[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100454437":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":36,"centralContacts":40,"locations":47,"responsibleParty":63,"collaborators":66,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":45,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":45,"enrollmentInfo":81,"targetDuration":45,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":49,"whyStopped":45,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"University of Rochester","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Early RA (\u003C1 year of disease)","EXPERIMENTAL","In this single center study, early RA subjects (\\\u003C1 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\u002Fimaging 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).",[13,14],"Drug: Indocyanine green","Device: MultiSpectral Imaging System",{"label":16,"type":10,"description":17,"interventionNames":18},"Established RA (> 10 years of disease)","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)",[13,14],[20,29],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Indocyanine green","A trained physician will inject 0.1 ml of the ICG in to the web spaces of the hands in both upper extremities.",[9,16],[26,27,28],"ICG","IC-Green","1748-701-02",{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DEVICE","MultiSpectral Imaging System","Once the ICG is injected, the contrast is expected to fluoresce underneath the MultiSpectral Imaging System. Multispectral video and still images will be recorded at the study visits.",[9,16],[35],"MSImager",[37],{"name":38,"affiliation":5,"role":39},"Christopher Ritchlin, MD, MPH","PRINCIPAL_INVESTIGATOR",[41],{"name":42,"role":43,"phone":44,"phoneExt":45,"email":46},"Joseph Solomon, BS","CONTACT","585-275-1634",null,"joseph_solomon@urmc.rochester.edu",[48],{"facility":5,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Rochester","New York","14642","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-77.61556,43.15478,{"lat":59,"lon":58},[62],{"name":42,"role":43,"phone":44,"phoneExt":45,"email":46},{"type":39,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"Christopher Ritchlin","Professor",[67,70],{"name":68,"class":69},"National Institutes of Health (NIH)","NIH",{"name":71,"class":69},"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)","100454437","phase-1-imaging-of-lymphatic-vessels-in-people-with-rheumatoid-arthritis-ra-100454437",false,"NCT05197530","Imaging of Lymphatic Vessels in People With Rheumatoid Arthritis (RA)","Near InfraRed Fluorescence Imaging of Lymphatic Transport Using Indocyanine Green: Phase II Pilot","Inclusion Criteria:\n\nEarly RA\n\n* Ability to provide written informed consent\n* Subjects must be 18 years old or older\n* RA subjects must fulfill 2010 American College of Rheumatology (ACR) criteria with a DAS28-C-Reactive Protein (CRP) \\>3.5\n* Must have 1 year or less of disease\n* 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.\n* Must have active synovitis in one or both hands confirmed by ultrasound\n\nEstablished RA\n\n* Ability to provide written informed consent\n* Subjects must be 18 years of age or older\n* RA subjects must fulfill 2010 ACR criteria with a DAS-CRP \\>3.5\n* Must have at least 10 years of disease\n* Must have active synovitis in one or both hands confirmed by ultrasound\n* Must be on a stable dose of DMARD (MTX, leflunomide, azulfidine, hydroxychloroquine), Janus Kinase (JAK) inhibitor or biologic agent for 8 weeks\n\nExclusion Criteria: All PATIENTS\n\n* 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.\n* Known sensitivity to iodine because of residual iodide in Indocyanine Green\n* Pregnant women should not participate; pregnancy tests will not be performed\n* Inability to donate blood due to poor venous access","ALL","18 Years",{"count":82,"type":83},40,"ESTIMATED","INTERVENTIONAL",[86],"PHASE1","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.",[89],"Rheumatoid Arthritis",[91,92,93,94,26,89,35],"Near InfraRed","Lymphatic Transport","Imaging","Indocyanine Green","2026-05-22",{"date":97,"type":98},"2026-05-27","ACTUAL",{"date":100,"type":98},"2021-12-30",{"date":102,"type":83},"2026-06",{"name":5,"class":6},1]