Crohn's DiseasePhase 1/2FA-CrohnNCT01275508
Safety and Tolerability of FITC-Adalimumab Administration During Confocal Laser Endomicroscopy of the Gut
A Phase 1/2 study testing FITC-Adalimumab in people with Crohn's Disease, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- FITC-Adalimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Apr 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Medizinische Klinik I, University Hospital Erlangen
Erlangen, Bavaria, 91054
About this study
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
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.
- Conditions
- Crohn's Disease
- Being tested
- FITC-Adalimumab
- Keywords
- Subjects with active Crohn's disease, Safety and tolerability of FITC-Adalimumab, Intestinal topical application
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FITC-AdalimumabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| FITC-Adalimumab | Experimental | Not described Receives: Drug: FITC-Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (3)
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
Measured: One minute after administration of 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
Measured: One minute after administration of 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.
Measured: Three months after administration of FITC-Adalimumab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Markus Neurath, MD PhD, Study director, Medizinische Klinik I, University Hospital ErlangenRaja Atreya, MD, PhD, Principal investigator, Medizinische Klinik I, University Hospital Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01275508
- Sponsor's protocol ID
- FITC-ADA 01-2010
- Other IDs
- 2010-018959-99
- Acronym
- FA-Crohn
- Status last verified
- Sep 2012
- First submitted
- 7 Jan 2011
- Last updated
- 14 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1053/j.gastro.2006.11.041. Epub 2006 Nov 29.
PubMed 17241859Keller 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.
PubMed 12244502Kiesslich 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.
PubMed 15362025Kiesslich 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.
PubMed 17657253
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01275508
- Acronym / sponsor ID
- FA-Crohn / FITC-ADA 01-2010
- Conditions
- Crohn's Disease
- Keywords
- Subjects with active Crohn's disease, Safety and tolerability of FITC-Adalimumab, Intestinal topical application
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Jan 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 12 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FITC-Adalimumab | Experimental | Drug: FITC-Adalimumab |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (14 listed)
- 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
- Moderate to severe heart failure (NYHA Class III/IV)
- Active tuberculosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FITC-AdalimumabThe 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. | Drug | FITC-Adalimumab |
Primary outcome
Safety and tolerability of Fluoresceinisothiocyanate (FITC)-Adalimumab
Time frame: 3 months
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.
3 secondary outcomes
Visual identification of FITC-Adalimumab positive intestinal mucosal cells
Time frame: One minute after administration of FITC-Adalimumab
Number of FITC-Adalimumab positive intestinal mucosal cells
Time frame: One minute after administration of 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2012.
- Background: PubMed 17241859Colombel 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.
- Background: PubMed 12244502Keller 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.
- Background: PubMed 15362025Kiesslich 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.
- Background: PubMed 17657253Kiesslich 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Neurath, MD PhD study director
Medizinische Klinik I, University Hospital Erlangen
Raja Atreya, MD, PhD principal investigator
Medizinische Klinik I, University Hospital Erlangen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FITC-Adalimumab in people with Crohn's Disease, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of Fluoresceinisothiocyanate (FITC)-Adalimumab (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01275508, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2012.