Imaging of Lymphatic Vessels in People With Rheumatoid Arthritis (RA)
Recruiting · NCT05197530 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Rochester
View the official record on ClinicalTrials.gov →Interventions studied
Indocyanine greenMultiSpectral Imaging System
What this trial is about
Lymphatic transport was previously examined by these investigators using Near InfraRed Indocyanine Green fluorescence imaging (NIR-ICG) of the upper extremities. They established reliable and reproducible methodologies in RA patients. The purpose of this phase 2 pilot is to study RA disease progression and effectiveness as well as the mechanism of action of clinical interventions using established NIR-ICG methodologies in previous studies.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Early RA
- Ability to provide written informed consent
- Subjects must be 18 years old or older
- RA subjects must fulfill 2010 American College of Rheumatology (ACR) criteria with a DAS28-C-Reactive Protein (CRP) \>3.5
- Must have 1 year or less of disease
- Must be MTX inadequate responder (DAS28-CRP \>2.6 at 4 months of therapy) OR experience a flare on MTX (self-reported and score of \>25 on the Outcome Measures in Rheumatology (OMERACT) Flare questionnaire AND are starting an anti-TNF therapy.
- Must have active synovitis in one or both hands confirmed by ultrasound
- Established RA
- Ability to provide written informed consent
- Subjects must be 18 years of age or older
- RA subjects must fulfill 2010 ACR criteria with a DAS-CRP \>3.5
- Must have at least 10 years of disease
- Must have active synovitis in one or both hands confirmed by ultrasound
- Must be on a stable dose of DMARD (MTX, leflunomide, azulfidine, hydroxychloroquine), Janus Kinase (JAK) inhibitor or biologic agent for 8 weeks
Exclusion criteria
- All PATIENTS
- Active systemic disorders or inflammatory conditions other than RA, (i.e., chronic infections with hepatitis B, hepatitis C or HIV) that would confound the study results.
- Known sensitivity to iodine because of residual iodide in Indocyanine Green
- Pregnant women should not participate; pregnancy tests will not be performed
- Inability to donate blood due to poor venous access
Where it is running
1 location listed across 1 US state.
- University of Rochester - Rochester, New York, United States