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.
To be eligible for all IAC studies (except StopRA), one must be under the care of an HSS rheumatologist.
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.
Also clinicaltrials.gov NCT identifier # NCT02386527
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
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.
Also clinicaltrials.gov NCT identifier # NCT02374021
Accelerating Medicines Partnership (AMP) Synovial Tissues Study
The Accelerating Medicines Partnership (AMP) is a public-private partnership between the National Institutes of Health (NIH), the U.S. Food and Drug Administration (FDA), 10 biopharmaceutical companies and multiple non-profit organizations to transform the current model for developing new diagnostics and treatments by jointly identifying and promising biological targets for therapeutics. The ultimate goal is to increase the number of new diagnostics and therapies for patients and reduce the time and cost of developing them.
This initial phase of the project requires tissue sample acquisition and processing. Patients with early or established RA who are undergoing standard of care synovectomy or consent to research synovial biopsies will be asked to provide their synovial tissue for research. Patients will also be asked to answer standardized patient reported outcome measures regarding their disease activity and well-being.
The tissue provided for these studies will be completely de-identified and 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.
Tissue remnants will be processed at HSS laboratories. Some may also be sent for further analytics to the AMP collaborating labs at Harvard and Stanford universities. Results will contribute to studies using novel technologies to understand states of immune activation.
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.
Our researchers often explore collaborations with the pharmaceutical industry that may benefit our patients. The IAC has begun enrolling subjects for important clinical trials:
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.
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.
The HSS Early Arthritis Initiative connects patients quickly and efficiently with a rheumatologist who can evaluate their joint pain and get each patient started on an appropriate course of treatment.