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

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT01275508
First received: January 7, 2011
Last updated: September 13, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Crohn's Disease
 Drug: FITC-Adalimumab
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Adalimumab
U.S. FDA Resources

Further study details as provided by University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • Safety and tolerability of Fluoresceinisothiocyanate (FITC)-Adalimumab [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: One minute after administration of FITC-Adalimumab ] [ Designated as safety issue: No ]
    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 [ Time Frame: One minute after administration of FITC-Adalimumab ] [ Designated as safety issue: No ]
    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. [ Time Frame: Three months after administration of FITC-Adalimumab ] [ Designated as safety issue: No ]
    Correlation between the number of FITC-Adalimumab positive intestinal mucosal cells in inflamed gut sections and therapeutic response.


Enrollment: 25
Study Start Date: January 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FITC-Adalimumab Drug: 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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01275508

Locations
Germany
Medizinische Klinik I, University Hospital Erlangen
Erlangen, Bavaria, Germany, 91054
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Abbott
Investigators
Study Director: Markus Neurath, MD PhD Medizinische Klinik I, University Hospital Erlangen
Principal Investigator: Raja Atreya, MD, PhD Medizinische Klinik I, University Hospital Erlangen
  More Information

Publications:

Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01275508     History of Changes
Other Study ID Numbers: FITC-ADA 01-2010, 2010-018959-99
Study First Received: January 7, 2011
Last Updated: September 13, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Erlangen-Nürnberg Medical School:
Subjects with active Crohn's disease
Safety and tolerability of FITC-Adalimumab
Intestinal topical application

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
 Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on October 18, 2012