Fluorescence Imaging of IBD and RA Using Adalimumab-800CW
Phase 2 · Testing Adalimumab-800CW and Fluorescence Imaging · 1 site · University Medical Center Groningen
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Adalimumab-800CW (a drug) and Fluorescence Imaging (a device) as a possible treatment. Condition(s) listed: IBD and Rheumatoid Arthritis.
It is open-label: participants know what they are receiving.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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…
Plus 7 more requirement(s). There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 36 participants are expected to take part.
- Start date: 2024-08-06.
- Main results expected around 2026-03 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Netherlands.
Main thing being measured
- 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 (Up to 30 minutes after stop tracer injection)
In the researchers’ words
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).
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | IBD; Rheumatoid Arthritis |
| Lead sponsor | University Medical Center Groningen |
| Collaborators | AbbVie |
| Enrollment | 36 (estimated) |
| Start date | 2024-08-06 |
| Primary completion (est.) | 2026-03 |
| First posted | 2019-05-06 |
| Last updated | 2025-08-19 |
| Official title | Near-infrared Fluorescence Molecular Imaging of Adalimumab-800CW to Elucidate the Drug Distribution Throughout Inflamed Tissue in Inflammatory Bowel Disease and Rheumotoid Arthritis |
| ClinicalTrials.gov ID | NCT03938701 |
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 …
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| University Medical Center Groningen | Groningen, Provincie Groningen | Netherlands | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.