Status:
RECRUITING
Imaging of Lymphatic Vessels in People with Rheumatoid Arthritis (RA)
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 reproduc...
Detailed Description
In preclinical studies, these investigators demonstrated that amelioration of tumor necrosis factor (TNF)-induced arthritis with anti-TNF, but not methotrexate (MTX) therapy, correlates with normaliza...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05197530
Start Date
December 30 2021
End Date
December 1 2025
Last Update
March 20 2025
Active Locations (1)
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1
University of Rochester
Rochester, New York, United States, 14642