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Peer-Reviewed Publication
Osteoarthritis Cartilage2025;33(3):383-390.March 1, 2025Clinical Trial, Phase II

Exploring a novel outcome measure of symptom progression in knee osteoarthritis utilizing a large randomized trial.

Philip G Conaghan1, Nathaniel Katz2, David J Hunter3, Ali Guermazi4, Marc C Hochberg5, Kenneth Somberg6, Julia Clive6, Chris Knight6, Mary Johnson6, Luping Zhao6, Niti Goel7
1Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, & NIHR Leeds Biomedical Research Centre, Leeds, UK. Electronic address: P.Conaghan@leeds.ac.uk.
2Tufts University, Department of Anesthesiology & Perioperative Medicine, Boston, MA, USA; Ein Sof Innovation, Boston, MA, USA.
3Sydney Musculoskeletal Health, Kolling Institute, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia; Rheumatology Department, Royal North Shore Hospital, St Leonards, Australia.
4Boston University School of Medicine, Radiology, Boston, MA, USA; VA Boston Healthcare System, Radiology, Boston, MA, USA.
5Department of Medicine, University of Maryland School of Medicine, Baltimore, MD, USA.
6Formation Bio, Inc., Research and Development, New York City, NY, USA.
7Formation Bio, Inc., Research and Development, New York City, NY, USA; Caduceus Biomedical Consulting, LLC, Durham, NC, USA; Duke University School of Medicine, Department of Medicine, Division of Rheumatology, Durham, NC, USA.

Abstract

OBJECTIVES: Explore a newly defined composite measure of symptom progression for knee osteoarthritis (KOA) in a large, randomized study of a potential disease-modifying osteoarthritis drug (DMOAD). DESIGN: Using longitudinal KOA studies, a potential composite endpoint of time to symptom progression was defined as the first occurrence of worsening of Western Ontario and McMaster Universities Osteo…

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