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NIR-ICG Imaging for Rheumatoid Arthritis

Phase 1

Recruiting

Led By Christopher Ritchlin, MD, MPH

Research Sponsored by University of Rochester

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Established RA: RA subjects must fulfill 2010 ACR criteria with a DAS-CRP >3.5

Early RA: RA subjects must fulfill 2010 American College of Rheumatology (ACR) criteria with a DAS28-C-Reactive Protein (CRP) >3.5

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is examining the progression of RA and the effectiveness of clinical interventions using NIR-ICG imaging, which is a reliable and reproducible method.

Who is the study for?

This trial is for adults with early or established Rheumatoid Arthritis (RA) who meet specific criteria, including being on a stable dose of certain RA medications. They must have active joint inflammation in their hands confirmed by ultrasound and not be pregnant or have other systemic disorders that could affect the study.

What is being tested?

The trial is testing how well Indocyanine Green, used with a MultiSpectral Imaging System, can track lymphatic vessel function in RA patients. It aims to understand disease progression and response to treatments using imaging techniques developed in earlier research.

What are the potential side effects?

Potential side effects may include sensitivity reactions due to residual iodide in Indocyanine Green. Participants should not have known sensitivity to iodine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with rheumatoid arthritis and my disease activity is high.

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I have early-stage rheumatoid arthritis with a DAS28-CRP score over 3.5.

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I am 18 years old or older with early rheumatoid arthritis.

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I have been on a stable dose of RA medication for 8 weeks.

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I have active hand arthritis confirmed by an ultrasound.

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I have active inflammation in my hand(s) confirmed by ultrasound.

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I have had rheumatoid arthritis for at least 10 years.

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I am 18 or older with diagnosed rheumatoid arthritis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have chronic infections like hepatitis B, C, or HIV that could affect the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clearance

Secondary study objectives

Contraction Rate

Lymphatic Vessels

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Established RA (> 10 years of disease)Experimental Treatment2 Interventions

Patients with symptomatic established RA (\>10 years) will be invited to participate in an ICG injections followed by NIR-ICG imaging and NIR-ICG imaging visit 1 week later. Total length of participation will be up to 1 week (+3 days)

Group II: Early RA (<1 year of disease)Experimental Treatment2 Interventions

In this single center study, early RA subjects (\<1 year of disease) who are MTX inadequate responders or experience a flare (see inclusion criteria for detail) on MTX and are starting an anti-TNF therapy will be invited to participate to receive ICG injections at Baseline (prior to the start of medication), week 16 and week 52. NIR-ICG imaging will be done immediately post injection and 1 week later for a total of three injection/imaging visits and three imaging visits without injections. See schedule of events for more detail. Total length of participation will be up to 53 weeks (+3days).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Indocyanine green

2016

Completed Phase 4

~1720

MultiSpectral Imaging System

2019

Completed Phase 1

~30