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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: w.b.nagengast@umcg.nl
• Phone: +31503612620

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.