A Double-blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects With Enthesitis Related Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 主要终点
- Percent Change in Number of Active Joints With Arthritis From Baseline to Week 12
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of adalimumab given subcutaneously every other week (eow) as compared to placebo in pediatric subjects with Enthesitis Related Arthritis (ERA).
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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Enthesitis Related Arthritis (ERA) as defined by International League of Associations for Rheumatology (ILAR);
- •Disease activity defined as at least 3 active joints and evidence of enthesitis in at least one location;
- •Inadequate response or intolerance to at least one nonsteroidal anti-inflammatory drug and at least one disease modifying anti-rheumatic drug, either sulfasalazine or methotrexate.
排除标准
- •Any ILAR Juvenile Idiopathic Arthritis (JIA) subtype other than ERA;
- •Psoriasis or a history of psoriasis in the patient or first-degree relative;
- •Presence of Immunoglobulin M (IgM) rheumatoid factor;
- •Presence of systemic JIA;
- •History of inflammatory bowel disease;
- •previous biologic therapy including anti-tumor necrosis factor (anti-TNF) therapy with a potential impact on pediatric ERA;
- •Infection(s) requiring treatment with IV anti-infectives within 30 days prior to Baseline or oral anti-infectives within 14 days prior to Baseline.
结局指标
主要结局
Percent Change in Number of Active Joints With Arthritis From Baseline to Week 12
时间窗: Baseline and Week 12
A joint assessment was recorded at all study visits to assess the number of active joints. A total of 72 joints were assessed for swelling not due to deformity or joints with loss of motion (LOM) plus pain and/or tenderness. Total possible scores ranges from 0 (no active joints) to 72 (all active joints). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Last Observation Carried Forward (LOCF) was used for missing data.
次要结局
- Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 30% Response (ACR Pedi30)(Baseline and Week 12)
- Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 50% Response (ACR Pedi50)(Baseline and Week 12)
- Number of Sites of Enthesitis: Change From Baseline to Week 12(Baseline and Week 12)
- Swollen Joint Count (SJC68): Change From Baseline to Week 12(Baseline and Week 12)
- Tender Joint Count (TJC72): Change From Baseline to Week 12(Baseline and Week 12)
- Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 70% Response (ACR Pedi70)(Baseline and Week 12)
- Number of Participants With Adverse Events (AEs)(Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks))