Safety and Tolerability of FITC-Adalimumab Administration During Confocal Laser Endomicroscopy of the Gut

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 \<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