Fluorescence Imaging of IBD and RA Using Adalimumab-800CW (STRATIFY)

This is an interventional treatment trial for IBD focused on measuring Molecular imaging, Adalimumab-800CW, Fluorescence, Inflammatory bowel disease, Rheumatoid arthritis Read More

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.