A Multi-Center Registry Study of Infliximab in the Treatment of Chinese Children With Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 5
- 主要终点
- Percentage of Participants with Clinical Response at Week 14
研究概览
简要总结
The main purpose of this study is to record the use of Infliximab (IFX) in the treatment of Chinese children with Crohn's disease (CD) in routine clinical practice and to summarize the clinical efficacy and safety of IFX in the treatment of pediatric CD.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Must have a confirmed diagnosis of Crohn's disease
- •Must sign, and their legal guardians/legally-acceptable representative where applicable must sign, a participation agreement/ICF allowing data collection and source data verification in accordance with local requirements
- •First-time received IFX treatment
排除标准
- •History of medical contraindications for Infliximab (IFX), example. serious infections, active tuberculosis (TB), lymphoma and other malignancies, moderate to severe heart failure, hypersensitivity to inactive components of the product or to any murine proteins
- •Previous exposure to Infliximab or any other biologics
- •Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 90 days before the start of the study or the first data collection time point
- •Currently enrolled in an investigational study
- •Have other Crohn's-like disease that are associated with mono-genetic immune disorders
研究组 & 干预措施
Infliximab
Participants with pediatric Crohn's disease (CD) who were treated with Infliximab (IFX) and signed the Informed Consent Form (ICF) for the study will be enrolled case by case. Each participants will be followed up for at least 30 weeks. After 30 weeks, participants continuing IFX treatment will be followed up, with a maximum follow-up period of 102 weeks. The primary data source will be participants medical records for all data entered into the CRF.
干预措施: Infliximab (Drug)
结局指标
主要结局
Percentage of Participants with Clinical Response at Week 14
时间窗: Week 14
Percentage of participants with clinical response at week 14 will be reported. Clinical response is defined as a decrease of PCDAI \>=15 and total PCDAI \<=30.
Number of Participants with Adverse Events (AE) as a Measure of Safety and Tolerability
时间窗: Up to 102 weeks
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
次要结局
- Change from Baseline in Hemoglobin Levels at Week 14(Baseline and Week 14)
- Percentage of Participants with Clinical Remission at Week 14(Week 14)
- Change from Baseline in Acute Response Indicators at Week 14(Baseline and Week 14)
- Change from Baseline in Platelet Count at Week 14(Baseline and Week 14)
- Percentage of Participants with Clinical Response at Week 30(Week 30)
- Percentage of Participants with Endoscopic Remission at Week 30(Week 30)
- Change from Baseline in Body Mass Index (BMI) Z-Scores at Week 30(Baseline and Week 30)
- Change from Baseline in White Blood Cells Countat Week 14(Baseline and Week 14)
- Percentage of Participants with Clinical Remission at Week 30(Week 30)
- Change from Baseline in Height Z-Scores at Week 30(Baseline and Week 30)
- Change from Baseline in Albumin Levels at Week 14(Baseline and Week 14)