Fluorescence Imaging of IBD and RA Using Adalimumab-800CW

Launched by UNIVERSITY MEDICAL CENTER GRONINGEN · May 3, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new way to see how a medicine called adalimumab, used to treat inflammatory bowel disease (IBD) and rheumatoid arthritis (RA), spreads and works inside the body. Both IBD and RA cause ongoing inflammation—IBD affects the intestines, and RA affects the joints. Adalimumab targets a protein that causes this inflammation, but sometimes the medicine doesn’t work well for everyone, and doctors can’t always predict who will benefit. In this study, researchers have attached a special glowing dye to the medicine, allowing them to track exactly where it goes in the inflamed tissues using a special imaging system. This could help doctors better understand how the drug works and possibly tailor treatments to each person’s needs.

Adults with an active case of IBD or RA may be eligible to join, as long as they meet certain criteria, like having a confirmed diagnosis and showing signs of active disease. For people with IBD, this means scheduled for a routine bowel examination; for those with RA, having at least one actively inflamed joint in the hand. Women who can become pregnant need to have a negative pregnancy test and agree to use contraception during and after the study. Participants can expect to receive the fluorescently labeled adalimumab and undergo imaging to see where the medicine goes in their body. This study is still recruiting, and the goal is to find out if this imaging method is a useful tool to help predict who will respond well to the treatment and improve how these diseases are managed.

Gender

ALL

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.