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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01275508
• Date of registration: 07/01/2011
• Prospective Registration: No
• Primary sponsor: University of Erlangen-Nürnberg Medical School
• Public title: Safety and Tolerability of FITC-Adalimumab Administration During Confocal Laser Endomicroscopy of the Gut FA-Crohn
• Scientific 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
• Date of first enrolment: January 2011
• Target sample size: 25
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01275508
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
• Phase: Phase 1/Phase 2

Countries of recruitment

Germany

Contacts

• Name: Markus Neurath, MD PhD
• Affiliation: Medizinische Klinik I, University Hospital Erlangen

• Name: Raja Atreya, MD, PhD
• Affiliation: Medizinische Klinik I, University Hospital Erlangen

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: FITC-Adalimumab

Primary Outcome(s)

Safety and tolerability of Fluoresceinisothiocyanate (FITC)-Adalimumab [Time Frame: 3 months]

Secondary Outcome(s)

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]

Number of FITC-Adalimumab positive intestinal mucosal cells [Time Frame: One minute after administration of FITC-Adalimumab]

Visual identification of FITC-Adalimumab positive intestinal mucosal cells [Time Frame: One minute after administration of FITC-Adalimumab]

Secondary ID(s)

FITC-ADA 01-2010

2010-018959-99

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Abbott