TrialPath
Recruiting

Fluorescence Imaging of IBD and RA Using Adalimumab-800CW

NCT03938701 · University Medical Center Groningen
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
Near-infrared Fluorescence Molecular Imaging of Adalimumab-800CW to Elucidate the Drug Distribution Throughout Inflamed Tissue in Inflammatory Bowel Disease and Rheumotoid Arthritis
About this study
See brief summary
Eligibility criteria
Inclusion criteria: * Established IBD or RD 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; * 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: * 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. * The exclusion criterium that is specific for RD patients involves a skin type above type 3 according to the Fitzpatrick scale due to feasibility of the MDSFR/SFF spectroscopy measurements.
Study design
Enrollment target: 36 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-08-06
Estimated completion: 2026-08-01
Last updated: 2025-08-19
Interventions
Drug: Adalimumab-800CWDevice: Fluorescence Imaging
Primary outcomes
  • 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 (Up to 30 minutes after stop tracer injection)
  • Safety: number of participants with (serious) adverse events that are related to the administration of adalimumab-800CW (Up to 24 hours after tracer injection)
  • 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 (Up to 1 year)
Sponsor
University Medical Center Groningen · other
With: AbbVie
Contacts & investigators
ContactWouter B. Nagengast, MD, PhD, PharmD · contact · w.b.nagengast@umcg.nl · +31503612620
InvestigatorWouter B. Nagengast, MD, PhD, PharmD · principal_investigator, University Medical Center Groningen
All locations (1)
University Medical Center GroningenRecruiting
Groningen, Provincie Groningen, Netherlands
Fluorescence Imaging of IBD and RA Using Adalimumab-800CW · TrialPath