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Safety and Tolerability of FITC-Adalimumab Administration During Confocal Laser Endomicroscopy of the Gut (FA-Crohn)

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
FITC-Adalimumab
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Crohn's Disease focused on measuring Subjects with active Crohn's disease, Safety and tolerability of FITC-Adalimumab, Intestinal topical application

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medizinische Klinik I, University Hospital Erlangen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FITC-Adalimumab

Arm Description

Outcomes

Primary Outcome Measures

Safety and tolerability of Fluoresceinisothiocyanate (FITC)-Adalimumab
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 Outcome Measures

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

Full Information

First Posted
January 7, 2011
Last Updated
September 13, 2012
Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT01275508
Brief Title
Safety and Tolerability of FITC-Adalimumab Administration During Confocal Laser Endomicroscopy of the Gut
Acronym
FA-Crohn
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 Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
Abbott

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Subjects with active Crohn's disease, Safety and tolerability of FITC-Adalimumab, Intestinal topical application

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FITC-Adalimumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
FITC-Adalimumab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety and tolerability of Fluoresceinisothiocyanate (FITC)-Adalimumab
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Visual identification of FITC-Adalimumab positive intestinal mucosal cells
Description
Visual identification (yes/no) of FITC-Adalimumab positive intestinal mucosal cells by confocal laser endomicroscopy following labeling with FITC-Adalimumab
Time Frame
One minute after administration of FITC-Adalimumab
Title
Number of FITC-Adalimumab positive intestinal mucosal cells
Description
Number of FITC-Adalimumab positive intestinal mucosal cells as identified by confocal laser endomicroscopy following labeling with FITC-Adalimumab
Time Frame
One minute after administration of FITC-Adalimumab
Title
Correlation between the number of FITC-Adalimumab positive intestinal mucosal cells in inflamed gut sections and therapeutic response to Adalimumab therapy.
Description
Correlation between the number of FITC-Adalimumab positive intestinal mucosal cells in inflamed gut sections and therapeutic response.
Time Frame
Three months after administration of FITC-Adalimumab

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Neurath, MD PhD
Organizational Affiliation
Medizinische Klinik I, University Hospital Erlangen
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Raja Atreya, MD, PhD
Organizational Affiliation
Medizinische Klinik I, University Hospital Erlangen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Klinik I, University Hospital Erlangen
City
Erlangen
State/Province
Bavaria
ZIP/Postal Code
91054
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
17241859
Citation
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.
Results Reference
background
PubMed Identifier
12244502
Citation
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.
Results Reference
background
PubMed Identifier
15362025
Citation
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.
Results Reference
background
PubMed Identifier
17657253
Citation
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.
Results Reference
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Safety and Tolerability of FITC-Adalimumab Administration During Confocal Laser Endomicroscopy of the Gut

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