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Synovial Fluid as a Predictor of Response in Treatment of Rheumatoid Arthritis

IRB Number: 2025-1215

January 15, 2026

Institutional Review Board, Hospital for Special Surgery

The safety of our participants is our top priority. The trial/study is approved and periodically reviewed by the Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial or research study, the investigator will explain the purpose of the trial/study, its expected benefits, any possible risks or side effects, and what your role will be. If you want to join the trial/study, you must sign informed consent documents. You can leave a trial/study at any time without penalty.

For further information, see Understanding Clinical Trials/Research Studies.

Principal Investigator

Co-Investigators

Summary of Study Intervention:

Researchers at Hospital for Special Surgery are trying to learn how synovial fluid features may be able to predict treatment response in rheumatoid arthritis (RA). This study focuses on conventional synthetic disease-modifying antirheumatic drugs (csDMARD) inadequate responders that are starting a new TNF inhibitor (TNFi). Eligible patients will be asked about their RA, and we will be collecting blood and synovial fluid for analysis of identified biomarkers. In doing so, we hope to bring precision medicine to the management of RA, particularly for those who have not been able to achieve lower disease activity with first-line treatment options. Study visits include baseline and 3-month follow-up visits. Subjects will have the opportunity to discuss any questions with the research team members and their treating rheumatologist. Enrollment begins in 2026 and we aim to enroll 110 participants. 

 

Inclusion/Exclusion Criteria: 

Inclusion Criteria 

    • Age ≥ 18 years
    • Meet 1987 ACR or 2010 ACR/EULAR RA criteria
    • RF and / or anti-CCP positive*

*Note: Patients can be recruited based on any prior positive RF or CCP. For analysis of the synovial fluid, we need to know recent titers (within last 12 months) and therefore the labs will be repeated if not done within last year 

    • Patient undergoing synovial fluid aspiration of an amenable joint (shoulder, elbow, wrist, hip, knee, ankle)
    • Patient with inadequate response to csDMARDs(MTX, LEF, SSZ, HCQ) and biologic naïve*

*Note: Patients are allowed to be on current NSAID and steroid (oral or IM or intra-articular in a different joint) treatment 

    • Patient starting any TNFiwithin next 4 weeks

 

Exclusion Criteria:

    • Unable or unwilling to provide informed written consent
    • Joint replacement or other hardware in joint of interest
    • Steroid or other injection into joint of interest within prior 30 days
    • Regular use of direct oral anticoagulant therapy (DOAC), warfarin, high dose aspirin (>81 mg/day), Clopidogrel ≥75 mg/day or patients with diagnosed bleeding diathesis (e.g., hemophilia)
    • Treatment with immunosuppression for reasonother than RA

 

Contact Information for the Study:

Grace Kim-Lambert

kimlambertg@hss.edu

917.260.4514