Effectiveness and Safety of Ustekinumab Intensification in Crohn's Disease: a Retrospective Observational 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
- 1
- 主要终点
- Percentage of participants with steroid-free clinical remission at Week 24
研究概览
简要总结
The primary purpose of this study is to evaluate the efficacy and safety of intravenous administration at regular intervals of Ustekinumab in participants with loss of response to standard regimen or have evidence of high activity clinically, biochemically or endoscopically.
详细描述
This study evaluates the efficacy and safety of intravenous administration at regular intervals of Ustekinumab. It consists of escalation treatment period (Week 0 to 52); and safety follow up visit (24 weeks after last dose). Study assessments will include Harvey-Bradshaw index (HBI), Physician Global Assessment Score (PGA), laboratory evaluations, endoscopic evaluation, review of concomitant medications and adverse events (AEs).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Agree to participate in the study
- •With active Crohn's disease
- •Undergoing Ustekinumab dose intensification with at least two or more intravenous infusions at the discretion of the treating physician
- •HBI ≥ 5 before Ustekinumab therapy
- •Over 18 years of age
排除标准
- •Who had received Ustekinumab for an indication
- •Pregnant or nursing
- •History of enterectomy or enterostomy related to disease
- •Who used total enteral nutrition for more than 2 weeks due to complications such as obstruction, abscess and perforation after starting Ustekinumab therapy
- •Pregnant and lactating women
研究组 & 干预措施
intravenous maintenance at early stage
Participants who have evidence of high activity clinically, biochemically or endoscopically : HBI ≥8, inflammatory markers significantly increased (CRP > 5mg/L, fecal calprotectin> 200mg/g), SES-CD≥ 7, will get multiple intravenous injections of Ustekinumab maintenance after induction.
干预措施: Ustekinumab (Drug)
intravenous escalation when poor response
Participants who experience a loss of response or poor response to 90 mg Ustekinumab standard therapy will receive Ustekinumab intravenously at regular interval or at shorten interval.
干预措施: Ustekinumab (Drug)
结局指标
主要结局
Percentage of participants with steroid-free clinical remission at Week 24
时间窗: Week24
Percentage of participants with steroid-free clinical remission at Week 24 from the escalation will be assessed. Steroid-free clinical remission (performed only in patients on prednisone or budesonide at time of initiation of UST) was defined as tapering off steroids completely and HBI ≤ 4 points or complete resolution in CD symptoms or severity assessed by PGA.
次要结局
- Percentage of participants with endoscopic remission at Week 52(Week 52)
- Percentage of participants with normal fecal calprotectin level at Week 52(Week 52)
- Percentage of Participants with Infections and Serious Infections(up to 1.5 years)
- Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)(up to 1.5 years)
- Percentage of participants with biochemical remission at Week 24(Week 24)
- Percentage of Participants continue UST(up to 1.5 years)