Synergistic Effect of Vedolizumab and Pentoxifylline in the Management of Patients With Inflammatory Bowel Disease
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- proportion of patients in clinical remission
研究概览
简要总结
The purpose of this study is to determine the synergistic effect and clinical benefits of vedolizumab and pentoxifylline in the management of patients with inflammatory bowel disease.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients with active Crohn's disease (CD) defined by blood lab values, stool markers, abnormal MR enterography imaging, or colonoscopic findings
- •Patients who are good candidates to start standard dosing of vedolizumab
- •Patients who have not used an off-label or investigational drug for CD in the 8 weeks prior to screening
- •Patients who have met the washout period of 8 weeks for infliximab, 4 weeks for certolizumab pegol, and 2 weeks for adalimumab if there is a history of anti-TNF exposure and 8 weeks if there is a history of exposure to natalizumab
- •Oral aminosalicylates are allowed during the study, provided that the dose has been stable for at least 2 weeks prior to screening
- •Oral corticosteroids are allowed provided that the dose is prednisone ≤40 mg/day or equivalent and/or budesonide ≤9mg/day and has been stable for at least 2 weeks prior to screening
- •Patients are able to discontinue thiopurines (azathioprine and 6-mercaptopurine) or methotrexate upon initiation of vedolizumab
- •Rectal therapies, narcotics, anti-diarrheals, probiotics, and antibiotics will be permitted at investigator discretion
排除标准
- •Contraindications or history of allergy to PTX
- •Known interaction of PTX with patient's current medications
- •Use of an off-label or investigational drug for CD in the 8 weeks prior to first VDZ infusion
- •Pregnancy
- •GFR <30 at any time in the 6 months prior to first infusion of VDZ
- •Documented cirrhosis
- •Age <18 or >80 years old
- •Contraindication to colonoscopy at 24 week study time-point
研究组 & 干预措施
vedolizumab plus pentoxifylline
Patients will receive standard induction and maintenance dosing of vedolizumab 300 mg intravenously as well as pentoxifylline 400 mg orally thrice daily.
干预措施: vedolizumab (Drug)
vedolizumab plus pentoxifylline
Patients will receive standard induction and maintenance dosing of vedolizumab 300 mg intravenously as well as pentoxifylline 400 mg orally thrice daily.
干预措施: Pentoxifylline (Drug)
vedolizumab plus placebo
Patients will receive standard induction and maintenance dosing of vedolizumab 300 mg intravenously as well as placebo orally thrice daily.
干预措施: vedolizumab (Drug)
vedolizumab plus placebo
Patients will receive standard induction and maintenance dosing of vedolizumab 300 mg intravenously as well as placebo orally thrice daily.
干预措施: placebo (Drug)
结局指标
主要结局
proportion of patients in clinical remission
时间窗: week 14
次要结局
- number of new major and minor infections(week 24)
- number of episodes of hepatotoxicity(week 24)
- number of episodes of myelosuppression(week 24)
- number of episodes of nephrotoxicity(week 24)
研究者
Amar Deshpande
Associate Professor
University of Miami