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

Description

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.

Conditions

Rheumatoid Arthritis

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Rheumatoid Arthritis
Intervention / Treatment

-

Contacts and Locations

Rochester

University of Rochester, Rochester, New York, United States, 14642

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Rochester,

Christopher Ritchlin, MD, MPH, PRINCIPAL_INVESTIGATOR, University of Rochester

Study Record Dates

2025-06