CTIS2023-508391-11-00进行中（未招募）1 期
Investigating the safety, feasibility, and optimal dose of fluorescently labeled Adalimumab-680LT for visualizing drug targeting in Inflammatory Bowel Diseases. - 18146
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
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 65+（—）
- 性别
- All
入选标准
- •Established IBD diagnosis (UC or CD), Active disease: clinically active disease of the bowel is defined clinically as at least mild activity using dedicated scoring indices and biochemically active disease as defined by a fecal calprotectin > 60 µg/g (measurement within the last 6 weeks before inclusion, Patients must be eligible for adalimumab therapy, Age of 18 years, Written informed consent., Clinical indication for an endoscopic procedure
排除标准
- •A female study patient who is pregnant or provides breastfeeding will be excluded from participation in this study, Medical or psychiatric conditions that compromise the patient’s ability to give informed consent, Prior anti-TNF therapy in the last 6 weeks before inclusion, A female study patient of premenopausal age who does not use any reliable form of contraception at the time of adalimumab-680LT administration and the following 10 weeks, Active extra gastrointestinal manifestations of Crohn’s disease (e.g. uveitis or pyoderma gangrenosum at vital locations), Previous treatment with adalimumab and detectable anti-adalimumab antibodies levels
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