Safety and Tolerability of FITC-Adalimumab Administration During Confocal Laser Endomicroscopy of the Gut
NCT ID: NCT01275508
Last Updated: 2012-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
25 participants
INTERVENTIONAL
2011-01-31
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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FITC-Adalimumab
FITC-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.
Interventions
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FITC-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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
University of Erlangen-Nürnberg Medical School
OTHER
Responsible Party
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Principal Investigators
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Markus Neurath, MD PhD
Role: STUDY_DIRECTOR
Medizinische Klinik I, University Hospital Erlangen
Raja Atreya, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Medizinische Klinik I, University Hospital Erlangen
Locations
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Medizinische Klinik I, University Hospital Erlangen
Erlangen, Bavaria, Germany
Countries
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References
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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. doi: 10.1053/j.gastro.2006.11.041. 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. doi: 10.1055/s-2002-34254.
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. doi: 10.1053/j.gastro.2004.06.050.
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. doi: 10.1038/ncponc0881.
Other Identifiers
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2010-018959-99
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
FITC-ADA 01-2010
Identifier Type: -
Identifier Source: org_study_id