RecruitingPhase 2NCT03938701

Fluorescence Imaging of IBD and RA Using Adalimumab-800CW

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


Sponsor

University Medical Center Groningen

Enrollment

36 participants

Start Date

Aug 6, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Inflammatory bowel disease (IBD) and rheumatoid arthritis (RA) are both auto-immune diseases that are characterized by chronic relapsing inflammation of respectively the ileocolonic tissue and the synovium. Pathogenesis of both auto-immune diseases is attributed to the proinflammatory cytokine tumor necrosis factor α (TNFa). Adalimumab is a human monoclonal anti-TNF antibody used for treating patients with moderate to severely active IBD and RA. However, current rates of therapeutic nonresponsiveness to this antibody are variable and difficult to predict in advance, whereas patients are potentially exposed to a non-effective treatment and its potential side effects; while clinical deterioration progresses. A key unmet need is the development of a predictive tool for assessment of a therapeutic (non-) response to patients and finding an optimal dose strategy in individual patients before initiating anti-TNF therapy. Unfortunately, we currently lack crucial information about drug distribution of the drug of interest throughout the targeted inflamed tissue itself. Therefore, it remains unknown in both IBD and RA, if the drug reaches its target (in sufficient amounts) and how local drug concentrations are related to therapeutic response. Thus, we linked adalimumab to a fluorescent dye (adalimumab-800CW) in order to create a fluorescent signal of the labelled drug in the diseased tissue that we can visualize and quantify with dedicated optical fluorescence imaging systems. We hypothesize that this tracer will bind to TNFa in the mucosa/synovium and thus create a map of medicine distribution in vivo due to colocalization of the fluorescent labelled compound. Therefore, the aim of this study is to assess the feasibility of fluorescent molecular imaging of adalimumab-800CW in IBD and RA patients.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using a special dye attached to the drug adalimumab — a common treatment for inflammatory bowel disease (IBD) and rheumatoid arthritis (RA) — to create detailed fluorescent imaging of inflamed tissue. The goal is to develop a better way to visualize where the drug is working inside the body and to understand disease activity in real time. **You may be eligible if...** - You have a confirmed diagnosis of IBD (such as Crohn's disease or ulcerative colitis) or rheumatoid arthritis - Your disease is currently active - You are already scheduled for a procedure (such as colonoscopy or joint surgery) as part of your care **You may NOT be eligible if...** - You have a known allergy to adalimumab - You have active serious infections, including tuberculosis - You have certain immune conditions that could make the imaging dye unsafe - You are pregnant or breastfeeding - You have severe organ dysfunction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAdalimumab-800CW

Intravenous administration of 4.5 mg, 15 mg or 25 mg 2 - 4 days prior to the fluorescence imaging

DEVICEFluorescence Imaging

Rheumatoid arthritis: a flexible fiber-bundle is attached to a fluorescence camera platform to enable the detection of fluorescence signals open-air by using a black-box. Inflammatory bowel disease: a flexible fiber-bundle is attached to a fluorescence camera platform to enable the detection of fluorescence signals. The fluorescence fibre-probe is inserted through the standard working channel of the standard clinical endoscope. Fluorescence imaging will be performed during standard clinical colonoscopy.


Locations(1)

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands

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NCT03938701


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