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Research ArticleAccepted Article

The International RA BIODAM Cohort for Validation of Soluble Biomarkers in Rheumatoid Arthritis: Cohort Description

Walter P. Maksymowych, Oliver FitzGerald, Mikkel Østergaard, Joanne Homik, Désirée van der Heijde, Robert G. Lambert, Ori Elkayam, Sofia Ramiro, Carter Thorne, Maggie J. Larché, Gianfranco Ferraccioli, Marina Backhaus, Gerd R. Burmester, Gilles Boire, Bernard Combe, Alain Saraux, Maxime Dougados, Maurizio Rossini, Marcello Govoni, Luigi Sinigaglia, Alain Cantagrel, Renée Allaart, Cheryl Barnabe, Clifton O. Bingham III, Paul P. Tak, Dirkjan van Schaardenburg, Hilde Berner Hammer, Joel Paschke, Rana Dadashova, Edna Hutchings, Alexandre Sepriano and Robert Landewé
The Journal of Rheumatology September 2019, jrheum.190302; DOI: https://doi.org/10.3899/jrheum.190302
Walter P. Maksymowych
From the University of Alberta; CARE ARTHRITIS LTD.; Department of Rheumatology, St. Vincent’s University Hospital, Dublin, Ireland; Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet-Glostrup, University of Copenhagen, Copenhagen, Denmark; Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands; Department of Radiology, University of Alberta, Edmonton, Canada; Department of Rheumatology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; Zuyderland Medical Center, Heerlen, The Netherlands; The Arthritis Program Research Group, Newmarket, Canada Divisions of Rheumatology and Clinical Immunology and Allergy, McMaster University, Hamilton, Canada; Divisions of Rheumatology and Internal Medicine Catholic University of the Sacred Heart, Rome, Italy; Department of Rheumatology and Clinical Immunology, Charité University Hospital, Berlin, Germany; Rheumatology Department, CIUSSS de l’Estrie-CHUS, Université de Sherbrooke, Sherbrooke, Canada; Departement de rhumatologie, Univ Montpellier, CHU Montpellier, Montpellier, France; Service de rhumatologie, CHU Brest, and LBAI, U1227, Univ Brest, Inserm, F-29200 Brest, France; Paris Descartes University, Rheumatology Department, Cochin Hospital, Assistance Publique-Hôpitaux de Paris, INSERM (U1153): Clinical Epidemiology and Biostatistics, PRES Sorbonne Paris-Cité, FRANCE; Department of Rheumatology, Università di Verona, Verona, Italy St Anna Hospital, Ferrara (loc. Cona), Italy; Department of Rheumatology, Istituto Ortopedico Gaetano Pini, Milano, Italy; Centre de Rhumatologie, Hôpital Pierre Paul Riquet – Purpan. CHU de Toulouse, Toulouse, France; Department of Rheumatology, Leiden University Medical Centre, Leiden, The Netherlands; Departments of Medicine and Community Health Services, Cumming School of Medicine University of Calgary, Calgary, Canada; Divisions of Rheumatology and Allergy and Clinical Immunology, Johns Hopkins University, Baltimore, USA; Academic Medical Center, Amsterdam University Medical Center, Amsterdam, The Netherlands; Amsterdam Rheumatology and immunology Center, locations Reade and Amsterdam, University Medical Center, Amsterdam, The Netherlands; Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway; Academic Medical Center / University of Amsterdam, Amsterdam, The Netherlands and Zuyderland Medical Center, Heerlen, The Netherlands
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Oliver FitzGerald
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Mikkel Østergaard
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Joanne Homik
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Désirée van der Heijde
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Robert G. Lambert
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Ori Elkayam
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Sofia Ramiro
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Carter Thorne
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Maggie J. Larché
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Gianfranco Ferraccioli
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Marina Backhaus
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Gerd R. Burmester
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Gilles Boire
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Bernard Combe
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Alain Saraux
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Maxime Dougados
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Maurizio Rossini
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Marcello Govoni
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Luigi Sinigaglia
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Alain Cantagrel
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Renée Allaart
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Cheryl Barnabe
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Clifton O. Bingham III
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Paul P. Tak
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Dirkjan van Schaardenburg
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Hilde Berner Hammer
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Joel Paschke
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Rana Dadashova
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Edna Hutchings
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Alexandre Sepriano
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Robert Landewé
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Abstract

Objective The OMERACT Soluble Biomarker Working Group initiated an international, multicenter, prospective study, The Rheumatoid Arthritis (RA) BIODAM cohort (NCT01476956), 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 RA patients from 38 sites in 10 countries starting or changing conventional synthetic diseasemodifying anti-rheumatic (csDMARDs) drugs and/or starting tumor necrosis factor inhibitor (TNFi) reserved. 5 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 (vdHm-SHS) score.

Results A total of 571 patients were recruited and 439 (76.9%) completed 2-year follow-up. 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, DAS44 3.8, 77.7% rheumatoid factor (RF) or anti-citrullinated peptide antibody (ACPA) positive. Percentage of patients in DAS and ACR 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 38.3% and 59.8%, 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.

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The Journal of Rheumatology
Vol. 52, Issue 6
1 Jun 2025
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Accepted manuscript
The International RA BIODAM Cohort for Validation of Soluble Biomarkers in Rheumatoid Arthritis: Cohort Description
Walter P. Maksymowych, Oliver FitzGerald, Mikkel Østergaard, Joanne Homik, Désirée van der Heijde, Robert G. Lambert, Ori Elkayam, Sofia Ramiro, Carter Thorne, Maggie J. Larché, Gianfranco Ferraccioli, Marina Backhaus, Gerd R. Burmester, Gilles Boire, Bernard Combe, Alain Saraux, Maxime Dougados, Maurizio Rossini, Marcello Govoni, Luigi Sinigaglia, Alain Cantagrel, Renée Allaart, Cheryl Barnabe, Clifton O. Bingham, Paul P. Tak, Dirkjan van Schaardenburg, Hilde Berner Hammer, Joel Paschke, Rana Dadashova, Edna Hutchings, Alexandre Sepriano, Robert Landewé
The Journal of Rheumatology Sep 2019, jrheum.190302; DOI: 10.3899/jrheum.190302

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Accepted manuscript
The International RA BIODAM Cohort for Validation of Soluble Biomarkers in Rheumatoid Arthritis: Cohort Description
Walter P. Maksymowych, Oliver FitzGerald, Mikkel Østergaard, Joanne Homik, Désirée van der Heijde, Robert G. Lambert, Ori Elkayam, Sofia Ramiro, Carter Thorne, Maggie J. Larché, Gianfranco Ferraccioli, Marina Backhaus, Gerd R. Burmester, Gilles Boire, Bernard Combe, Alain Saraux, Maxime Dougados, Maurizio Rossini, Marcello Govoni, Luigi Sinigaglia, Alain Cantagrel, Renée Allaart, Cheryl Barnabe, Clifton O. Bingham, Paul P. Tak, Dirkjan van Schaardenburg, Hilde Berner Hammer, Joel Paschke, Rana Dadashova, Edna Hutchings, Alexandre Sepriano, Robert Landewé
The Journal of Rheumatology Sep 2019, jrheum.190302; DOI: 10.3899/jrheum.190302
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