Fluorescence Imaging for the Evaluation of Disease Activity in IBD and Rheumatoid Arthritis using the fluorescent tracer OTL38 targeting the folate B receptor: a single-center pilot study.

• Conditions: Crohn's disease; reumatoid arthritis; ulcerative colitis; 10017969; 10003816

• Registration Number: NL-OMON48394
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

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

Inclusion Criteria

Rheumatoid arthritis cohort
• Start first treatment or treatment switch to (another) biological(s) in a
patient diagnosed with active Rheumatoid Arthritis (RA) by their physician in
one or both hands.;
• Age >= 18 years;
• Written informed consent.,

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
• Willing to ensure that she or her partner uses effective contraception during
the study and for 3 months thereafter.

IBD cohort
- Patient diagnosed with clinical active ulcerative colitis or Crohn*s disease
and therefore scheduled to switch to (another) biological(s);
• Age >= 18 years;
• Written informed consent.

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
• Willing to ensure that she or her partner uses effective contraception during
the study and for 3 months thereafter.

Exclusion Criteria

Rheumatoid arthritis cohort
• Received methotrexate and/or folic acid less than 7 days before tracer
infusion;
• Skin type above type 3 according to the Fitspatrick scale;
• Primary failure (no response) within the first 12 weeks after start with any
anti-TNF agent;
• Prescribed disease modifying anti-rheumatic drugs (DMARDs) at a higher dose
than 10 mg and/or no stable dose for at least 4 weeks prior to inclusion;
• Prescribed oral corticosteroids at a higher dose than 10 mg, and/or no stable
dose for at least 4 weeks prior to inclusion;
• Use of intramuscular or intravenous corticosteroids within 4 weeks prior to
inclusion;
• Prescribed non-steroidal anti-inflammatory drugs (NSAID) with no stable dose
for at least 4 weeks prior to inclusion
• Concurrent uncontrolled medical conditions according to treating medical
physician;
• Patients with a history of anaphylactic reactions or severe allergies;
• Patients with a history of allergy to any of the components of OTL38,
including folic acid;
• Treatment with any investigational drug within the previous 3 months.
• Pregnancy or breast feeding.

IBD cohort
• Concurrent uncontrolled medical conditions;
• Patients with a history of anaphylactic reactions or severe allergies;
• Patients with a history of allergy to any of the components of OTL38,
including folic acid;
• Treatment with any investigational drug within the previous 3 months;
• Pregnancy or breast feeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>General<br /><br>- Evaluating vital parameters, adverse events (AE), serious adverse events<br /><br>(SAE) and suspected unexpected serious adverse reactions (SUSAR) for safety<br /><br>assessment.<br /><br><br /><br>RA<br /><br>- Macroscopic fluorescence signals (target-to-background ratio) for detection<br /><br>of inflammation tissue, high disease activity, during imaging using a<br /><br>wide-field fluorescence camera.<br /><br><br /><br>IBD<br /><br>- Macroscopic fluorescence signals (target-to-background ratio) for detection<br /><br>of inflammation tissue, high disease activity, during endoscopy using<br /><br>fluorescence endoscopy </p><br>