CTIS2023-505317-25-00招募中1 期
FAPi-PET imaging of in vivo early fistula healing in perianal Crohn’s disease: PERSIST study - NL53558.018.22
Amsterdam UMC0 个研究点目标入组 10 人开始时间: 2023年4月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
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（—）
- 性别
- All
入选标准
- •1.Confirmed diagnosis of CD with previously or currently documented luminal inflammation (endoscopy and histopathology), 2.Complex perianal fistula, defined as either involving the upper two-third of the sphincter complex (i.e., high intersphincteric, high transsphincteric, suprasphincteric or extrasphincteric course of the fistula tract), having multiple external openings, are associated with pain or fluctuation suggesting a perianal abscess or are associated with a rectovaginal fistula or anorectal stricture or active rectal ulcers, with active drainage (fluid loss on gentle compression; perianal fistulas that were previously close but that reopened can be included)., 3.Age 16 or older, 4.Signed informed consent
排除标准
- •1.Patients with Ulcerative Colitis or IBD-U 2.Presence of impassible anal stricture 3.Superficial or rectovaginal fistula only 4.Patients with ongoing abdominal or undrained perianal abscesses after repeated examination-under-anesthesia with drainage by incision or seton placement 5.Patients with a seton in situ > 12 months 6.Patients with an ostomy 7.Enteric pathogens (such as Salmonella, Shigella, Yersinia, Campylobacter and C. difficile) detected by stool analysis within 2 weeks prior to enrollment or at screening 8.Active or planned pregnancy or lactation Patients previously exposed to two or more anti-TNFs 9.Previously unacceptable side effects or intolerance to all immunosuppressants (both thiopurines and methotrexate) Treatment with vedolizumab or ustekinumab within 30 days 10.Active or latent tuberculosis (screening according to national guidelines) 11.Cardiac failure in NYHA stage III-IV 12.History of demyelinating disease 13.Recent live vaccination (= 4 weeks) 14.Patients with ongoing acute/chronic infection (including but not limited to HIV, hepatitis B and C) with the exception of chronic herpes labialis or cervical HPV 15.Male patients with negative EBV serology 16.Patients who received any investigational drug in the past 30 days or 5 half-lives, whichever is longer 17.Patients with a history of colon cancer or colonic dysplasia, unless sporadic adenoma, which has been removed 18.A history of alcohol or illicit drug use that in the opinion of the principal investigator (PI) would interfere with study procedures 19.Patients with psychiatric problems that in the opinion of the PI would interfere with study procedures 20.Patients unable to attend all study visits 21.Participation in a medical intervention trial that interferes with this study in the opinion of the PI 22.Patients with a history of non-compliance with clinical study protocols
研究者
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