A Long-Term Non-Interventional Postmarketing Study to Assess Safety and Effectiveness of Humira® (Adalimumab) in Pediatric Patients With Moderately to Severely Active Crohn's Disease (CD) - CAPE
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,446
- 试验地点
- 148
- 主要终点
- Number of treatment-emergent other AESI per 100 PYs
研究概览
简要总结
This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in pediatric patients with moderately to severely active CD who are treated as recommended in the local product label.
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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For a patient enrolling into the HUMIRA treatment group; A pediatric patient between the ages of 6 and 17 years inclusive at the time of enrollment, diagnosed with moderately to severely active CD who has been prescribed Humira therapy according to the routine clinical practice.
- •For a patient enrolling into the immunosuppressant therapy treatment group; A pediatric patient between the ages of 6 and 17 years inclusive at the time of enrollment, diagnosed with moderately to severely active CD who has been prescribed azathioprine, 6-mercaptopurine or methotrexate.
- •Parent or guardian; or patient (if 18 years of age or older at enrollment and rolling over from an AbbVie-sponsored investigational Pediatric CD investigation trial) has voluntarily signed and dated an Authorization for Use/Disclosure of Data (AUDD)/informed consent form (ICF) after the nature of the registry has been explained and the patient, patient's parent or legal guardian has had the opportunity to ask questions.
排除标准
- •Patients should not be enrolled into the registry if they are currently being treated with any investigational agents or are receiving any investigational procedures.
- •Patients should not be enrolled into the immunosuppressant therapy treatment group if they require ongoing treatment with approved biologic agents including HUMIRA.
结局指标
主要结局
Number of treatment-emergent other AESI per 100 PYs
时间窗: Up to 5 years
Number of treatment-emergent AESI per 100 PYs of infections and malignancies
时间窗: Up to 10 years
Number of treatment-emergent SAEs per 100 patient years (PYs)
时间窗: Up to 10 years
Percentage of subjects with AESI of infections, malignancies, and pregnancies
时间窗: Up to 10 years
Percentage of subjects with SAEs
时间窗: Up to 10 years
Number of subjects with other AESI
时间窗: Up to 5 years
Number of subjects with AESIs other than infections and malignancies
Percentage of subjects with other AESI
时间窗: Up to 5 years
Percentages of subjects with AESIs other than infections and malignancies
Number of subjects with Serious Adverse Events (SAEs)
时间窗: Up to 10 years
Number of subjects with Adverse Events of Special Interest (AESI) of infections, malignancies, and pregnancies
时间窗: Up to 10 years
次要结局
- Short Pediatric Crohn's Disease Activity Index (sh-PCDAI)(Up to 5 years)
- IMPACT III(Up to 5 years)
- Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ)(Up to 5 years)
- Work Productivity and Activity Impairment (WPAI) questionnaire(Up to 5 years)
- Physician's Global Assessment of Disease Activity (PGA)(Up to 5 years)