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RecruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study uses a special dye and near-infrared light to take pictures of lymph vessels in the arms. It looks at how rheumatoid arthritis (RA) changes over time and how treatments work. It is for adults with RA for 1 year or less, or at least 10 years.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and able to give written consent.
  • Meet the 2010 American College of Rheumatology rules for RA, with a disease activity score above 3.5.
  • Have swelling in the lining of joints in one or both hands, confirmed by ultrasound.
  • For early RA: Have had RA for 1 year or less.
  • For early RA: Methotrexate (MTX) must not have worked well enough, with a disease activity score above 2.6 after 4 months, OR you must report a flare with a flare survey score above 25.
  • For early RA: Be starting an anti-TNF medicine, a treatment that blocks a protein involved in swelling.
  • For established RA: Have had RA for at least 10 years.
  • For established RA: Have taken a steady dose of an allowed RA medicine for 8 weeks. These include MTX, leflunomide, azulfidine, hydroxychloroquine, a JAK inhibitor, or a biologic medicine.

Who can't join

  • Have another active illness affecting the body or causing inflammation that could affect study results, such as ongoing hepatitis B, hepatitis C, or HIV infection.
  • Have a known sensitivity to iodine, because the imaging dye contains some iodide.
  • Be pregnant. The study will not do pregnancy tests.
  • Be unable to give blood because your veins are too hard to access.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (1)

NY