A Phase 3 Safety and Efficacy Study of Etanercept In Children With Systemic Onset Juvenile Rheumatoid Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Amgen
- 入组人数
- 19
- 主要终点
- Number of Participants in Part 2 With Disease Flare
研究概览
简要总结
The primary objective of this study was to determine the efficacy of etanercept in pediatric patients with systemically active system onset juvenile rheumatoid arthritis (SOJRA).
详细描述
Participants were to receive etanercept at a dose of 0.4 mg/kg twice weekly in Part 1A. Participants who had a partial response (not able to reduce prednisone dose by 50% of the baseline dose in 5 months) while on 0.4 mg/kg twice weekly etanercept in Part 1A were to enter Part 1B for up to 4 months and were to have the dose of etanercept increased to 0.8 mg/kg twice weekly. Participants who did not meet the response criteria in Part 1A or Part 1B of the study were to be withdrawn from the study as non-responders. Participants who responded in either Part 1A or Part 1B were randomized into Part 2, where they received etanercept or matching placebo in a double-blind manner twice weekly for up to 3 months. In Part 2, participants were stratified by the dosage of etanercept (0.4 mg/kg or 0.8 mg/kg) they were receiving in Part 1A or Part 1B. Participants could enter Part 3, the open-label re-treatment portion of the study, only if they had been entered into Part 2 of the study and had either flared in Part 2 or had completed 3 months of treatment in Part 2. The maximum time participants could receive etanercept in Part 2 and Part 3 combined was 12 months.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Part 1: Etanercept
Participants received 0.4 mg/kg etanercept administered subcutaneously twice a week for up to 6 months in Part 1A.
Participants who had a partial response entered Part 1B and received 0.8 mg/kg etanercept twice weekly for up to 4 months.
干预措施: Etanercept (Drug)
Part 2: Placebo
Participants who met response criteria in Part 1 were randomized to receive placebo twice a week for up to 3 months.
干预措施: Placebo (Drug)
Part 2: Etanercept
Participants who met response criteria in Part 1 were randomized to continue receiving etanercept twice a week at the same dose as in Part 1 (0.4 or 0.8 mg/kg) for up to 3 months.
干预措施: Etanercept (Drug)
Part 3:
Participants who experienced a flare or completed 3 months of treatment in Part 2 entered Part 3 and received open-label treatment with etanercept at the same dose as in Part 1 (0.4 or 0.8 mg/kg) for up to a maximum of 12 months, including treatment in Part 2.
干预措施: Etanercept (Drug)
结局指标
主要结局
Number of Participants in Part 2 With Disease Flare
时间窗: 3 months during Part 2 (depending on the timing of response, entry into Part 2 was between study months 3 and 10)
Disease flare was defined as the presence of: * 1 major flare criterion plus 1 minor flare criterion or 1 lab criterion, OR * 2 minor flare criteria plus 2 lab criteria Major Criteria: * Fever of SOJRA, defined as a spike in axillary temperature ≥ 100°F (38°C) for ≥ 2 days per week in the prior 2 weeks or 8 days during the prior month * Symptomatic serositis documented by x-ray or other imaging modality Minor Flare Criteria * Rash of SOJRA, documented in the daily diary * Splenomegaly defined as spleen palpable \> 2 cm below the left costal margin * Lymphadenopathy defined as ≥ 1 cm in \> 1 node area * Arthritis defined as ≥ 2 active joints with swelling not due to deformity, or if swelling is absent, then 2 joints with loss of motion with pain on passive motion and/or warmth. Laboratory Criteria: All labs should be outside the normal range and with 30% worsening: * Albumin * Platelet count * Hemoglobin * C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR)
次要结局
- Change From Baseline in C-reactive Protein (CRP) Levels in Part 2(Baseline and months 5, 6, 7, 8, and 9)
- Number of Participants With Adverse Events(Part 1A, maximum duration on treatment was 207 days; Part 1B, maximum duration on treatment was 120 days; Part 2, maximum duration on treatment was 88 days; Part 3, maximum duration on treatment was 130 days; plus 30 days after last dose of study drug.)
- Time to Flare in Part 2(From first dose in Part 1 to the end of Part 2 (up to 13 months))
- Change From Baseline in Physician Global Assessment of Disease Severity in Part 1(Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9)
- Change From Baseline in Physician Global Assessment of Disease Severity in Part 2(Baseline and months 5, 6, 7, 8, and 9)
- Change From Baseline in Patient's/Parent's Global Assessment in Part 1(Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9)
- Change From Baseline in Patient's/Parent's Global Assessment of Disease Severity in Part 2(Baseline and months 5, 6, 7, 8, and 9)
- Change From Baseline in Number of Active Joints in Part 1(Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9)
- Change From Baseline in Number of Active Joints in Part 2(Baseline and months 5, 6, 7, 8, and 9)
- Change From Baseline in Number of Joints With Limitation of Motion in Part 1(Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9)
- Change From Baseline in Number of Joints With Limitation of Motion in Part 2(Baseline and months 5, 6, 7, 8, and 9)
- Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 1(Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9)
- Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2(Baseline and months 5, 6, 7, 8, and 9)
- Change From Baseline in C-reactive Protein (CRP) Levels in Part 1(Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9)