Second-line Advanced Therapy in Crohn's Disease: Real-life Effectiveness and Resolution of First-line Suboptimal Control Indicators (CROHNOS - CROHN Therapy Observational Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 41
- 主要终点
- Percentage of Participants who Achieve Corticosteroids (CS) Free Remission
研究概览
简要总结
Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will evaluate the second line effectiveness of upadacitinib and risankizumab in Crohn's Disease (CD) in a real-world setting.
Upadacitinib and risankizumab are approved drugs for treating CD. Approximately 250 participants who are prescribed upadacitinib or risankizumab by their physician in accordance with local label will be enrolled in 25 sites across Italy.
Participants will receive upadacitinib or risankizumab as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 18 months.
No additional burden for participants in this trial is expected.
详细描述
The retrospective phase will be up to 2 years prior to enrollment to the study, the prospective phase will be up to 18 months after enrollment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with a diagnosis of moderate-to-severe Crohn's Disease (CD) confirmed by clinical, and/or endoscopic/histological indexes
- •Participants previously treated with Tumor Necrosis Factor inhibitor (TNF-i) as fist line (1L) therapy for at least 6 months; clinical documentation available in medical charts for the previous 2 years or since the beginning of the 1L therapy
排除标准
- •Any condition included in the "warning and precautions" and "contraindications" section of the approved local upadacitinib/risankizumab label
- •Participants previously exposed to upadacitinib/risankizumab or any approved or investigational non TNFi biologic Disease Modifying Antirheumatic Drug (bDMARDs) for CD
研究组 & 干预措施
Upadacitinib
Participants with Crohn's Disease prescribed upadacitinib in routine clinical practice are observed from the first dose up to 18 months.
Risankizumab
Participants with Crohn's Disease prescribed risankizumab in routine clinical practice are observed from the first dose up to 18 months.
结局指标
主要结局
Percentage of Participants who Achieve Corticosteroids (CS) Free Remission
时间窗: Month 12
CS free remission is defined as clinical remission with Harvey Bradshaw Index (HBI) \<4 and absence of corticosteroid use since at least three months prior to month 12.
次要结局
未报告次要终点