Assessing Long-term Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions-LEA
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 62
- 试验地点
- 24
- 主要终点
- Time to loss of clinical benefit
研究概览
简要总结
The primary objective of this study is to evaluate long-term effectiveness of adalimumab in pediatric participants starting a treatment for Crohn's disease in real life conditions, namely to describe the time to loss of clinical benefit in a time to event approach. Main secondary objectives are to describe growth and pubertal development and to describe long-term safety. The participants will be followed-up up to 10 years.
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
- •With confirmed diagnosis of Crohn's disease
- •Adalimumab-naïve patient (a patient having received an anti-TNF other than adalimumab may enter the study)
- •Starting a treatment with adalimumab
- •Guardian capable of and willing to grant authorization for use/disclosure of data collected and patient able to comply with the requirements of the study protocol.
排除标准
- •Participants with a history of treatment with adalimumab
- •Participants enrolled in a concomitant interventional clinical trial.
结局指标
主要结局
Time to loss of clinical benefit
时间窗: Up to 12 years
Loss of clinical benefit will be defined as one of the following: * Loss of efficacy leading to adalimumab discontinuation or * Introduction / reinforcement of other immunosuppressants (ratio dose/weight) or * Introduction / reinforcement of corticosteroids (ratio dose/weight; reinforcement of corticosteroids are allowed within the 4 first months after start of adalimumab) * Introduction of enteral nutrition * CD-related surgery, discontinuation of adalimumab due to adverse event, death.
次要结局
- Incidence rate of CD-related hospitalizations(Up to 12 years)
- Assessing Mucosal healing(Up to 12 years)
- Proportion of participants with fistula remission (in participants with fistulizing CD at entry)(Up to 12 years)
- Change in Tanner's staging(From Month 0 to 12 years)
- Proportion of participants with dose escalation (dose and/or frequency of injections)(Up to 12 years)
- Median percent change from baseline in C-reactive protein (CRP)(From Month 0 to 12 years)
- Rate of clinical remission(Up to 12 years)
- Median percent change from baseline in calprotectin(From Month 0 to 12 years)
- Change from baseline in weighted Pediatric Crohn's Disease Activity Index (PCDAI)(From Month 0 to 12 years)
- Proportion of participants achieving mucosal healing at each time point(Up to 12 years)
- Change in wPCDAI >= 37.5(From Month 0 to 12 years)
- Change in weight z-score(From Month 0 to 12 years)
- Proportion of participants with steroid-free clinical remission at each time point(Up to 12 years)
- Rate of steroid-free remission(Up to 12 years)
- Incidence rate of infectious events(Up to 12 years)
- Median percent change from baseline in high sensitivity C-reactive protein (hs-CRP)(From Month 0 to 12 years)
- Proportion of participants with immunomodulator-free clinical remission at each time point(Up to 12 years)
- Incidence rate of all-cause hospitalizations(Up to 12 years)
- Change in height z-score(From Month 0 to 12 years)
- Proportion of participants with CD-related surgery(Up to 12 years)
- Incidence rate of CD- or drug-related hospitalizations(Up to 12 years)
- Proportion of participants with steroid tapering at each time point (steroids daily dosing lower than at baseline)(Up to 12 years)