Research

(Synovial Tissues) Rheumatoid Arthritis (RA) & Early Rheumatoid Arthritis (ERA) tissue study – Recruitment of patients undergoing synovectomy or upper extremity surgery (UES) or synovial biopsies.

IRB Number: 2014-317

Institutional Review Board, Hospital for Special Surgery

October 27, 2016

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an 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, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

Vivian P. Bykerk, BSc, MD, FRCPC

Co-Investigators

Sarah Grond
Anh Hoang
Yoshimi Endo, MD 
Carey Ford
Kathryn Oi
Daisy Crego 
Luvana Chowdhury 
Laura Donlin, PhD
Serene Mirza 
Ian Cohn 
Shirin Dey 
Yurii Chinenov
Ogonna Kenechi Nwawka, MD 
Miguel Otero, PhD
Alessandra Pernis, MD 
Keerthi Caroline Sadanala 
Dalit Ashany, MD
Roseann Zeldin 
Susan M. Goodman, MD
JohnA.Carrino
Lionel B. Ivashkiv, MD
Edward F. DiCarlo, MD
Pantelis Pavlakis 
Ed Purdue, PhD 
Karmela Chan 
Caroline Reidy
Edd Ricker
Sanjay Gupta 
Michela Manni 
Michael McNamara 
Woelsung Yi, PhD 
Cristina Rozo 
Lisa A. Mandl, MD, MPH

Summary

Enrollment Target: 110

Start of study: March 2016

Patients with early or established RA who are undergoing synovectomy, upper extremity surgery (UES) or synovial biopsies will be asked to provide their synovial tissue that is being excised during surgery for research. They may also be asked to provide a blood sample and permission to review their chart to confirm their disease, diagnosis and medication use history. Patients will also be asked to answer standardized patient reported outcome measures regarding their disease activity and well-being. 

Patients with ERA whose diagnosis or prognosis is uncertain or who require joint aspiration injection will be invited to have a synovial biopsy performed by a radiologist or rheumatologist trained to perform this under ultrasound guidance. The tissue obtained will undergo routine histologic examination and scoring for level of inflammation. Any tissue remnants will be processed for cell staining, genetic, and epigenetic/transcriptonic examination. Techniques used will include RNA sequencing, ATACseq, or a highly similar technology. The tissue will be de-identified and scientists performing experiments on the tissue will have no knowledge of the patients’ clinical history. Results from these procedures are part of the preliminary studies examining the utility of novel technologies to understand states of immune activation.

There will not be any follow-up for the people who donate tissue from their surgical procedure.

Some people who have a biopsy may be invited to have a second biopsy 3-6 months later, if they rheumatologist feels that they have had an incomplete response to their medications. 

Inclusion/Exclusion Criteria

Inclusion Criteria for Synovectomy Subjects:

For subjects with suspected, early or established Rheumatoid Arthritis Undergoing Synovectomy:

1.  Age 18

2. Patients eligible for inclusion will include those patients with established, early or suspected RA:  

a.       undergoing synovectomy for therapeutic or diagnostic purposes, or

b.      undergoing upper extremity surgery and will have synovial tissue removed as part of their procedure

3. Able and willing to sign informed consent.

4. Able to understand and read English.

 

For subjects undergoing synovial biopsy(ies):

1.                Age 18

2.                Patients eligible for inclusion will include those patients with established, early or suspected RA who are:

a.       undergoing ultrasound-guided injection for treatment or ultrasound for diagnostic purposes who are willing to have a synovial tissue sample extracted

b.      those who are willing to undergo joint ultrasound and ultrasound guided synovial biopsy for the purpose of research

3.                Able and willing to sign informed consent.

4.                Able to understand and read English.

 

 For subjects with Osteoarthritis (control subjects):

1.                   Age ≥ 18

2.                   Patient eligible for inclusion will include those:

a.                   Diagnosed with OA and undergoing synovectomy

b.                  Diagnosed with OA and undergoing carpometacarpal (CMC) surgery

3.                   Able and willing to sign informed consent.

4.                   Able to understand and read English.

 

For ultrasound-guided synovial biopsy:

1.                   Age > 18

2.                   Platelet count > 100,000

3.                   No anti-coagulant use in the past 2 weeks, including ASA > 81mg/day

4.                   No history of a blood disorder

5.                   No history of local anesthesia allergy

6.                   Able and willing to sign informed consent

7.                   Able to understand and read English

 

Exclusion Criteria for all:

1.                   Age < 18

2.                   Diagnosis of other rheumatic disease (SLE, gout, etc.)

3.                   Any active malignancy excluding non-melanomatous skin cancer

4.                   Known bleeding diathesis for those undergoing percutaneous needle biopsy.

5.                   IA steroid or HA injection within  the past month

6.                   Unable or unwilling to sign informed consent

7.                   Unable to understand or read English.

Contact Information

Michael McNamara
McNamaraM@hss.edu
917-260-4906

Vivian Bykerk, MD
BykerkV@hss.edu
212-774-7520