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

• Status: Active, not recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); National Institutes of Health (NIH)

Criteria

Inclusion Criteria:

Early RA

• Ability to provide written informed consent

• Subjects must be 18 years old or older

• RA subjects must fulfill 2010 ACR criteria with a DAS28-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 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), 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