Fluorescence imaging with labeled adalimumab to map inflammation in IBD and rheumatoid arthritis

Near-infrared Fluorescence Molecular Imaging of Adalimumab-800CW to Elucidate the Drug Distribution Throughout Inflamed Tissue in Inflammatory Bowel Disease and Rheumotoid Arthritis

This trial will test whether a fluorescent version of adalimumab can highlight inflamed bowel tissue or hand joints in adults with active IBD or rheumatoid arthritis.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Medical Center Groningen (other)
• Drugs / interventions: Adalimumab
• Locations: 1 site (Groningen, Provincie Groningen)
• Trial ID: NCT03938701 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional study administers adalimumab labeled with a near‑infrared fluorescent dye (adalimumab‑800CW) and uses fluorescence imaging to visualize drug binding in inflamed ileocolonic tissue for IBD patients and in affected hand joints for RA patients. IBD participants must already have an ileocolonoscopy scheduled so imaging can be performed during the procedure, while RA participants undergo joint imaging. The goal is to map local drug distribution and target engagement in vivo to see if imaging patterns correlate with therapeutic response. The study is single‑centered and conducted at the University Medical Center Groningen.

Who should consider this trial

Good fit: Adults (18+) with an established diagnosis of active IBD or active RA, who are mentally competent and can give written informed consent, with IBD patients already scheduled for an ileocolonoscopy.

Not a fit: People in clinical remission, those under 18, pregnant individuals, or patients with conditions that make imaging or colonoscopy unsafe are unlikely to benefit from this procedure.

Why it matters

Potential benefit: If successful, this approach could help predict who will respond to anti‑TNF therapy and guide personalized dosing to avoid ineffective treatment and side effects.

How similar studies have performed: Early‑phase and preclinical molecular imaging studies using fluorescently labeled antibodies have shown promising localization of targets, but the specific use of adalimumab‑800CW in IBD and RA remains relatively novel.

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.

Where this trial is running

Groningen, Provincie Groningen

• University Medical Center Groningen — Groningen, Provincie Groningen, Netherlands (RECRUITING)

Study contacts

• Principal investigator: Wouter B. Nagengast, MD, PhD, PharmD — University Medical Center Groningen
• Study coordinator: Wouter B. Nagengast, MD, PhD, PharmD

Conditions: IBD, Rheumatoid Arthritis, Molecular imaging, Adalimumab-800CW, Fluorescence, Inflammatory bowel disease, Rheumatoid arthritis