Cohort profile: The Applied Public-Private Research enabling OsteoArthritis Clinical Headway (IMI-APPROACH) study: a 2-year, European, cohort study to describe, validate and predict phenotypes of osteoarthritis using clinical, imaging and biochemical markers
Francis Berenbaum,
Margreet Kloppenburg,
Ida K Haugen,
Paco M J Welsing,
Floris P J G Lafeber,
Francisco J Blanco,
Ali Mobasheri,
John Loughlin,
Willem E van Spil,
Eefje M van Helvoort,
Mylène P Jansen,
Marieke Loef,
Jaume Bacardit,
Christoph H Ladel,
Anne C Bay-Jensen,
Jonathan Larkin,
Janneke Boere,
Harrie H Weinans,
Agnes Lalande,
Anne C A Marijnissen
Affiliations
Francis Berenbaum
21 Rheumatology department, Hôpital Saint-Antoine, Paris, France
Margreet Kloppenburg
Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands
Ida K Haugen
1 Center for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway
Department of Rheumatology and Clinical Immunology, University Medical Center Utrecht, Utrecht, The Netherlands
Francisco J Blanco
2 Grupo de Reumatología y Salud, Departamento de Fisioterapia y Medicina, Centro Interdisciplinar de Química e Bioloxía (CICA), Universidad de A Coruña, A Coruña, Spain
Ali Mobasheri
9 Research Unit of Medical Imaging, Physics and Technology, Faculty of Medicine, University of Oulu, Oulu, Finland
John Loughlin
Musculoskeletal Research Group, Newcastle University, Newcastle upon Tyne, UK
Willem E van Spil
Rheumatology and Clinical Immunology, UMC Utrecht, Utrecht, The Netherlands
Eefje M van Helvoort
Rheumatology and Clinical Immunology, UMC Utrecht, Utrecht, The Netherlands
Mylène P Jansen
Rheumatology and Clinical Immunology, UMC Utrecht, Utrecht, The Netherlands
Marieke Loef
1Leiden University Medical Center (LUMC), Rheumatology, Leiden, Netherlands
Jaume Bacardit
School of Computing Science, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK
Purpose The Applied Public-Private Research enabling OsteoArthritis Clinical Headway (APPROACH) consortium intends to prospectively describe in detail, preselected patients with knee osteoarthritis (OA), using conventional and novel clinical, imaging, and biochemical markers, to support OA drug development.Participants APPROACH is a prospective cohort study including 297 patients with tibiofemoral OA, according to the American College of Rheumatology classification criteria. Patients were (pre)selected from existing cohorts using machine learning models, developed on data from the CHECK cohort, to display a high likelihood of radiographic joint space width (JSW) loss and/or knee pain progression.Findings to date Selection appeared logistically feasible and baseline characteristics of the cohort demonstrated an OA population with more severe disease: age 66.5 (SD 7.1) vs 68.1 (7.7) years, min-JSW 2.5 (1.3) vs 2.1 (1.0) mm and Knee injury and Osteoarthritis Outcome Score pain 31.3 (19.7) vs 17.7 (14.6), except for age, all: p<0.001, for selected versus excluded patients, respectively. Based on the selection model, this cohort has a predicted higher chance of progression.Future plans Patients will visit the hospital again at 6, 12 and 24 months for physical examination, pain and general health questionnaires, collection of blood and urine, MRI scans, radiographs of knees and hands, CT scan of the knee, low radiation whole-body CT, HandScan, motion analysis and performance-based tests.After two years, data will show whether those patients with the highest probabilities for progression experienced disease progression as compared to those wit lower probabilities (model validation) and whether phenotypes/endotypes can be identified and predicted to facilitate targeted drug therapy.Trial registration number NCT03883568
