Rheumatoid Arthritis study: Indocyanine green vs MultiSpectral Imaging System
Official title Imaging of Lymphatic Vessels in People With Rheumatoid Arthritis (RA)
ClinicalTrials.gov ID: NCT05197530
What this study is testing
What is Indocyanine green?
An investigational dye being studied for use in rheumatoid arthritis patients to help assess disease activity.
Also referred to as ICG.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see how the disease changes over time and how treatments affect the lymphatic system using a special imaging technique.
- Who it's for
- Adults who have rheumatoid arthritis.
- What's involved
- Participants will have a non‑invasive imaging test of their upper limbs that uses a safe dye and near‑infrared light to visualize lymphatic vessels.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Early RA
- Ability to provide written informed consent
- people must be 18 years old or older
- RA people 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
You likely can't join if
- All PATIENTS
- Active systemic disorders or inflammatory conditions other than RA, (i.e., chronic infections with hepatitis B, hepatitis C or HIV) that would...
- 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
See the full eligibility criteria
- Early RA
- Ability to provide written informed consent
- people must be 18 years old or older
- RA people 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...
- Must have active synovitis in one or both hands confirmed by ultrasound Established RA
- Ability to provide written informed consent
- people must be 18 years of age or older
- RA people 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Rochester, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Rochester, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.