PT - JOURNAL ARTICLE AU - Walter P. Maksymowych AU - Oliver FitzGerald AU - Mikkel Østergaard AU - Joanne Homik AU - Désirée van der Heijde AU - Robert G. Lambert AU - Ori Elkayam AU - Sofia Ramiro AU - J. Carter Thorne AU - Maggie J. Larché AU - Gianfranco Ferraccioli AU - Marina Backhaus AU - Gerd R. Burmester AU - Gilles Boire AU - Bernard Combe AU - Thierry Schaeverbeke AU - Alain Saraux AU - Maxime Dougados AU - Maurizio Rossini AU - Marcello Govoni AU - Luigi Sinigaglia AU - Alain Cantagrel AU - Cheryl Barnabe AU - Clifton O. Bingham III AU - Paul P. Tak AU - Dirkjan van Schaardenburg AU - Hilde Berner Hammer AU - Joel Paschke AU - Rana Dadashova AU - Edna Hutchings AU - Alexandre Sepriano AU - Robert Landewé TI - Outcomes and Findings of the International Rheumatoid Arthritis (RA) BIODAM Cohort for Validation of Soluble Biomarkers in RA AID - 10.3899/jrheum.190302 DP - 2020 Jun 01 TA - The Journal of Rheumatology PG - 796--808 VI - 47 IP - 6 4099 - http://www.jrheum.org/content/47/6/796.short 4100 - http://www.jrheum.org/content/47/6/796.full SO - J Rheumatol2020 Jun 01; 47 AB - Objective. The Outcome Measures in Rheumatology Soluble Biomarker Working Group initiated an international, multicenter, prospective study, the Rheumatoid Arthritis (RA) BIODAM cohort, to generate resources for the clinical validation of candidate biomarkers predictive of radiographic progression. This first report describes the cohort, clinical outcomes, and radiographic findings.Methods. Patients with RA from 38 sites in 10 countries starting or changing conventional synthetic disease-modifying antirheumatic drugs and/or starting tumor necrosis factor inhibitors were followed for 2 years. Participating physicians were required to adhere to a treat-to-target strategy. Biosamples (serum, urine) were acquired every 3 months, radiography of hands and feet every 6 months, and ultrasound of hands and feet every 3 months in a subset. Primary endpoint was radiographic progression by the Sharp/van der Heijde score.Results. A total of 571 patients were recruited and 439 (76.9%) completed 2-year followup. At baseline, the majority was female (76%), mean age 55.7 years, and mean disease duration 6.5 years. Patients had a mean of 8.4 swollen and 13.6 tender joints, 44-joint count Disease Activity Score (DAS44) 3.8, 77.7% rheumatoid factor–positive or anticitrullinated protein antibody–positive. Percentage of patients in DAS and American College of Rheumatology remission at 2 years was 52.2% and 27.1%, respectively. Percentage of patients with radiographic progression (> 0.5) at 1 and 2 years was 38.2% and 59.9%, respectively.Conclusion. The RA BIODAM prospective study succeeded in generating an extensive list of clinical, imaging (2343 radiographs), and biosample (4638 sera) resources that will be made available to expedite the identification and validation of biomarkers for radiographic damage endpoints. (Clinicaltrials.gov: NCT01476956, clinicaltrials.gov/ct2/show/NCT01476956)