NCT01275508已完成1 期
Prospective, Monocentric, Open-label, Clinical Phase 1 Study to Demonstrate the Safety and Tolerability of FITC-Adalimumab After Single Topical Administration to the Intestinal Mucosa During Endomicroscopy in Patients With Crohn's Disease
University of Erlangen-Nürnberg Medical School1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2011年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Safety and tolerability of Fluoresceinisothiocyanate (FITC)-Adalimumab
研究概览
简要总结
The scientific objective of the project is to evaluate if the topical administration of Fluoresceinisothiocyanate (FITC)-Adalimumab during the endomicroscopic examination of the gut in Crohn's disease (CD) patients shows an acceptable safety profile. Another objective is to explore whether the use of FITC-Adalimumab as a predictive biomarker might reliably predict patient response to Adalimumab therapy and hence enable optimized utilization of this treatment option.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Trial subjects must meet all of the following inclusion criteria:
- •Male and female subjects from 18 to 70 years of age who are capable of giving informed consent without any restrictions
- •Endoscopically and histologically confirmed diagnosis of Crohn's disease (CD)
- •Manifestation of CD in the colon and/or in the terminal ileum
- •Currently active CD with a CDAI score >150
- •Clinically inadequate response of CD to systemic glucocorticoids and/or immunosuppressants (azathioprine, 6-mercaptopurine, methotrexate) or glucocorticoid-dependent CD or any contraindication to glucocorticoids
- •Indication for treatment with Adalimumab
- •Indication for intestinal confocal laser endomicroscopy prior to institution of adalimumab therapy
- •Subject is mentally capable of understanding the nature and purpose/conduct of the clinical trial and of following the study staff's instructions
- •Subject has given written informed consent after being informed by an investigator
- •Female subjects additionally must meet at least one of the following criteria:
- •Must be menopausal (at least 12 months' natural amenorrhea or 6 months' amenorrhea with serum FSH >40 mU/mL) or
- •Must have undergone bilateral oophorectomy or hysterectomy or
- •Must be a regular, correct, and reliable user of a contraceptive method with a failure rate of <1% per year (such as oral contraceptives, implants, depot shots, intrauterine device, hormone coil)
- •Must have a vasectomized partner
排除标准
- •Subjects must not meet any of the following exclusion criteria:
- •Impaired blood clotting (prothrombin rate <50% and/or PTT >55 sec and/or a platelet count of <50,000/μL)
- •Pregnancy and lactation
- •Contraindications to treatment with adalimumab:
- •Moderate to severe heart failure (NYHA Class III/IV)
- •Active tuberculosis
- •Severe acute infections, e.g. sepsis
- •Opportunistic infections including invasive fungal infections
- •Known hypersensitivity to any of the ingredients of the study product or to any drug with a similar chemical structure
- •Treatment with beta-receptor blocking agents (because of altered symptoms in case of possible anaphylactic reactions to IV fluorescein)
- •Any other condition or medical treatment that, in the investigator's judgment, is not compatible with participation in the trial
- •Individuals who are in a relationship of dependence on or employed by the sponsor or any of the investigators
- •Planned prolonged stay outside the region of the study site, preventing the subject from returning for scheduled visits
- •Participation in any other clinical trial or administration of any investigational drug within the last four weeks prior to the screening visit
研究组 & 干预措施
FITC-Adalimumab
Experimental
干预措施: FITC-Adalimumab (Drug)
结局指标
主要结局
Safety and tolerability of Fluoresceinisothiocyanate (FITC)-Adalimumab
时间窗: 3 months
Local Tolerability: All intestinal mucosal adverse events observed following administration of FITC-Adalimumab. Systemic Safety and Tolerability: Number of SARs during the observation period, i.e., number of SAEs whose occurrence is due to the use of FITC-Adalimumab in this clinical trial. Number of SAEs during the observation period. Number of AEs during the observation period.
次要结局
- Visual identification of FITC-Adalimumab positive intestinal mucosal cells(One minute after administration of FITC-Adalimumab)
- Number of FITC-Adalimumab positive intestinal mucosal cells(One minute after administration of FITC-Adalimumab)
- Correlation between the number of FITC-Adalimumab positive intestinal mucosal cells in inflamed gut sections and therapeutic response to Adalimumab therapy.(Three months after administration of FITC-Adalimumab)
研究者
研究点 (1)
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