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

被引：50

作者：

van Helvoort, Eefje M. ^{[1
]}

van Spil, Willem E. ^{[1
]}

Jansen, Mylene P. ^{[1
]}

Welsing, Paco M. J. ^{[1
]}

Kloppenburg, Margreet ^{[2
,3
]}

Loef, Marieke ^{[3
]}

Blanco, Francisco J. ^{[4
]}

Haugen, Ida K. ^{[5
]}

Berenbaum, Francis ^{[6
]}

Bacardit, Jaume ^{[7
]}

Ladel, Christoph H. ^{[8
]}

Loughlin, John ^{[9
]}

Bay-Jensen, Anne C. ^{[10
]}

Mobasheri, Ali ^{[11
]}

Larkin, Jonathan ^{[12
]}

Boere, Janneke ^{[13
]}

Weinans, Harrie H. ^{[1
,14
]}

Lalande, Agnes ^{[15
]}

Marijnissen, Anne C. A. ^{[1
]}

Lafeber, Floris P. J. G. ^{[1
]}

机构：

[1] UMC Utrecht, Rheumatol & Clin Immunol, Utrecht, Netherlands

[2] Leiden Univ, Clin Epidemiol, Med Ctr, Leiden, Netherlands

[3] Leiden Univ, Med Ctr, Rheumatol, Leiden, Netherlands

[4] INIBIC Hosp Univ A Coruna, Serv Reumatol, La Coruna, Spain

[5] Diakonhjemmet Hosp, Rheumatol, Oslo, Norway

[6] Sorbonne Univ, Rheumatol, Paris, France

[7] Newcastle Univ, Sch Comp Sci, Newcastle Upon Tyne, Tyne & Wear, England

[8] Merck KGaA, Merck Serono Res, Darmstadt, Germany

[9] Newcastle Univ, Musculoskeletal Res Grp, Newcastle Upon Tyne, Tyne & Wear, England

[10] Nord Biosci, Biomarkers & Res, Herlev, Denmark

[11] State Res Inst, Regenarat Med, Ctr Innovat Med, Vilnius, Lithuania

[12] GlaxoSmithKline USA, Philadelphia, PA USA

[13] Lygature, Utrecht, Netherlands

[14] Erasmus MC, Orthopaed, Rotterdam, Netherlands

[15] Inst Rech Int Servier, Suresnes, France

来源：

BMJ OPEN | 2020年 / 10卷 / 07期

关键词：

INDIVIDUAL RADIOGRAPHIC FEATURES; HAND OSTEOARTHRITIS; KNEE OSTEOARTHRITIS; BURDEN; PAIN; HIP; PROGRESSION;

D O I：

10.1136/bmjopen-2019-035101

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

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