RT Journal Article
SR Electronic
T1 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
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e035101
DO 10.1136/bmjopen-2019-035101
VO 10
IS 7
A1 Eefje M van Helvoort
A1 Willem E van Spil
A1 Mylène P Jansen
A1 Paco M J Welsing
A1 Margreet Kloppenburg
A1 Marieke Loef
A1 Francisco J Blanco
A1 Ida K Haugen
A1 Francis Berenbaum
A1 Jaume Bacardit
A1 Christoph H Ladel
A1 John Loughlin
A1 Anne C Bay-Jensen
A1 Ali Mobasheri
A1 Jonathan Larkin
A1 Janneke Boere
A1 Harrie H Weinans
A1 Agnes Lalande
A1 Anne C A Marijnissen
A1 Floris P J G Lafeber
YR 2020
UL http://bmjopen.bmj.com/content/10/7/e035101.abstract
AB 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