Fluorescence Imaging of Disease Activity in IBD and Rheumatoid Arthritis Using OTL38

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Rheumatoid Arthritis (RA) and inflammatory bowel disease (IBD) are both inflammatory diseases caused by a persistent chronic inflammation. A chronic inflammation is caused by the absence of the inflammation response resolution. Currently, diagnosis and disease activity measurements are based on symptom-based scores or on anatomical imaging devices. Both methods are unable to detect both early stages of the disease and early changes in inflammation as a reaction to treatment. Objective, early measures of inflammation could improve diagnosis and in the future therapeutic outcomes by identifying early therapy responders and non-responders. The aim of this feasibility study is to evaluate the safety and feasibility of the near infrared (NIR) tracer OTL38 for monitoring disease activity in inflammatory diseases rheumatoid arthritis and inflammatory bowel disease. The hypothesis is that OTL38 will accumulate in inflamed tissue due to the increased presence of activated macrophages expressing the folate beta receptor, enabling better visualization and monitoring of the inflammation. It is expected that this approach can improve treatment and diagnosis of patients with inflammatory disease.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Center Groningen
• Collaborators: GlaxoSmithKline; On Target Laboratories, LLC; VU University Medical Center

Criteria

Inclusion Criteria Rheumatoid Arthritis:

• 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.

Exclusion Criteria rheumatoid arthritis:

• 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.

Inclusion Criteria IBD:

• 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 IBD:

• 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.