EUCTR2014-001594-14-DE进行中（未招募）1 期
Prospective, single-centre, open-label, one-arm clinical trial, phase I/IIa, to assess the safety and tolerability and to investigate the predictive power of FITC-Adalimumab, when topically applied twice to the intestinal mucosa as an in-vitro diagnostic in the framework of a confocal laser-endomicroscopic examination of colitis ulcerosa patients with an indication for Adalimumab treatment - MAgIC
niversitätsklinikum Erlangen0 个研究点目标入组 25 人开始时间: 2014年9月22日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •?Able to give informed consent
- •?Insufficient response or contra-indications to systemic treatment with glucocorticoids or immunosuppressive agents or glucocorticoid dependency
- •?If concomitant medication,
- •Systemic glucocorticoids =20 mg/d prednisolon equivalent: stable for one week at least
- •Systemic glucocorticoids <20 mg/d prednisolon equivalent: stable for one week at least
- •MMX budesonid (9mg/day) stable for eight weeks at least
- •5-aminosalicylate: stable dose for two weeks at least and initiated since eight weeks at least
- •Immunsuppressive agents (except ciclosporine A and tacrolimus): treatment for three months at least and stable dose for eight weeks at least prior to enrolment
- •?For subjects with child-bearing potential: adequate contraception
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Colitis of unclear origin
- •Stenosis within the Framework of colitis ulcerosa
- •Fulminant course of disease
- •Toxic megacolon
- •Colectomy (done or planned), ileo-anal pouch, ileorectostomy or ileostoma
- •Proctitis only
- •Pre-treatment with adalimumab
- •Administration of vedolizumab, anti-TNF treatment within the last four weeks prior to enrolment
- •Administration of methotrexate, ciclosporine A or tacrolimus within the last eight weeks prior to enrolment
- •Compromised coagulation (Quick <50% and/or PTT >55 sec and/or thrombocytes <50.000/µl)
- •Pregnant or breast-feeding female
- •Contraindications for adalimumab treatment
- •Known hypersensitivity to an ingredient of the IMP or to a MP with similar chemical structure
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