An Open-Label Extension Study to Evaluate the Safety of Etanercept in Pediatric Subjects With Plaque Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 182
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety and efficacy of etanercept in pediatric patients with moderate to severe psoriasis.
详细描述
This study was a multicenter, open-label extension study for pediatric patients who participated in Study 20030211 (NCT00078819).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrollment on previous Amgen study 20030211 (NCT00078819)
排除标准
- •Serious or clinically significant adverse event on Amgen study 20030211 related to etanercept
研究组 & 干预措施
Etanercept
Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
干预措施: Etanercept (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: 264 Weeks
A serious adverse events is any AE that * is fatal * is life threatening * requires in-patient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * is a congenital anomaly/birth defect * other significant medical hazard. The severity assessment for adverse events and infections (except injection site reactions) was done using the Common Toxicity Criteria (CTC) Version 2.0, where Grade 3 indicates a severe toxicity (incapacitating with inability to work or do usual activity). An infectious event is an event that was considered by the investigator to be an infectious episode. An injection site reaction is a reaction at the site of the subcutaneous injection, commonly characterized, but not limited to symptoms of erythema (redness, usually raised), pruritis (itching), swelling, or pain that is persistent for 4 hours or longer.
次要结局
- Number of Participants With Clinically Significant Changes in Vital Signs(264 weeks)
- Exposure-adjusted Adverse Event Rates(264 weeks)
- Number of Participants With Grade 3 and 4 Laboratory Toxicities(264 weeks)
- Number of Participants With Injection Site Reactions(264 weeks)
- Percentage of Participants With a Psoriasis Area and Severity Index 50 Response (PASI 50)(Baseline and weeks 12, 48, 96, 144, 192, 240 and 264)
- Number of Participants Who Developed Anti-etanercept Antibodies(264 weeks)
- Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1)(Weeks 12, 48, 96, 144, 192, 240 and 264)
- Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score(Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264)
- Percentage of Participants With a PASI 75 Response(Baseline and weeks 12, 48, 96, 144, 192, 240 and 264)
- Percent Improvement From Study 20030211 Baseline in PASI Score(Study 20030211 baseline, Study 20050111 baseline and weeks 12, 48, 96, 144, 192, 240 and 264)
- Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score(Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264)
- Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score(Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264)
- Percentage of Participants With a PASI 90 Response(Baseline and weeks 12, 48, 96, 144, 192, 240 and 264)
- Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score(Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264)
- Improvement From Study 20030211 Baseline in Joint Pain(Study 20030211 baseline, Study 20050111 baseline and weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252 and 264)
- Percent Improvement From Study 20030211 Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score(Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264)
- Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score(Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264)
- Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score(Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264)