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

Recruiting now · Phase 1

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT05197530

Run by

University of Rochester

People needed

40

Starts

2021-12-30

Expected to finish

2026-06-01

Last updated by the study team

2026-05-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

• University of Rochester — Rochester, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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