NCT01844518已完成3 期
A Phase 3 Multi-center, Open-Label Study to Evaluate Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents With Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to Biologic or Non Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)
Bristol-Myers Squibb57 个研究点 分布在 11 个国家目标入组 219 人开始时间: 2013年8月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 219
- 试验地点
- 57
- 主要终点
- Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17
研究概览
简要总结
The purpose of this study is to estimate Abatacept steady-state trough concentration (Cmin) at Day 113 in children and adolescents with pJIA
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
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •JIA subjects (male or female), ages 2-17 years with active disease who had an insufficient therapeutic response or intolerance to at least one non biologic DMARD or Tumor Necrosis Factor (TNFα) antagonists for at least 3 months prior to screening
- •Subjects with TNFα inadequate response (or prior biologic) will be restricted to 30% of the population
- •Subjects must have a history of at least 5 joints with active disease and must have currently active articular disease with ≥2 active joints and ≥2 joints with limitation of motion.
排除标准
- •Subjects with other rheumatic diseases or major chronic inflammatory/immunologic diseases, active uveitis, systemic JIA with active systemic features (within a period of 6 months prior to enrollment), persistent Oligoarthritis JIA, or failed 3 or more TNFα antagonists or other biological DMARDs will be excluded.
- •Active systemic disease: (ie, extra-articular features of systemic JIA including fever, rash, organomegaly) within a period of 6 months prior to randomization.
- •Subjects who have failed more than two TNFα antagonists or other biologic DMARDs
研究组 & 干预措施
Short and Long Terms: Orencia
Experimental
Short Term: Orencia 50 mg/mL, 87.5 mg/mL, 125 mg/mL pre-filled syringes subcutaneously (0.4 mL/0.7 mL/1.0 mL) weekly for 4 months
Long term: Orencia 50 mg/mL, 87.5 mg/mL, 125 mg/mL pre-filled syringes subcutaneously (0.4 mL/0.7 mL/1.0 mL) weekly for 20 months
干预措施: Abatacept (Biological)
结局指标
主要结局
Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17
时间窗: Day 113
Trough concentration of abatacept (reported as geometric mean of Cmin) in all pharmacokinetic (PK)-evaluable participants. Cmin is reported in microgram per milliliter (µg/mL). Desired target therapeutic Cmin should be \>= 10 µg/mL.
次要结局
- Number of Participants With Adverse Events (AEs), Deaths, Serious AEs and AEs Leading to Discontinuation in the Cumulative Period(From first dose up to 56 days after last dose ( up to approximately 2 years))
- Number of Participants With Positive Immunogenicity Response in the Short-Term Period for the 6-17 Year Age-Group Cohort(From first dose up to start of LT (for those continuing in long-term) or up to 168 days after the lost dose of study medication in the ST period (for those not entering in the long-term))
- Number of Participants With Adverse Events (AEs), Deaths, Serious AEs (SAEs) and AEs Leading to Discontinuation in the Short-Term Period for the 6-17 Year Age-Group Cohort(From first dose up to 56 days post last dose in the short-term period (initial 4-month treatment period))
- Number of Participants With Positive Immunogenicity Response in the Cumulative Period(From first dose up to 6 months following treatment discontinuation (up to approximately 2 years))
- Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17 by Weight Tier Dose(Days 57, 85 and 113)
- Percentage of Participants (Ages 6 to 17) Achieving American College of Rheumatology Pediatric 30 Response (ACRp30)(Day 113)
研究者
研究点 (57)
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