Crohn's disease reumatoid arthritis ulcerative colitis
Conditions
Interventions
RA
Score - the disease activity will be scored according to the symptom-based
scoring method used in rheumatology (DAS28-score).
Wide-field fluorescence imaging - Fluorescence imaging will be perform
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| General - Evaluating vital parameters, adverse events (AE), serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR) for safety assessment. RA - Macroscopic fluorescence signals (target-to-background ratio) for detection of inflammation tissue, high disease activity, during imaging using a wide-field fluorescence camera. IBD - Macroscopic fluorescence signals (target-to-background ratio) for detection of inflammation tissue, high disease activity, during endoscopy using fluorescence endoscopy | — |
Secondary
| Measure | Time frame |
|---|---|
| RA - Correlation between fluorescence imaging to the clinical disease activity score (DAS28-score). - Quantification of in vivo fluorescence signals and optical properties through analysis of MDSFR/SFF spectroscopy measurements. IBD - Quantification of fluorescence in vivo and ex vivo through analyses of MDSFR/SFF spectroscopy measurements; - Standard histopathological examination to correlate fluorescence and non-fluorescence signals detected in vivo with histology using in vivo obtained biopsies; - The localization and distribution of the OTL38 fluorescent signal at cell level observed in vivo by CLE. - Correlation between fluorescence imaging to the clinical disease activity score, the Mayo and SCCAI score, for ulcerative colitis. - Correlation between fluorescence imaging to the clinical disease activity score, the CDAI and SES-CD score, for Crohn*s disease. - Fluorescence microscopy to correlate fluorescence to localization of inflammatory cells and especially macrophage infiltration. Other study parameters - Patient characteristics (age, BMI, sex, medical history, blood pressure, pulse and temperature before and after tracer administration) | — |
Countries
Netherlands
Outcome results
None listed