (Drug)
Diprospan
Diprospan 7mg im
干预措施: placebo for genakumab (Drug)
Diprospan
Diprospan 7mg im
干预措施: Diprospan (Drug)
结局指标
主要结局
The change in the gout pain intensity in the target joint measured by VAS
时间窗: 72 hours post-dose
The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. In this study patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0mm) to unbearable pain (100mm), at 72 hours post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left.
Time to first new flare
时间窗: 12 weeks
次要结局
- Patients assessment of gout pain intensity in the target joints measured by VAS(0-100mm)(At 6, 24, 48, and 72 hours and 7 days post-dose)
- The change in the gout pain intensity in the target joint measured by VAS.(At 6, 24, 48, and 72 hours and 7 days post-dose)
- The number of patients with at least 1 new gout flare(12 weeks, 24 weeks, 48 weeks)
- Time to at Least a 50% Reduction in Baseline Pain Intensity(7 days)
- Percent Patients Who Took Rescue Medication(24 weeks,48 weeks)
- Time to first flare(24 weeks, 48 weeks)
- Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)(24weeks, 48weeks)
- Immunogenicity The incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibody(24 weeks, 48 weeks)
- Genakumab Pharmacokinetics (PK) Serum Concentration During the Treatment Period(2 hours pre-dose, Days 4，8，29，57，85，169，253 days post-dose)