Effectiveness of Vedolizumab Therapy in Inducing Clinical Remission in CD Patients Naïve to Anti-TNF and Its Capability to Halt Disease Progression
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Harvey Bradshaw index
研究概览
简要总结
Anti-cytokine antibodies, such as Infliximab (an anti TNF alfa chimeric antibody) and Adalimumab (an anti TNF alfa humanize antibody), have been developed and used in clinical practice for the treatment of patients with Crohn disease (CD). Unfortunately, their efficacy is limited. Based on these concepts, a new drug has been developed for IBD treatment. Vedolizumab (VDZ) is able to recognize the α4β7 heterodimer, and selectively blocks gut lymphocyte trafficking.
The hypothesis of this study is that VDZ therapy may be to halt CD disease progression during time and modifying its natural history, using Lemann Index.
详细描述
All patients who will enter in the study will be follow-up at weeks 2-6-14-22-30-38-46 or before in case of relapse. A relapse will be defined by an Harvey Bradshaw Index ≥ 5 for 2 consecutive weeks. The following data are to be recorded:
- Physical examination
- Adverse Event Review
- Weight in Kg
- Full blood count
- Biochemical series including serum iron, serum ferritin, C reactive protein (PCR), ESR (eritrosedimatation rate)
- Fecal Calprotectin
- VDZ fecal loos
- VDZ trough levels and antidrug antibodies
- Current treatments
The last visit will be performed at week 54. The following data are to be recorded:
- Physical examination
- Adverse Event Review
- Weight in Kg
- Full blood count
- Biochemical series including serum iron, serum ferritin, C reactive protein (PCR), ESR (eritrosedimatation rate)
- Fecal Calprotectin
- VDZ fecal loos
- VDZ trough levels and antidrug antibodies
- Current treatments
- Routine lower and upper gastrointestinal endoscopy and magnetic resonance imaging or computed tomography of the small bowel
- SES-CD
- Lemann Index
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have given written informed consent to participate
- •Be aged between 18 and 80
- •Have a moderate/severe CD defined by an HBI >7 CD
排除标准
- •previous treatment with anti-TNF drugs,
- •concomitant use of immune-modulator drugs for CD (azathioprine/6-mercaptopurine, methotrexate)
- •ulcerative colitis (UC) or inflammatory bowel disease undetermined (IBD-U) diagnosis
- •symptomatic obstructive disease
- •bowel resection within the past 6 months
- •ileostomy
- •extensive small bowel resection (as determined by the investigator) or a short bowel syndrome
- •patients who are currently receiving total parenteral nutrition
- •history of cancer in the past 5 years
- •pregnancy known at the study inclusion
- •positive Clostridium difficile stool assay
- •Listeria, human immunodeficiency virus, central nervous system demyelinating disease, untreated tuberculosis
研究组 & 干预措施
single arm study
Vedolizumab 300 mg iv at week 0, week 2 and week 6, than every 8 weeks.
干预措施: vedolizumab (Drug)
结局指标
主要结局
Harvey Bradshaw index
时间窗: Week 0-14
Primary responders will defined as by a decrease of Harvey Bradshaw Index at week 14 of 3 point from the Harvey Bradshaw Index calculate at week 0.
次要结局
- VDZ trough levels(Week 0-2-6-14-22-30-38-46-54)
- Lèmann Index(Week 0 and Week 54)
- anti-drug antibodies(Week 0-2-6-14-22-30-38-46-54)
- fecal VDZ loss(Week 0-2-6-14-22-30-38-46-54)
研究者
Giorgia Bodini
MD, PhD
Universita degli Studi di Genova