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

NCT ID
NCT05197530
Registry status
Recruiting
Study type
Interventional
Phase
Phase 1
Sponsor
University of Rochester
Conditions
Rheumatoid Arthritis

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Near InfraRed Fluorescence Imaging of Lymphatic Transport Using Indocyanine Green: Phase II Pilot

Enrollment: 40 participants (Estimated).

What is being studied

  • Intervention: Heterocyclic Compounds
  • Intervention: Heterocyclic Compounds, 2-Ring
  • Intervention: Heterocyclic Compounds, Fused-Ring
  • Drug: Indocyanine green
  • Intervention: Indocyanine Green
  • Intervention: Indoles
  • Device: MultiSpectral Imaging System

Who may be eligible

Ages
18 Years to no maximum
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following 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

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

  • New York, United States: 1

Sample of listed locations

  • University of Rochester — Rochester, New York, 14642, United States — Recruiting

Study details

Start date
December 30, 2021
Primary completion date
June 1, 2026
Completion date
June 1, 2026
First posted
January 19, 2022
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH)

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT05197530
Registry last updated
May 27, 2026
QualifiedStudies registry data refreshed
October 2, 2026
QualifiedStudies record fetched
October 2, 2026

View NCT05197530 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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