An Open-Label Pilot Study Evaluating by Magnetic Resonance Imaging the Potential for a Disease-Modifying Effect of Celecoxib Compared to a Modelized Historical Control Cohort in the Treatment of Knee Osteoarthritis

摘要: Objectives The aim of the study was to evaluate by quantitative magnetic resonance imaging effect celecoxib 200 mg daily on cartilage volume loss over 12 months in knee osteoarthritis. Methods primary outcome this medial compartment (femoral condyle and tibial plateau) assessed subjects receiving continuous treatment with for compared a modelized historical control cohort, as expressed percentage from baseline. Safety medication also assessed. Comparison observed expected evaluated multivariate linear regression model based cohort. Results For outcome, 95% confidence intervals mean cohort joint (6.81% [6.01; 7.60]) predicted (modelized cohort) (5.65% [5.10; 6.19]) overlap, indicating no significant difference hence loss. Similar findings were demonstrated lateral safety data reported several minor adverse events similar those typically seen 1-year clinical trial. Conclusions Although be safe osteoarthritis at dose, it did not provide protective Cohort modelization is an efficient unbiased way comparator group assessment novel treatments when classic head-to-head randomized controlled trials are feasible.