KCT0006087撤回未知
Efficacy and Safety of vedolizumab in biologic-naïve Korean patients with moderate to severe inflammatory bowel disease
适应症
试验速览
- 阶段
- 未知
- 状态
- 撤回
- 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 Study
入排标准
- 年龄范围
- 19?(Year) 至 70?(Year)（—）
- 性别
- All
入选标准
- •1) Adults aged = 19 years to = 70 years
- •2) Patients with moderate-to-severe active Crohn's disease or ulcerative colitis who are unresponsive to, become unresponsive to, or have no tolerability to universal treatment (with corticosteroids, immunomodulators, etc.)
- •- CDAI (Crohn’s Disease Activity Index) = 220 for Crohn's disease
- •- Complete Mayo score = 6 for ulcerative colitis
排除标准
- •1) A history of total colectomy
- •2) Acute severe UC
- •3) A potential for a bowel resection surgery within 3 months
- •4) Pregnancy and breastfeeding
- •5) Prior use of any biologics including anti-TNFs, ustekinumab, and tofacitinib.
- •6) A history of solid cancer and blood cancer within 5 years
- •7) Positive for active or latent tuberculosis (However, screening is possible if active tuberculosis is excluded and after at least 4 weeks of latent tuberculosis treatment.)
- •8) Active severe infections such as sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as progressive multifocal leukoencephalopathy (PML).
- •9) Hypersensitivity to vedolizumab or its substances (e.g., dyspnoea, bronchospasm, redness, and increased heart rate)
- •10) Experience of treatment with a drug or a medical device due to participation in another clinical trial within 3 months from the date of consent
- •11) A woman of childbearing potential who has a positive pregnancy test (Urine-hCG or Serum hCG) at a screening visit or does not agree to use at least one of medically acceptable, effective contraceptive methods*. However, females who reached menopause at least one year ago or turned out infertile due to an operation should be excluded.
- •*Effective contraceptive methods: intrauterine devices (e.g., IUD, mirena), dual barrier methods (diaphragm or condom/femidom + spermicide), and parenteral contraceptives. Continuing only sexual abstinence is not viewed as an acceptable method.
- •12) A woman of childbearing potential who neither practices adequate contraception nor agrees to continue its use for at least 18 weeks after the last dose of the study drug.
- •13) Those decided by the investigator to be not eligible for this study
研究者
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