EUCTR2014-005376-29-BE
进行中（未招募）
1 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
Academic Medical Center, Gastroenterology0 个研究点目标入组 260 人2015年2月3日
相关药物Entyvio
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Active Crohn's disease
- 发起方
- Academic Medical Center, Gastroenterology
- 入组人数
- 260
- 状态
- 进行中（未招募）
- 最后更新
- 9年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •\- Established diagnosis of ileal, ileocolonic or colonic Crohn’s disease with histopathological confirmation available in the record of the patient.
- •\- Moderately to severely active CD (CDAI 220\-450\) with objective evidence of ulcerations visualized on endoscopy.
- •\- Anti\-TNF discontinued for at least 6 weeks
- •\-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
- •or: need for \> 2 courses of steroids since diagnosis
- •or: steroid dependency at any dose since diagnosis
- •GROUP 2 (LATE CD)
排除标准
- •\- Prior treatment with vedolizumab.
- •\- Contraindication for endoscopy.
- •\- History of colonic dysplasia/cancer
- •\- Presence of stoma
- •\- Received other biologics within the last 6 weeks of screening
- •\- use of 5\-ASA or corticosteroid enemas/suppositories within 2 weeks of enrollment
- •\- 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
- •\- Conditions which in the opinion of the investigator may interfere with the subject’s ability to comply with the study procedures.
结局指标
主要结局
未指定
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