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Imaging of Lymphatic Vessels in People With Rheumatoid Arthritis (RA)

NCT05197530

RecruitingPhase 1

Sponsor: University of Rochester

Conditions: Rheumatoid Arthritis

Interventions: Indocyanine green, MultiSpectral Imaging System

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (1)

Rochester, New York, United States