Crohn's Disease
Conditions
Keywords
Subjects with active Crohn's disease, Safety and tolerability of FITC-Adalimumab, Intestinal topical application
Brief 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.
Interventions
DRUGFITC-Adalimumab
The study product FITC-Adalimumab will be topically applied via a spray catheter to the intestinal mucosa of Crohn's disease patients during endomicroscopy of the gut. One mL of the diluted study product will be applied each time to overall four selected intestinal areas at a concentration of 20 μg/mL respectively (equivalent to 20 μg of FITC-Adalimumab per area). Total amount applied will be 80 μg FITC-Adalimumab per patient.
Sponsors
Abbott
University of Erlangen-Nürnberg Medical School
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of Fluoresceinisothiocyanate (FITC)-Adalimumab | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual identification of FITC-Adalimumab positive intestinal mucosal cells | One minute after administration of FITC-Adalimumab | Visual identification (yes/no) of FITC-Adalimumab positive intestinal mucosal cells by confocal laser endomicroscopy following labeling with FITC-Adalimumab |
| Number of FITC-Adalimumab positive intestinal mucosal cells | One minute after administration of FITC-Adalimumab | Number of FITC-Adalimumab positive intestinal mucosal cells as identified by confocal laser endomicroscopy following labeling with 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 | Correlation between the number of FITC-Adalimumab positive intestinal mucosal cells in inflamed gut sections and therapeutic response. |
Countries
Germany
Outcome results
None listed