Fluorescence Imaging of IBD and RA Using Adalimumab-800CW

• Register: ClinicalTrials.gov
• Last refreshed on: 15 May 2023
• Main ID: NCT03938701
• Date of registration: 25/02/2019
• Prospective Registration: Yes
• Primary sponsor: University Medical Center Groningen
• Public title: Fluorescence Imaging of IBD and RA Using Adalimumab-800CW STRATIFY
• Scientific title: Near-infrared Fluorescence Molecular Imaging of Adalimumab-800CW to Elucidate the Drug Distribution Throughout Inflamed Tissue in Inflammatory Bowel Disease and Rheumotoid Arthritis
• Date of first enrolment: June 2023
• Target sample size: 30
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT03938701
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Netherlands

Contacts

• Name: W B Nagengast, MD, PhD, PharmD

• Name: Wouter B. Nagengast, MD, PhD, PharmD
• Affiliation: University Medical Center Groningen

• Name: Wouter B. Nagengast, MD, PhD, PharmD

Key inclusion & exclusion criteria

Inclusion criteria:

- Established IBD or RA diagnosis Active disease.

- IBD cohort: clinically active disease of the bowel defined either clinically as at
least mild activity using dedicated scoring indices (for definitions of disease
activity, see below) or biochemically active disease as defined by a faecal
calprotectin > 200 µg/g;

- RA cohort: clinically active disease of at least one joint of the hand as assessed by
a rheumatologist;

- No history of previous anti-TNF therapy (anti-TNF naïve);

- Age of 18 years or older and mentally competent;

- Written informed consent.

IBD patients must already have an ileocolonoscopy scheduled due to a clinical indication.

For female subjects which are of childbearing potential, are premenopausal with intact
reproductive organs or are less than 2 years postmenopausal

- A negative pregnancy test must be available

- Willing to ensure that she uses effective contraception during the study and for 3
months thereafter.

Exclusion criteria:

- The use of Methotrexate during the execution of the trial.

- Medical or psychiatric conditions that compromise the patient's ability to give
informed consent;

- A potential female subject that is pregnant or provides breastfeeding will be excluded
from participation in this study.

- RA patients with a skin type above type 3 according to the Fitzpatrick scale due to
feasibility of the MDSFR/SFF spectroscopy measurements.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

IBD

Intervention(s)

Device: Fluorescence Imaging

Drug: Adalimumab-800CW

Primary Outcome(s)

Discrimination of inflamed and normal tissue based on in vivo and ex vivo fluorescence measurements from adalimumab-800CW gained during fluorescence endoscopy in patients with ulcerative colitis (UC). [Time Frame: Up to 1 year]

Discrimination of inflamed and normal tissue based on in vivo fluorescence measurements from adalimumab-800CW gained during fluorescence imaging of the hand of rheumatoid arthritis patients [Time Frame: Up to 1 year]

Discrimination of inflamed and normal tissue based on in vivo and ex vivo fluorescence measurements from adalimumab-800CW gained during fluorescence endoscopy in patients with Crohn's disease (CD). [Time Frame: Up to 1 year]

Safety: number of participants with (serious) adverse events that are related to the administration of adalimumab-800CW [Time Frame: Up to 24 hours after tracer injection]

Safety: number of participants with symptoms or changes in vital signs (blood pressure, heart rate and temperature) that are related to administration of adalimumab-800CW [Time Frame: Up to 30 minutes after stop tracer injection]

Secondary Outcome(s)

The correlation between the fluorescence intensity and the disease activity measured with the DAS28 in patients with RA. [Time Frame: Up to 1 year]

Calculation of optical properties with MDSFR/SFF spectroscopy in patients with RA [Time Frame: Up to 1 year]

Quantification of fluorescence signals in vivo and ex vivo of inflamed and normal tissue using multi-diameter single-fiber reflectance, single-fiber fluorescence (MDSFR/SFF) spectroscopy measurements in IBD patients; [Time Frame: Up to 1 year]

The correlation and validation of fluorescence signals detected in vivo to the pathology of biopsies for IBD patients; [Time Frame: Up to 1 year]

The correlation between fluorescence intensity and the clinical disease activity score in Crohn's disease using the Crohn's Disease Activity Index (CDAI). [Time Frame: Up to 1 year]

The correlation between fluorescence intensity and the clinical disease activity score in ulcerative colitis using the SCCAI; [Time Frame: Up to 1 year]

The correlation between fluorescence intensity and the endoscopic disease activity score in ulcerative colitis using the Mayo endoscopic subscore; [Time Frame: Up to 1 year]

Correlation in IBD between the detected fluorescence signals in vivo and the clinical response to induction therapy at week 14. [Time Frame: Up to 1 year]

The correlation between fluorescence intensity and the disease activity score in Crohn's disease using the SES-CD score [Time Frame: Up to 1 year]

Secondary ID(s)

NL75246.042.20

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

AbbVie