ear-infrared fluorescence molecular imaging of adalimumab-800CW to elucidate the drug distribution throughout inflamed tissue in inflammatory bowel disease and rheumotoid arthritis

• Conditions: inflammatory bowel disease; rheumatoid arthritis; 10017969; 10003816; 10013361

• Registration Number: NL-OMON56363
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
• Established IBD or RA diagnosis
• Active disease.
o 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 *g/g;
o RA cohort: clinically active disease of at least one joint of the hand as
assessed by rheumatologist;
• No history of previous anti-TNF therapy (anti-TNF naïve);
• 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 who are of childbearing potential, are
premenopausal with intact
reproductive organs or are less than 2 years postmenopausal
• A negative pregnancy test must be available (blood or urine)
• Willing to ensure that she uses effective contraception during the study and
for 3 months thereafter.

Disease activity scores
Crohn*s disease Ulcerative colitis
CDAI HBI
SCCAI
Clinical remission <150 0-4 <= 2
Mild activity 150-220 5-7
3-5
Moderate to severe activity 220-450 8-16 6-11
Severe fulminant >450 17-100 >= 12

Exclusion Criteria

- A potential female subject that is pregnant or provides breastfeeding will be
excluded from participation in this study;
- RA patients with a skin type above type 3 according to the Fitzpatrick scale
due to feasibility of the MDSFR/SFF spectroscopy measurements;
- Medical or psychiatric conditions that compromise the patient's ability to
give informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified