NCT04006080Unknown4 期
Investigation of the Faecal Loss of Vedolizumab and Its Role in Influencing Serum Drug Levels, Outcomes and Response in Ulcerative Colitis
适应症
干预措施
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in vedolizumab concentrations in stool
研究概览
简要总结
The purpose of this study is to study the loss of vedolizumab in stool in patients with active ulcerative colitis (UC).
Patients with moderate-to-severe UC who are commencing induction therapy with vedolizumab will be enrolled into a prospective study and stool will be collected for faecal vedolizumab measurement at days 1, 4 and 7; and again at weeks 2, 6 and 14. They will also be evaluated at three time-points (weeks 2, 6 and 14) for clinical and biochemical UC disease activity as well as serum vedolizumab concentrations and anti-vedolizumab antibodies.
详细描述
Primary objective
- To determine whether vedolizumab is present in significant quantities in the stool of patients receiving induction therapy with vedolizumab for active UC.
Secondary objective (s)
- To evaluate whether the presence and quantity of vedolizumab in stool can be used to predict primary non-response to vedolizumab.
- To explore whether a correlation exists between stool vedolizumab concentrations, serum vedolizumab concentrations and UC disease activity and extent.
- To determine whether there is a correlation between stool and serum vedolizumab levels and trafficking of Th1/Th17 effector memory CD4+ T-cells (the key pathogenic subset in IBD) to the colon in UC.
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
- •Aged 18 years or over, either male or female
- •Moderate-to-severe UC, defined as:
- •SCCAI > 5 and, i. A raised fecal calprotectin (> 59 μg/g) or, ii. A raised CRP (> 5 mg/L) or, iii. Endoscopic disease activity Mayo 2 or above, Evaluated within 6 weeks of study enrollment
- •Commencing vedolizumab treatment
- •Sufficient English language skills to understand the patient information sheet and consent form
排除标准
- •Contra-indication to vedolizumab (i.e. known serious or severe hypersensitivity reaction to vedolizumab or any of its excipients)
- •Imminent need for colectomy (i.e. colectomy is being planned)
- •Previous ileoanal pouch formation
- •Active severe infections such as tuberculosis, sepsis, cytomegalovirus, listeriosis, and opportunistic infections
研究组 & 干预措施
Vedolizumab
Experimental
干预措施: Vedolizumab (Biological)
结局指标
主要结局
Change in vedolizumab concentrations in stool
时间窗: Days 1, 4 and 7; and weeks 2, 6 and 14
Evaluated using an enzyme-linked immunosorbent assay (ELISA)
次要结局
- Vedolizumab serum concentrations(Weeks 2, 6 and 14)
- Serum CRP (mg/L)(Day 0, weeks 2, 6 and 14)
- UC histological activity(Day 0 and week 14)
- Faecal calprotectin(Day 0, weeks 2, 6 and 14)
- Quality of life questionnaire(Day 0, weeks 2, 6 and 14)
- Vedolizumab anti-drug antibody levels(Weeks 2, 6 and 14)
- Serum albumin (g/L) [40-52g/L](Day 0, weeks 2, 6 and 14)
- UC endoscopic activity(Baseline and week 14)
- Clinical UC disease activity(Day 0, weeks 2, 6 and 14)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
Investigation of the Faecal loss of Vedolizumab and its role in influencing serum drug levels, Outcomes and Response in ulcerative colitislcerative colitis (UC)MedDRA version: 20.0 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disordersEUCTR2018-002794-21-GBGuy's & St Thomas NHS Foundation Trust30
Unknown
不适用
Measuring Endoscopic ACTIvity in Patients Treated With VEDOlizumab for Ulcerative ColitisUlcerative ColitisNCT03839680Centre Hospitalier Universitaire de Besancon60
已完成
不适用
A Study in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) Receiving Vedolizumab in Real-World Practice in SwitzerlandInflammatory Bowel DiseasesCrohns DiseaseColitis, UlcerativeNCT04989907Takeda92
招募中
3 期
A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)Crohn's Disease (CD)NCT04779320Takeda120
已完成
3 期
A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis (UC)Colitis, UlcerativeNCT04779307Takeda120