safety and tolerability of fitc-adalimumab administration during confocal laser endomicroscopy of the gut

Conditions: Crohn's Disease

Summary: 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.


Eligibility criteria:
inclusion criteria: 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 exclusion criteria: * subjects must not meet any of the following exclusion criteria: * impaired blood clotting (prothrombin rate \ 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

Keywords: subjects with active crohn's disease safety and tolerability of fitc-adalimumab intestinal topical application