Guselkumab Real-world Effectiveness Among Bio-NaÏve Patients With Moderate-to-severe Ulcerative Colitis in China: A Multicenter, Non-interventional, Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 10
- 主要终点
- Percentage of Participants Achieving Clinical Response at Week 12
研究概览
简要总结
The purpose of this study is to assess the measurable changes in health, function, or quality of life (clinical outcomes) after receiving guselkumab in real-world clinical practice amongst Chinese participants with ulcerative colitis (UC; a long-term disease of the large intestine in which the lining of the colon [part of large intestine] becomes inflamed and develops tiny open ulcers), who have not received biologic therapy (a medicine made from living organisms or their components) previously.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a confirmed diagnosis of moderately to severely active UC, defined as: a) baseline modified Mayo score of 4 to 9; b) screening endoscopy with Mayo endoscopic subscore (MES) greater than or equal to (>=) 2; c) Mayo rectal bleeding subscore (RBS) >= 1 at baseline
- •Eligible for advanced treatment and initiate guselkumab therapy per participating physician decision in accordance with product package insert
- •Have no prior exposure to advanced therapies (bio-naive), such as tumor necrosis factor (TNF)-alpha antagonists, anti-integrin agents, anti-interleukin (IL) agents, sphingosine-1-phosphate receptor modulators, janus kinase (JAK) inhibitors or their corresponding generics and biosimilars, per participating physician assessment
- •Participant (and/or their legally-acceptable representative where applicable) must sign an informed consent form (ICF) allowing source data verification in accordance with local requirements
排除标准
- •Acute severe UC or infectious colitis or other conditions when patients is likely to require a colectomy
- •Contraindicated to guselkumab per the label
- •Currently enrolled in or plan to participate in any other clinical trials from signing informed consent to the final dose administration of guselkumab
- •Participants who will be receiving guselkumab therapy combined with a second advanced therapy
- •Participants with a history of colectomy and/or pouch
研究组 & 干预措施
Guselkumab: Moderate to Severe Ulcerative Colitis (UC)
Participants with confirmed diagnosis of moderate-to-severe UC treated with guselkumab as per standard clinical practice will be enrolled. No drug will be provided as part of this study. Only data available from standard clinical practice and medical records will be collected and observed.
结局指标
主要结局
Percentage of Participants Achieving Clinical Response at Week 12
时间窗: At Week 12
Clinical response is defined as a decrease from baseline in the partial Mayo score by \>= 30 percent (%) and \>= 2 points, with either a \>=1 decrease from baseline in rectal bleeding subscore (RBS) or an RBS of 0 or 1. Partial Mayo score is a non-invasive clinical measure for determining the severity of UC. The total score falls between 0 and 9, where higher score indicates more severity.
次要结局
- Percentage of Participants Achieving Clinical Response at Week 24 and Week 48(At Week 24 and Week 48)
- Percentage of Participants Achieving Symptomatic Response at Week 2(At Week 2)
- Mean Change from Baseline in Stool Frequency Subscore (SFS) Over Week 2(From Baseline to Week 2)
- Mean Change from Baseline in RBS Over Week 2(From Baseline to Week 2)
- Percentage of Participants Achieving Clinical Remission at Week 12, Week 24 and Week 48(At Week 12, Week 24 and Week 48)
- Percentage of Participants Achieving Symptomatic Remission at Week 2(At Week 2)
- Percentage of Participants Achieving Steroid-Free Remission at Week 12, 24 and 48(At Weeks 12, 24 and 48)
- Percentage of Participants Achieving Sustained Remission at Week 24 and Week 48(At Week 24 and Week 48)
- Percentage of Participants with Endoscopic Improvement (Healing) at Week 24 and Week 48(At Week 24 and Week 48)
- Percentage of Participants Achieving Endoscopic Remission (Normalization) at Week 24 and Week 48(At Week 24 and Week 48)
- Percentage of Participants Discontinuing from Treatment(Up to Week 48)
- Percentage of Participants Switching from Treatment(Up to Week 48)
- Time to Treatment Discontinuation(Up to Week 48)
- Time to Treatment Switch(Up to Week 48)
- Percentage of Participants on Guselkumab Dosing Schedules of 200 Milligrams (mg) Once Every 4 Weeks (q4w) or 100 mg Once Every 8 Weeks (q8w)(From Baseline through Week 12 to Week 48)
- Percentage of Participants Undergoing Dose Escalation/ De-Escalation(Week 12 up to Week 48)
- Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission(At Week 12, Week 24 and Week 48)
- Change from Baseline in C-Reactive Protein (CRP) Levels(Baseline, Week 12, Week 24 and Week 48)
- Change from Baseline of Fecal Calprotectin Levels(Baseline, Week 12, Week 24 and Week 48)
- Percentage of Participants Achieving CRP Normalization(At Week 12, Week 24 and Week 48)
- Percentage of Participants Achieving Fecal Calprotectin (FCP) Normalization(At Week 12, Week 24 and Week 48)