IBDPhase 2STRATIFYNCT03938701
Fluorescence Imaging of IBD and RA Using Adalimumab-800CW
A Phase 2 study testing Adalimumab-800CW and Fluorescence Imaging in people with IBD and Rheumatoid Arthritis, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IBD, Rheumatoid Arthritis
- What is being tested?
- Adalimumab-800CW and Fluorescence Imaging
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Aug 2024to 1 Aug 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, Provincie Groningen, 9713 GZ
W B Nagengast, MD, PhD, PharmD, +31503612620, w.b.nagengast@umcg.nl
About this study
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
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.
Read the detailed description
See brief summary
- Conditions
- IBD, Rheumatoid Arthritis
- Being tested
- Adalimumab-800CW, Fluorescence Imaging
- Keywords
- Molecular imaging, Adalimumab-800CW, Fluorescence, Inflammatory bowel disease, Rheumatoid arthritis
- Medical subject headings
- Arthritis, Rheumatoid, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adalimumab-800CWDrug
Also called Humira
Intravenous administration of 4.5 mg, 15 mg or 25 mg 2 - 4 days prior to the fluorescence imaging
Fluorescence ImagingDevice
Also called Quantified fluorescence molecular endoscopy
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 group | Role | What they receive |
|---|---|---|
| 1. Fluorescence imaging of inflammatory bowel disease and rheumatoid arthritis with adalimumab-800CW | Experimental | Fluorescence imaging with 4.5 mg adalimumab-800CW in inflammatory bowel disease and rheumatoid arthritis. Receives: Drug: Adalimumab-800CW; Device: Fluorescence Imaging |
| 2. Fluorescence imaging of inflammatory bowel disease and rheumatoid arthritis with adalimumab-800CW | Experimental | Fluorescence imaging with 15 mg adalimumab-800CW in inflammatory bowel disease and rheumatoid arthritis. Receives: Drug: Adalimumab-800CW; Device: Fluorescence Imaging |
| 3. Fluorescence imaging of inflammatory bowel disease and rheumatoid arthritis with adalimumab-800CW | Experimental | Fluorescence imaging with 25 mg adalimumab-800CW in inflammatory bowel disease and rheumatoid arthritis. Receives: Drug: Adalimumab-800CW; Device: Fluorescence Imaging |
| 4. Fluorescence imaging of inflammatory bowel disease and rheumatoid arthritis | Experimental | Fluorescence imaging without adalimumab-800CW in inflammatory bowel disease and rheumatoid arthritis. Receives: Device: Fluorescence Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
To determine the safety of adalimumab-800CW in inflammatory bowel disease (IBD) and rheumatoid arthritis patients by monitoring of vital signs (blood pressure, heart rate and temperature) before, during and after tracer infusion.
These vital signs are measured before tracer administration, directly after and then every 15 minutes until 1 hour after tracer administration.
Measured: Up to 30 minutes after stop tracer injection
Safety: number of participants with (serious) adverse events that are related to the administration of adalimumab-800CW
(serious) adverse events will be monitored until 24 hours after tracer administration.
Measured: Up to 24 hours after tracer injection
Discrimination of inflamed and normal tissue based on in vivo fluorescence measurements from adalimumab-800CW gained during fluorescence imaging of the hand of rheumatoid arthritis patients
The target-to-background/contrast-to-noise ratio will be calculated after fluorescence imaging. These results will be related to the gold standard clinical care to evaluate the feasibility of molecular fluorescence imaging using the tracer adalimumab-800CW for the evaluation of drug distribution in patients with rheumatoid arthritis.
Measured: Up to 1 year
Discrimination of inflamed and normal tissue based on in vivo and ex vivo fluorescence measurements from adalimumab-800CW gained during fluorescence endoscopy in patients with ulcerative colitis (UC).
The target-to-background/contrast-to-noise ratio will be calculated after fluorescence molecular endoscopy (FME) and MDSFR/SFF spectroscopy. These results will be related to the gold standard clinical care to evaluate the feasibility of fluorescence molecular endoscopy using the tracer adalimumab-800CW for the evaluation of drug distribution in patients with ulcerative colitis.
Measured: Up to 1 year
Discrimination of inflamed and normal tissue based on in vivo and ex vivo fluorescence measurements from adalimumab-800CW gained during fluorescence endoscopy in patients with Crohn's disease (CD).
The target-to-background/contrast-to-noise ratio will be calculated after fluorescence molecular endoscopy (FME) and MDSFR/SFF spectroscopy. These results will be related to the gold standard clinical care to evaluate the feasibility of fluorescence molecular endoscopy using the tracer adalimumab-800CW for the evaluation of drug distribution in patients with Crohn's disease.
Measured: Up to 1 year
Secondary outcomes (9)
The correlation between the fluorescence intensity and the disease activity measured with the DAS28 in patients with RA.
The DAS28 (Disease Activity Score 28) is developed and validated by the EULAR (European League Against Rheumatism) to measure the progress and improvement of Rheumatoid Arthritis by measuring 28 joints. When looking at these joints, both the number of joints with tenderness upon touching and swelling are counted. Furthermore, the erythrocyte sedimentation rate is measured and a patients assessment of disease activity during the preceding 7 days is measured on a scale between 0 and 100, where 0 is 'no activity' and 100 is 'highest activity possible'.
DAS28 values range from 0.49 to 9.07 while higher values mean a higher disease activity. A DAS28 below the value of 2.6 is interpreted as Remission. Between 2.6 and 3.2 as low disease activity, and between 3.2 and 5.1 as moderate. Above 5.1 is indicated as high disease activity.
Measured: Up to 1 year
Calculation of optical properties with MDSFR/SFF spectroscopy in patients with RA
To quantify the optical properties, in vivo using multi-diameter single-fiber reflectance, single-fiber fluorescence (MDSFR/SFF) spectroscopy measurements;
Measured: Up to 1 year
The correlation between fluorescence intensity and the clinical disease activity score in ulcerative colitis using the SCCAI;
The SCCAI is a diagnostic questionnaire to assess the severity of symptoms in patients with ulcerative colitis. The score ranges from 0 to 19 based on questions on topics regarding the bowel frequency, urgency of defecation, blood in stool and general health. A score of 5 or higher indicates active disease.
Measured: Up to 1 year
The correlation between fluorescence intensity and the endoscopic disease activity score in ulcerative colitis using the Mayo endoscopic subscore;
The endoscopic Mayo Score (Mayo endoscopic subscore) evaluates ulcerative colitis stage, based only on endoscopic exploration. Endoscopic activity is based upon the assessment of a few features, such as the presence of erythema, visibility of the vascular pattern, friability, erosions, spontaneous bleeding and (large) ulcerations. Each score indicates endoscopic activity: 0 = inactive disease tot 3 = severely active disease.
3-5 = mild activity 6-10 = moderate activity >10 = severe activity
Measured: Up to 1 year
The correlation between fluorescence intensity and the clinical disease activity score in Crohn's disease using the Crohn's Disease Activity Index (CDAI).
The CDAI quantifies the symptoms of patients with CD. The index consists of 8 factors, each summed after adjustment with a weighting factor. Symptoms are scored over the last 7 days and include: number of soft/liquid stools, general well being, severity of abdominal pain, number of complications, ant-diarrhea drug use, abdominal mass, hematocrit, body weight.
Remission is defined as CDAI < 150 and severe disease as CDAI > 450.
Measured: Up to 1 year
The correlation between fluorescence intensity and the disease activity score in Crohn's disease using the SES-CD score
SES-CD (Simple Endoscopic Score for Crohn Disease) is a endoscopic assessment tool for patients with Crohn's disease. Four parameters are evaluated: ulcers, surface involved by disease, surface involved by ulcerations and narrowings.
0-2 = remission 3-6 = mild endoscopic activity 7-15 = moderate endoscopic activity >15 = severe endoscopic activity
Measured: Up to 1 year
The correlation and validation of fluorescence signals detected in vivo to the pathology of biopsies for IBD patients;
Pathology findings are correlated to fluorescence signals to determine if pathology results (inflammation) correspond to fluorescence signals (high fluorescence) and vice versa, normal tissue corresponds too low fluorescence signals.
Measured: Up to 1 year
Quantification of fluorescence signals in vivo and ex vivo of inflamed and normal tissue using multi-diameter single-fiber reflectance, single-fiber fluorescence (MDSFR/SFF) spectroscopy measurements in IBD patients;
The measurements with MDSFR/SFF are performed on the same tissue: in vivo during endoscopy and ex vivo on the biopsies. Therefore they are considered as one measurement outcome.
Measurements are taken from both normal tissue and inflammation tissue.
Measured: Up to 1 year
Correlation in IBD between the detected fluorescence signals in vivo and the clinical response to induction therapy at week 14.
Values of clinical disease activity scores (SCCAI for UC and CDAI for CD) will be obtained at week 14 from the patient's electronic medical chart in order to determine the correlation with the target-to-background ratio measured at baseline during fluorescence molecular endoscopy (FME) and MDSFR/SFF spectroscopy.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start6 Aug 2024
- Primary completionMar 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IBDStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie
- Responsible party
- Sponsor
- Investigators
- Wouter B. Nagengast, MD, PhD, PharmD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03938701
- Sponsor's protocol ID
- NL75246.042.20
- Acronym
- STRATIFY
- Status last verified
- Aug 2025
- First submitted
- 25 Feb 2019
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gabriels RY, van der Waaij AM, Linssen MD, Dobosz M, Volkmer P, Jalal S, Robinson D, Hermoso MA, Lub-de Hooge MN, Festen EAM, Kats-Ugurlu G, Dijkstra G, Nagengast WB. Fluorescently labelled vedolizumab to visualise drug distribution and mucosal target cells in inflammatory bowel disease. Gut. 2024 Aug 8;73(9):1454-1463. doi: 10.1136/gutjnl-2023-331696.
PubMed 38580386
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- STRATIFY / NL75246.042.20
- Conditions
- IBD, Rheumatoid Arthritis
- Keywords
- Molecular imaging, Adalimumab-800CW, Fluorescence, Inflammatory bowel disease, Rheumatoid arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- AbbVie
- Study start
- 6 Aug 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 6 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
See brief summary
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1. Fluorescence imaging of inflammatory bowel disease and rheumatoid arthritis with adalimumab-800CW | Experimental | Drug: Adalimumab-800CW, Device: Fluorescence ImagingFluorescence imaging with 4.5 mg adalimumab-800CW in inflammatory bowel disease and rheumatoid arthritis. |
| 2. Fluorescence imaging of inflammatory bowel disease and rheumatoid arthritis with adalimumab-800CW | Experimental | Drug: Adalimumab-800CW, Device: Fluorescence ImagingFluorescence imaging with 15 mg adalimumab-800CW in inflammatory bowel disease and rheumatoid arthritis. |
| 3. Fluorescence imaging of inflammatory bowel disease and rheumatoid arthritis with adalimumab-800CW | Experimental | Drug: Adalimumab-800CW, Device: Fluorescence ImagingFluorescence imaging with 25 mg adalimumab-800CW in inflammatory bowel disease and rheumatoid arthritis. |
| 4. Fluorescence imaging of inflammatory bowel disease and rheumatoid arthritis | Experimental | Device: Fluorescence ImagingFluorescence imaging without adalimumab-800CW in inflammatory bowel disease and rheumatoid arthritis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Established IBD or RD diagnosis
- Active disease.
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adalimumab-800CWAlso: HumiraIntravenous administration of 4.5 mg, 15 mg or 25 mg 2 - 4 days prior to the fluorescence imaging | Drug | 1. Fluorescence imaging of inflammatory bowel disease and rheumatoid arthritis with adalimumab-800CW, 2. Fluorescence imaging of inflammatory bowel disease and rheumatoid arthritis with adalimumab-800CW, 3. Fluorescence imaging of inflammatory bowel disease and rheumatoid arthritis with adalimumab-800CW |
| Fluorescence ImagingAlso: Quantified fluorescence molecular endoscopyRheumatoid 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. | Device | 1. Fluorescence imaging of inflammatory bowel disease and rheumatoid arthritis with adalimumab-800CW, 2. Fluorescence imaging of inflammatory bowel disease and rheumatoid arthritis with adalimumab-800CW, 3. Fluorescence imaging of inflammatory bowel disease and rheumatoid arthritis with adalimumab-800CW, 4. Fluorescence imaging of inflammatory bowel disease and rheumatoid arthritis |
Primary outcome
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
To determine the safety of adalimumab-800CW in inflammatory bowel disease (IBD) and rheumatoid arthritis patients by monitoring of vital signs (blood pressure, heart rate and temperature) before, during and after tracer infusion. These vital signs are measured before tracer administration, directly after and then every 15 minutes until 1 hour after tracer administration.
Safety: number of participants with (serious) adverse events that are related to the administration of adalimumab-800CW
Time frame: Up to 24 hours after tracer injection
(serious) adverse events will be monitored until 24 hours after tracer administration.
Discrimination of inflamed and normal tissue based on in vivo fluorescence measurements from adalimumab-800CW gained during fluorescence imaging of the hand of rheumatoid arthritis patients
Time frame: Up to 1 year
The target-to-background/contrast-to-noise ratio will be calculated after fluorescence imaging. These results will be related to the gold standard clinical care to evaluate the feasibility of molecular fluorescence imaging using the tracer adalimumab-800CW for the evaluation of drug distribution in patients with rheumatoid arthritis.
Discrimination of inflamed and normal tissue based on in vivo and ex vivo fluorescence measurements from adalimumab-800CW gained during fluorescence endoscopy in patients with ulcerative colitis (UC).
Time frame: Up to 1 year
The target-to-background/contrast-to-noise ratio will be calculated after fluorescence molecular endoscopy (FME) and MDSFR/SFF spectroscopy. These results will be related to the gold standard clinical care to evaluate the feasibility of fluorescence molecular endoscopy using the tracer adalimumab-800CW for the evaluation of drug distribution in patients with ulcerative colitis.
Discrimination of inflamed and normal tissue based on in vivo and ex vivo fluorescence measurements from adalimumab-800CW gained during fluorescence endoscopy in patients with Crohn's disease (CD).
Time frame: Up to 1 year
The target-to-background/contrast-to-noise ratio will be calculated after fluorescence molecular endoscopy (FME) and MDSFR/SFF spectroscopy. These results will be related to the gold standard clinical care to evaluate the feasibility of fluorescence molecular endoscopy using the tracer adalimumab-800CW for the evaluation of drug distribution in patients with Crohn's disease.
9 secondary outcomes
The correlation between the fluorescence intensity and the disease activity measured with the DAS28 in patients with RA.
Time frame: Up to 1 year
Calculation of optical properties with MDSFR/SFF spectroscopy in patients with RA
Time frame: Up to 1 year
The correlation between fluorescence intensity and the clinical disease activity score in ulcerative colitis using the SCCAI;
Time frame: Up to 1 year
The correlation between fluorescence intensity and the endoscopic disease activity score in ulcerative colitis using the Mayo endoscopic subscore;
Time frame: Up to 1 year
The correlation between fluorescence intensity and the clinical disease activity score in Crohn's disease using the Crohn's Disease Activity Index (CDAI).
Time frame: Up to 1 year
The correlation between fluorescence intensity and the disease activity score in Crohn's disease using the SES-CD score
Time frame: Up to 1 year
The correlation and validation of fluorescence signals detected in vivo to the pathology of biopsies for IBD patients;
Time frame: Up to 1 year
Quantification of fluorescence signals in vivo and ex vivo of inflamed and normal tissue using multi-diameter single-fiber reflectance, single-fiber fluorescence (MDSFR/SFF) spectroscopy measurements in IBD patients;
Time frame: Up to 1 year
Correlation in IBD between the detected fluorescence signals in vivo and the clinical response to induction therapy at week 14.
Time frame: Up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Derived from this study: PubMed 38580386Gabriels RY, van der Waaij AM, Linssen MD, Dobosz M, Volkmer P, Jalal S, Robinson D, Hermoso MA, Lub-de Hooge MN, Festen EAM, Kats-Ugurlu G, Dijkstra G, Nagengast WB. Fluorescently labelled vedolizumab to visualise drug distribution and mucosal target cells in inflammatory bowel disease. Gut. 2024 Aug 8;73(9):1454-1463. doi: 10.1136/gutjnl-2023-331696.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wouter B. Nagengast, MD, PhD, PharmD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adalimumab-800CW and Fluorescence Imaging in people with IBD and Rheumatoid Arthritis, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wouter B. Nagengast, MD, PhD, PharmD (+31503612620, w.b.nagengast@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03938701, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.