A Prospective, Real-World Study EvalUating the EffectiveNess and Safety of RISankizumab in PatiEnts With Ulcerative Colitis (SUNRISE-UC)
概览
- 阶段
- 不适用
- 干预措施
- Risankizumab
- 疾病 / 适应症
- Ulcerative Colitis
- 发起方
- AbbVie
- 入组人数
- 200
- 试验地点
- 96
- 主要终点
- Percentage of Participants Achieving Symptomatic Remission Responder Per Partial Adapted Mayo Score
- 状态
- 招募中
- 最后更新
- 2个月前
概览
简要总结
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess the change in disease activity of risankizumab treatment in adult participants with moderate to severe UC in real-world clinical practice.
Risankizumab is an approved drug for treating participants with ulcerative colitis. Approximately 200 participants who are prescribed risankizumab by their physician in accordance with local label will be enrolled in approximately multiple sites across Germany and Austria.
Participants will receive risankizumab as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 52 weeks.
There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.
研究者
入排标准
入选标准
- •Participants with an endoscopically confirmed diagnosis of moderate to severe ulcerative colitis.
- •Participants initiating risankizumab at the investigator's discretion as part of their routine clinical care; the decision to administer risankizumab must be made prior to and independent of documentation for the study and according to the approved local label.
排除标准
- •Participants previously exposed risankizumab
- •Participants who are currently participating in interventional research (not including noninterventional studies, post-marketing observational study (PMOS), or registry participation).
研究组 & 干预措施
Risankizumab
Participants will receive risankizumab as prescribed by their physician according to local label.
结局指标
主要结局
Percentage of Participants Achieving Symptomatic Remission Responder Per Partial Adapted Mayo Score
时间窗: Up to approximately 52 weeks
Symptomatic remission is defined as stool frequency (SFS) \<=1 and rectal bleeding subscore (RBS)=0