Home › Rheumatoid Arthritis › NCT05197530
Imaging of Lymphatic Vessels in People With Rheumatoid Arthritis (RA)
Near InfraRed Fluorescence Imaging of Lymphatic Transport Using Indocyanine Green: Phase II Pilot
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Indocyanine green (drug)
- MultiSpectral Imaging System (device)
Sponsor: University of Rochester · Participants: 40 · Started: Dec 30, 2021
Contact the study team
- Joseph Solomon, BS · Phone: 585-275-1634
Official record on ClinicalTrials.gov — NCT05197530
Locations in the U.S.
| New York | University of Rochester, Rochester |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.