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 - Sorbonne Université Access content directly
Journal Articles BMJ Open Year : 2020

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

Eefje van Helvoort
Willem van Spil
  • Function : Author
Mylène Jansen
Paco Welsing
  • Function : Author
Margreet Kloppenburg
  • Function : Author
Marieke Loef
Francisco Blanco
Ida Haugen
  • Function : Author
Francis Berenbaum
Jaume Bacardit
  • Function : Author
Christoph Ladel
  • Function : Author
John Loughlin
  • Function : Author
Anne Bay-Jensen
  • Function : Author
Ali Mobasheri
  • Function : Author
Jonathan Larkin
  • Function : Author
Janneke Boere
  • Function : Author
Harrie Weinans
  • Function : Author
Agnes Lalande
  • Function : Author
Anne Marijnissen
  • Function : Author
Floris Lafeber
  • Function : Author

Abstract

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

Dates and versions

hal-03994459 , version 1 (17-02-2023)

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Eefje van Helvoort, Willem van Spil, Mylène Jansen, Paco Welsing, Margreet Kloppenburg, et al.. 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. BMJ Open, 2020, 10 (7), pp.e035101. ⟨10.1136/bmjopen-2019-035101⟩. ⟨hal-03994459⟩
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