NL-OMON53012招募中4 期
An open-label interventional phase 4 study to evaluate efficacy , safety and mucosal healing of early versus late use of vedolizumab in Crohn's disease: the LOVE-CD study (LOw countries VEdolizumab in CD study) - LOVE-CD
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 130
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 64（—）
入选标准
- •- Moderately to severely active CD (Crohn disease activity index (CDAI)
- •220-450) with objective evidence of ulcerations visualized on endoscopy., -
- •Anti-TNF discontinued for at least 4 weeks prior to baseline, -Age 18 to 80, -
- •GROUP 1 (EARLY CD):, Diagnosis of CD < 24 months prior to enrollment ,
- •Demonstrated failure to respond to topical or systemic corticosteroids or
- •intolerance to corticosteroids,
- •and additionally, but not mandatory, lack of efficacy or intolerance to
- •thiopurines (azathioprine, 6-mercaptopurine or 6-thioguanine)(any duration).
- •Patients using thiopurines must have been using the agent for > 3 months (last
- •4 weeks at stable dose)., GROUP 2 (LATE CD), Demonstrated failure to respond to
- •at least 3 months of thiopurines or intolerance to thiopurines 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.
排除标准
- •- Prior treatment with vedolizumab, alpha4beta7 anti-bodies, beta7 antibodies
- •and anti MADCAM-1
- •- History of colonic dysplasia or colonic cancer
- •- Presence of stoma
- •- subjects with a pouch
- •- Received other biologics within the last 4 weeks of baseline
- •- subjects with ALT or AST 3x the upper limit of normal measured at screening
- •- Use of 5-ASA or corticosteroid enemas/suppositories within 2 weeks of
- •- Chronic hepatitis B or C infection
- •- Evidence of or treatment for C. difficile infection or other intestinal
- •pathogen at screening within 4 weeks prior to enrollment
- •- Active or latent tuberculosis
- •- Early CD group: previous exposure to any anti-TNF
研究者
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