Inflammatory Arthritis Center Research

Advances in the treatment of inflammatory arthritis have made a dramatic difference in the lives of people with this disease. However, there is still much to be done. In the Inflammatory Arthritis Center (IAC), our goals are to expand the understanding of how and why inflammatory arthritis develops and to improve patient care. Below are some of our ongoing research projects.

Accelerating Medicines Partnership (AMP)

The Accelerating Medicines Partnership (AMP) is a multiyear NIH funded translational research project across numerous sites in the United States. At HSS, Vivian Bykerk, MD, is principal investigator (PI) with co-PIs Lionel Ivashkiv, MD, and Alessandra Pernis, MD. AMP’s primary research focus is to facilitate understanding of RA pathogenesis in differing patient subsets in order to advance aims of precision medicine. Dr. Bykerk and Laura Donlin, PhD, have developed a research program to recruit people living with RA. These patients with joint inflammation volunteer to provide their joint tissue, either at the time of surgery or via a needle biopsy along with information about their health, disease status and treatment. Their collected data will facilitate scientific studies that can discover new mechanisms in the immune system that contribute to the disease and could be targeted for treatment.

The release of the new data for public use in early 2018 speaks to the effectiveness of the AMP RA consortium, a group of engaged researchers across the USA, to provide information that will allow even more scientists to study how the immune system works in rheumatoid arthritis.

Educational Resources

Other IAC Research Studies

To be eligible for all IAC studies (except StopRA), one must be under the care of an HSS rheumatologist.

Actively Enrolling Research Trials

CATCH-US: Consortium of Early Arthritis Cohorts

A study of newly diagnosed rheumatoid arthritis (RA) patients (joint symptoms lasting for less than one year)

Patients have different experiences with their RA, requiring different levels of treatment. However, research suggests that many patients are not treated in the way that could best improve their outcomes.

The goal of CATCH-US is to better understand predictors of treatment response in early RA patients. Vivian Bykerk, MD has overseen the expansion of this observational study of ERA and RA patients to Johns Hopkins in Baltimore, MD, with additional sites in the New York area beginning in early 2018.

For additional information about CATCH-US please email Michael McNamara.

Also clinicaltrials.gov NCT identifier # NCT02386527

Accelerating Medicines Partnership (AMP) Synovial Tissues Study

Phase I of the AMP research at HSS was launched in 2014 with projects in three disease areas including rheumatoid arthritis. Patients with early or established RA who are undergoing synovectomy or synovial biopsies are asked to provide their synovial tissue for research. Patients are also asked to answer standardized patient reported outcome measures regarding their disease activity and well-being. Tissue provided for these studies will be completely de-identified and will undergo routine histologic examination and scoring for level of inflammation. Techniques used will include RNA sequencing, ATACseq, or a highly similar technology.

The NIH has recently released datasets from the phase 1 study. The release of this new data for public use speaks to the effectiveness of the AMP RA consortium to provide information that will allow even more scientists to study how the immune system works in rheumatoid arthritis.

For additional information about AMP Synovial Biopsy please email Michael McNamara.

HSS SpA Cohort

For patients diagnosed with ankylosing spondylitis (AS) and psoriatic arthritis (PsA)

IAC Investigators are interested in learning more about spondyloarthritis (SpA). We are actively collecting data on consenting patients with specific types of SpA, including ankylosing spondylitis (AS) and psoriatic arthritis (PsA). Eligible AS and PsA patients include those who, for the preceding three months, have not received biologic treatment such as adalimumab, etanercept, infliximab, golimumab, certolizumab pegol, or other biologic therapies.

Usual care for patients with AS or SpA would include regular assessments of pain, function, mobility, spine, and joint motion, etc., about twice a year. Treatment interventions may include physical therapy, analgesics, NSAIDs, DMARDs or biologic therapies. As part of the HSS SpA Cohort, this detailed information would be recorded at pre-determined intervals, along with clinical information such as disease activity, tender and swollen joint counts, dactylitis, enthesitis, and spine involvement.

For information about the HSS SpA Cohort, email Shirin Dey.

Active Research Closed to Enrollment

StopRA: Strategy to Prevent the Onset of Clinically-Apparent RA

A Multicenter, Randomized, Double-blind, and Placebo Clinical Trial

StopRA is a 3-year funded, US-based, rheumatoid arthritis prevention study, the first of its kind. It is a multicenter randomized controlled trial in which either hydroxychloroquine or placebo is administered for 1 year followed by 2 years of observation, to people identified as being at high risk of developing RA (active synovitis). These subjects will be selected because of the presence of elevations of the RA-related autoantibody anti-CCP that are greater than 2 times the normal cut-off level (i.e. anti-CCP3 ≥ 40 units), a biomarker status that is highly specific for future RA (>90%), and also indicative of the imminent onset of clinically-apparent disease. The primary endpoint of the study is the development of clinically apparent RA by 36 months.

In addition to the Inflammatory Arthritis Center at HSS, locations participating in this national study include:

Cedars-Sinai Medical Center
Emory University
Oklahoma Medical Research Foundation
University of California, Los Angeles
University of Chicago
University of Colorado
University of Minnesota
University of Pittsburgh

University of Pittsburgh
University of Michigan
University of Alabama: Bridges
Brigham & Women's Hospital
Northwell Health
U Mass Memorial Medical Center
University of Nebraska
Essential Health-Duluth
Mayo Clinic

For additional information about StopRA please email Serene Mirza or visit http://www.stop-ra.org.

Also clinicaltrials.gov NCT Identifier # NCT02603146

TARGET: Treatments Against RA and Effect on FDG PET-CT

Despite marked improvements in survival in the US population in the past 2-3 decades, rheumatoid arthritis associated mortality rates have not declined. Cardiovascular disease has been consistently identified as the leading cause of excess deaths in RA, and it is believed that this increased CV risk in RA is likely due to enhanced vascular or systemic inflammation.

TARGET (Treatments Against RA and Effect on FDG PET-CT) aims to compare the effect of two different RA treatments on cardiovascular health in patients who are considering a treatment change. The study is recruiting patients who are only taking methotrexate and are switching treatment due to a lack of improvement. The trial will randomize participants to take a TNF inhibitor (Enbrel or Humira) in addition to their Methotrexate or to take Triple Therapy (Methotrexate + Sulfasalazine + Hydroxychloroquine). Cardiovascular health will be measured by comparison of two FDG-PET/CT scans taken before and after the treatment change. Study involvement requires two FDG-PET/CT scans and six follow-up visits over a period of six months.

For additional information about TARGET please email Michael McNamara or visit http://www.targetra.org.

Also clinicaltrials.gov NCT identifier # NCT02374021

Etanercept Clinical Trial (Amgen, Inc)

The SEAM Study: Patients with RA who are already on etanercept and methotraxate

Etanercept has become a well-established agent in the management of rheumatoid arthritis or RA, and can be used either as monotherapy or in combination with methotrexate. Dr. Vivian Bykerk along with members of the Inflammatory Arthritis Center will be studying patients with RA who are already on the combination of etanercept and methotrexate, and are beginning to enroll subjects for this study which will evaluate the effectiveness of three separate treatment regimens on maintaining remission of RA:

Etanercept monotherapy
Methotrexate monotherapy
Combination etanercept plus methotrexate therapy

The clinical hypotheses are:

Etanercept monotherapy is superior to methotrexate monotherapy for maintaining remission in subjects with RA who were on etanercept plus methotrexate therapy.
Etanercept plus methotrexate therapy is superior to methotrexate monotherapy for maintaining remission in subjects with RA who were on etanercept plus methotrexate therapy.

To discuss collaboration or participation in the SEAM study, or for any additional details, please email Shirin Dey.

Complete study details including additional study sites are listed on www.ClinicalTrials.gov, NCT# 02373813.

Click here for the SEAM study

View all clinical trials at HSS

PROMIS Rheumatoid Arthritis Interview Study

PROMIS (Patient Reported Outcomes Measurement Information System)* is an NIH-funded system of highly reliable, precise measures of patient-reported health status for physical, mental, and social well-being. Recent studies suggest that PROMIS may also provide additional data that is useful during clinical visits for facilitating shared decision-making and long-term disease management. The goal of the PROMIS RA Interview Study is to study the responsiveness (sensitivity to change) of selected PROMIS measures in people with RA and establish minimally important differences for these measures. This information is necessary before measures can be adopted and used in clinical care and research.

We have completed enrollment for PROMIS at HSS. For additional information about the PROMIS RA Interview Study at HSS please email Annie Hoang.

* Information about PROMIS is available here.