Biomarkers Consortium - Treatments Against RA and Effect on FDG PET-CT (TARGET Biomarker Study)

The Biomarkers Consortium’s TARGET Biomarker Study seeks to utilize a panel of validated proteomic biomarkers of rheumatoid arthritis (RA) disease activity and inflammation to categorize baseline and disease-modifying antirheumatic drug (DMARD)-associated changes in vascular inflammation in RA patients. Cardiovascular disease is the leading cause of deaths in RA. Therapies that reduce joint inflammation might also reduce cardiovascular risk. Leveraging a NIH randomized controlled clinical trial, Treatments Against RA and Effect on FDG PET‐CT (The TARGET Trial), this companion biomarker project will compare and correlate the changes in these proteomic biomarkers with vascular and articular FDG PET-CT between two treatment regimens in methotrexate inadequate responders that represent a critical and common decision point for rheumatologists and patients: addition of a TNF inhibitor vs. addition of sulfasalazine plus hydroxychloroquine (triple therapy) to background MTX. Data from this study may also result in the identification of novel biomarkers for use as prognostic, predictive, pharmacodynamic, and/or surrogate biomarkers in trials of CV risk and RA, thus facilitating the development of new treatments in this disease area.

Goals

  • Provide comparative effectiveness data for RA therapies on CV risk.
  • Identify a proteomic based serum multi-marker of arterial inflammation and assess its responsiveness to RA treatment.
  • Evaluate the relationship between clinical measures of RA disease activity, vascular FDG PET/CT imaging, and serum biomarkers of CVD risk.

Media

FNIH Web Announcement (July 20, 2017): The FNIH Biomarkers Consortium Launches Study to Identify Cardiovascular Risk in Rheumatoid Arthritis Patients

NIH Research Portfolio Online Reporting Tools (RePORT), The TARGET Trial

Partners

Amgen, Inc.
Arthritis Foundation
Brigham and Woman’s Hospital
Columbia University
Crescendo Bioscience
Merck Sharp & Dohme Corp.
Myriad RBM
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Regeneron Pharmaceuticals, Inc.

Contact

Stephanie Cush, Scientific Project Manager, Inflammation and Immunity, scush@fnih.org