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

Information source: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Crohn's Disease

Intervention: FITC-Adalimumab (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: University of Erlangen-Nürnberg Medical School

Official(s) and/or principal investigator(s):
Markus Neurath, MD PhD, Study Director, Affiliation: Medizinische Klinik I, University Hospital Erlangen
Raja Atreya, MD, PhD, Principal Investigator, Affiliation: Medizinische Klinik I, University Hospital Erlangen


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.

Clinical Details

Official title: 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

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome: Safety and tolerability of Fluoresceinisothiocyanate (FITC)-Adalimumab

Secondary outcome:

Visual identification of FITC-Adalimumab positive intestinal mucosal cells

Number of FITC-Adalimumab positive intestinal mucosal cells

Correlation between the number of FITC-Adalimumab positive intestinal mucosal cells in inflamed gut sections and therapeutic response to Adalimumab therapy.


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.


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

Locations and Contacts

Medizinische Klinik I, University Hospital Erlangen, Erlangen, Bavaria 91054, Germany
Additional Information

Related publications:

Colombel JF, Sandborn WJ, Rutgeerts P, Enns R, Hanauer SB, Panaccione R, Schreiber S, Byczkowski D, Li J, Kent JD, Pollack PF. Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial. Gastroenterology. 2007 Jan;132(1):52-65. Epub 2006 Nov 29.

Keller R, Winde G, Terpe HJ, Foerster EC, Domschke W. Fluorescence endoscopy using a fluorescein-labeled monoclonal antibody against carcinoembryonic antigen in patients with colorectal carcinoma and adenoma. Endoscopy. 2002 Oct;34(10):801-7.

Kiesslich R, Burg J, Vieth M, Gnaendiger J, Enders M, Delaney P, Polglase A, McLaren W, Janell D, Thomas S, Nafe B, Galle PR, Neurath MF. Confocal laser endoscopy for diagnosing intraepithelial neoplasias and colorectal cancer in vivo. Gastroenterology. 2004 Sep;127(3):706-13.

Kiesslich R, Goetz M, Vieth M, Galle PR, Neurath MF. Technology insight: confocal laser endoscopy for in vivo diagnosis of colorectal cancer. Nat Clin Pract Oncol. 2007 Aug;4(8):480-90. Review.

Starting date: January 2011
Last updated: September 13, 2012

Page last updated: August 23, 2015

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