Fluorescence Imaging of IBD and RA Using Adalimumab-800CW

Sponsor
University Medical Center Groningen
Study ID
NCT03938701
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab-800CW — DRUG
    Intravenous administration of 4.5 mg, 15 mg or 25 mg 2 - 4 days prior to the fluorescence imaging
  • Fluorescence Imaging — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Aug 6, 2024
Status verified
Aug 2025
Primary completion
Mar 31, 2026
Completion
Aug 1, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1. Fluorescence imaging of inflammatory bowel disease and rheumatoid arthritis with adalimumab-800CW
    Fluorescence imaging with 4.5 mg adalimumab-800CW in inflammatory bowel disease and rheumatoid arthritis.
  • Experimental: 2. Fluorescence imaging of inflammatory bowel disease and rheumatoid arthritis with adalimumab-800CW
    Fluorescence imaging with 15 mg adalimumab-800CW in inflammatory bowel disease and rheumatoid arthritis.
  • Experimental: 3. Fluorescence imaging of inflammatory bowel disease and rheumatoid arthritis with adalimumab-800CW
    Fluorescence imaging with 25 mg adalimumab-800CW in inflammatory bowel disease and rheumatoid arthritis.
  • Experimental: 4. Fluorescence imaging of inflammatory bowel disease and rheumatoid arthritis
    Fluorescence imaging without adalimumab-800CW in inflammatory bowel disease and rheumatoid arthritis.

Primary Outcome Measure

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 [ Time Frame: Up to 30 minutes after stop tracer injection ]

Central Contacts

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