Efficacy of Guselkumab in Chinese Participants With Crohn's Disease Following Loss of Response to Ustekinumab
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 78
- 试验地点
- 5
- 主要终点
- Percentage of Participants Achieving Clinical Remission At Week 48
研究概览
简要总结
The purpose of this study is to evaluate how well guselkumab works in participants with Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract) who no longer respond to treatment with ustekinumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 Crohn's disease (CD)
- •Diagnosed with active CD, as defined by baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (>=) 220
- •Participants had received the ustekinumab (UST) induction phase and received maintenance therapy via subcutaneous (SC) injection every 8 weeks or every 12 weeks
- •Initially responded to UST induction therapy and then lose response to UST
- •During the screening period, participants are receiving UST treatment as the first line biologic or second line biologic
排除标准
- •Received UST dose optimization or multiple intravenous therapy in maintenance phase
- •Participants with CD requiring urgent surgical or endoscopic intervention, or requiring elective surgery within 2 months
- •Is currently enrolled in an interventional clinical study
- •Complications of CD, such as symptomatic strictures or stenoses, short gut syndrome
- •Have a current or be suspected to have an abscess
研究组 & 干预措施
Guselkumab Treatment
Participants will receive Guselkumab intravenously (IV) every 4 weeks during the induction phase, followed by subcutaneous (SC) administration of Guselkumab every 4 weeks from Week 12 through Week 44 as maintenance therapy.
干预措施: Guselkumab (GUS) (Drug)
结局指标
主要结局
Percentage of Participants Achieving Clinical Remission At Week 48
时间窗: At Week 48
Clinical remission is defined as less than (\<) 150-point reduction in Crohn's Disease Activity Index (CDAI) score. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. The CDAI score was assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities.
次要结局
- Percentage of Participants Achieving Clinical Response At Weeks 12, 24 and 48(At Weeks 12, 24 and 48)
- Percentage of Participants Achieving Clinical Remission At Weeks 12 and 24(At Weeks 12 and 24)
- Percentage of Participants Achieving Endoscopic Response(At Weeks 24 and 48)
- Percentage of Participants Achieving Endoscopic Remission(At Weeks 24 and 48)
- Baseline Characteristics of Participants With Endoscopic Remission: Age(Baseline)
- Baseline Characteristics of Participants With Endoscopic Remission: Sex(Baseline)
- Baseline Characteristics of Participants With Endoscopic Remission: Height(Baseline)
- Baseline Characteristics of Participants With Endoscopic Remission: Weight(Baseline)
- Baseline Characteristics of Participants With Endoscopic Remission: History of Advanced Treatment, Concomitant Medications(Baseline)
- Baseline Characteristics of Participants With Endoscopic Remission: Comorbidities(Baseline)
- Baseline Characteristics of Participants With Endoscopic Remission: Surgeries and Procedures(Baseline)