NL-OMON47577已完成4 期
An open label interventional phase 4 study to Evaluate Efficacy, Safety and Mucosal Healing of early versus late use of vedolizumab in ulcerative colitis: the LOVE-UC study (LOw countries VEdolizumab in UC study) - LOVE-UC
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Age 18 to 80
- •2. Established diagnosis of ulcerative colitis with histopathological confirmation available in the record of the patient.
- •3. Moderate to severe active UC (total Mayo score > 6) with objective evidence of inflammation that can be visualized on endoscopy. Patients must have an endoscopic Mayo score of 2 or 3.
- •4. Anti-TNF discontinued for at least 4 weeks before baseline;GROUP 1 (EARLY UC)
- •1. Diagnosis of UC < 4 years prior to enrollment confirmed by clinical, endoscopic and histopathological evidence.
- •2. Demonstrated failure to respond to aminosalicylates or intolerance to aminoslicylates
- •and: failure to respond to topical or systemic corticosteroids or intolerance to corticosteroids
- •or: need for 1 course of steroids since diagnosis
- •and additionally, but not mandatory, lack of efficacy of thiopurines or intolerance to thiopurines (any duration). Patients who are using thiopurines (azathioprine, 6-mercaptopurine or 6-thioguanine) at screening must have used them for > 3 months (last 4 weeks at stable dose).;GROUP 2 (LATE UC);1. Diagnosis of UC > 4 years confirmed by clinical, endoscopic and histopathological evidence.
- •2. Demonstrated failure to respond to aminosalicylates or intolerance to aminosalicylates
- •and: failure to respond to at least 3 months of thiopurines or intolerance to TP
- •and: failure to respond to at least 1 anti-TNF or intolerance to anti-TNF or loss of response to at least 1 anti-TNF. Loss of response to anti-TNF is defined as recurrence of symptoms during maintenance dosing following prior clinical benefit.
排除标准
- •1. Prior treatment with vedolizumab; a4β7 anti-bodies ; β7 antibodies ; anti- MADCAM-1 .
- •2. History of colonic dysplasia or colonic cancer.
- •3. Extensive colonic resection, i.e. subtotal or total colectomy with <15 cm colon remaining
- •4. Received other biologics within the last 4 weeks of baseline
- •5. Use of 5-ASA or corticosteroid enemas/suppositories within 2 weeks of enrollment
- •6. Chronic hepatitis B or C infection
- •7. Evidence of or treatment for C. difficile infection or other intestinal pathogen at screening within 4 weeks prior to enrollment
- •8. Active or latent tuberculosis
研究者
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