An Open-label, Multi-center, Post-marketing, Observational Study to Assess the Effectiveness and Safety of Adalimumab (Humira®) in Pediatric Patients With Polyarticular Juvenile Idiopathic Arthritis (pJIA) in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change from Baseline in Physician's Global Assessment (PhGA) of Participant's Disease Activity by Visual Analog Scale (VAS)
研究概览
简要总结
Juvenile idiopathic arthritis (JIA) is the most common rheumatic disease affecting children, characterized by chronic synovitis with systemic multi-organ damage. Polyarticular juvenile idiopathic arthritis (pJIA) is a subtype of JIA defined as disease involving more than five joints in the first 6 months of disease. This study will assess how safe and effective adalimumab (Humira®) is in treating pediatric participants with pJIA in China real-world setting.
Adalimumab is an approved drug for the treatment of pJIA. Approximately 50 participants age 2 to 17 who are prescribed adalimumab for the treatment of pJIA in routine clinical practice will be enrolled at multiple sites in China.
Participants will receive adalimumab per their physician's usual prescription. Individual data will be collected for 52 weeks.
No additional study-related tests will be conducted during the routine physician visits. Only data which are routinely collected during a regular visit will be utilized for this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male or female participants aged 2-17 years old with body weight ≥ 10kg.
- •Diagnosis of polyarticular JIA by treating physician.
- •Adalimumab (Humira®) treatment is indicated as per treatment according to Chinese label.
- •Participants or their parents/legal guardians are able and willing to give assent as well as informed consent approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) if applicable according to local law, and to comply with the requirements of this study protocol and Adalimumab (Humira ®) label.
排除标准
- •Participants who cannot be treated with adalimumab according to Chinese Humira® label and by judgement of treating physician.
- •Participants who receive any biological disease-modifying anti-rheumatic drugs (bDMARDs) within 6 months prior to the screening visit or who are on concomitant use of any bDMARD.
- •Post menarche adolescent female subjects who are pregnant or breastfeeding or considering becoming pregnant during the study
- •Participant is considered by the investigator or sub-investigator, for any reason, to be an unsuitable candidate for the study.
结局指标
主要结局
Change from Baseline in Physician's Global Assessment (PhGA) of Participant's Disease Activity by Visual Analog Scale (VAS)
时间窗: Up to 52 Weeks
PhGA measured by 100 mm VAS. VAS scores range from 0 to 100 points, 0=very good and 100=very bad.
Change from Baseline in Participants Experiencing Joint Pain
时间窗: Up to 52 Weeks
Participants Experiencing Joint Pain
Number of Active Joints Count
时间窗: Up to 52 Weeks
Active joints are defined as joints with swelling not due to deformity or joints with limitation of passive motion \[LOM\] and with pain and/or tenderness. Higher scores represent higher disease activity.
Change from Baseline of C-Reactive Protein (CRP) and/or Erythrocyte Sedimentation Rate (ESR) levels
时间窗: Up to 52 Weeks
CRP and/or ESR level assessed as part of the physician's site routine car
Number of Participants with Adverse Events
时间窗: Up to 52 Weeks
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.
Change from Baseline in Physical function measured by Childhood Health Assessment Questionnaire (CHAQ)
时间窗: Up to 52 Weeks
The CHAQ assessed physical function. Scores go from 0= no disability to 3 = severe disability.
Change from baseline in dosage of corticosteroid
时间窗: Up to 52 Weeks
Change from Baseline in Participants Experiencing Joint Swelling
时间窗: Up to 52 Weeks
Participants Experiencing Joint Swelling
Change from Baseline in Parent's or Child's Global Assessment of Participant's Disease Activity (Pa/ChGA) by Visual Analog Scale (VAS)
时间窗: Up to 52 Weeks
Pa/ChGA measured by 100 mm VAS. VAS scores range from 0 to 100 points, 0=very good and 100=very bad.
Number of joints with limitation of passive motion (LOM)
时间窗: Up to 52 Weeks
Number of joints with LOM
Number of joints with pain on passive motion (POM)
时间窗: Up to 52 Weeks
Number of joints with POM
次要结局
未报告次要终点