NCT02770040已完成4 期
PREDICT UC: Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Clinical response by day 7
研究概览
简要总结
The purpose of this study is to identify whether an Accelerated or Intensified Infliximab induction regimen is superior to Standard induction in Acute Severe Ulcerative Colitis in an open label multi-centre randomised controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years old
- •Diagnosis of Ulcerative Colitis
- •Acute Severe Colitis according to the Truelove and Witt's Criteria
- •Steroid refractory according to the Oxford Criteria
排除标准
- •Participant unable to consent for themselves
- •Indication for immediate surgery (acute abdomen, perforation of the bowel, haemorrhage)
- •Crohn's disease
- •Participants with enteric infection confirmed on stool microscopy, culture or toxin
- •Haemodynamic instability (mean arterial pressure <60) and not responsive to fluids
- •Participants with clinically significant Cytomegalovirus infection (positive inclusion bodies, immunohistochemistry and signs of viraemia such as fever and abnormal liver function tests)
- •Participants who are pregnant or currently breast-feeding
- •Participants with current malignancy, excluding basal cell carcinoma
- •Participants with flat low or high grade colonic dysplasia; sporadic adenomas permitted
- •Participants with serious co-morbidities including: Immunodeficiency; Myocardial infarction or acute stroke within the last 3 months; Moderate or severe heart failure (New York Heart Association class III or IV); Active or suspected tuberculosis; Renal failure; Hepatic failure; other severe infections
- •Participants with history of hypersensitivity to infliximab or infliximab biosimilar
- •Participants who have received other immunosuppressive agents including but not limited to: Anti-TNF therapies within 3 months of screening (Infliximab, Infliximab biosimilar, Golimumab, Etanercept, Certolizumab or Adalimumab); Anti-integrins (Vedolizumb, Etrolizumab) within 4 months of screening; Calcineurin inhibitors (Cyclosporine, Tacrolimus) within 4 weeks of screening; T or B cell depleters (Rituximab, Alemtuzumab) within 12 months of screening; other investigational agents (eg. Ustekinumab) within 6 months of screening
研究组 & 干预措施
Intensified Infliximab Induction
Active Comparator
Infliximab 10mg/kg at Week 0 and Week 1
干预措施: Infliximab (Drug)
Accelerated Infliximab Induction
Active Comparator
Infliximab 5mg/kg at Week 0, Week 1 and Week 3
干预措施: Infliximab (Drug)
Standard Infliximab Induction
Active Comparator
Infliximab 5mg/kg at Week 0, Week 2 and Week 6
干预措施: Infliximab (Drug)
结局指标
主要结局
Clinical response by day 7
时间窗: Day 7
Defined as a reduction in the Lichtiger score below 10 with a decrease of at least 3 points and an improvement in rectal bleeding and stool frequency to ≤4 per day
次要结局
- Colectomy by Day 7(From Day 0 to Day 7)
- Time to clinical response(Up to 3 months)
研究者
Dr Peter De Cruz
Head of Inflammatory Bowel Disease Unit
Austin Health
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A Study to Evaluate Efficacy and Safety of Infliximab in Participant With Moderate-to-Severe Refractory Intestinal Behcet's DiseaseBehcet DiseaseNCT02505568Janssen Korea, Ltd., Korea33
Unknown
3 期
Efficacy and Safety of Two Regimens of Maintenance Therapy in Children With Crohn DiseaseCrohn DiseaseNCT01559142Children's Memorial Health Institute, Poland100
已完成
3 期
A Study to Evaluate Safety and Efficacy of Infliximab in Chinese Participants With Moderate to Severe Plaque-type PsoriasisPsoriasisNCT01177800Xian-Janssen Pharmaceutical Ltd.129
Unknown
不适用
Individualized Infiximab Dosing-Proof of Concept StudyInflammatory Bowel DiseasesNCT02027727Cedars-Sinai Medical Center56
已完成
4 期
Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease (IBD)Crohn's DiseaseUlcerative ColitisNCT01346826Asan Medical Center145