Osteoarthritis and Cartilage

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Osteoarthritis and Cartilage Tropomyosin-related kinase A (TrkA) inhibition for the treatment of painful knee osteoarthritis: results from a randomized controlled phase 2a trial F.E. Watt, M.B. Blauwet, A. Fakhoury, H. Jacobs, R. Smulders, N.E. Lane Osteoarthritis and Cartilage DOI: 10.1016/j.joca.2019.05.029 Copyright © 2019 The Authors Terms and Conditions

Fig. 1 Flow Chart (A) and Participant Disposition (B). Abbreviations: BID, twice daily; FAS, full analysis set; SAF, safety analysis set. *Subjects who discontinued the study during the treatment period could enter the follow-up period. Osteoarthritis and Cartilage DOI: (10.1016/j.joca.2019.05.029) Copyright © 2019 The Authors Terms and Conditions

Fig. 2 Change From Baseline and Follow-up in WOMAC Pain Subscale Score in the Index Knee. Data are presented as mean (SE). Abbreviations: EoT, end of treatment; FU, follow-up; SE, standard error. EoT results include all participants who completed the 4-week treatment and those who discontinued the study before Week 4. The change from baseline to Weeks 1, 2, and 4 results are based on repeated measures analysis, with treatment group, study site, week, and week by treatment group interaction as fixed effects and baseline and week by baseline interaction as covariates. The change from baseline to EoT result is based on an analysis of covariance with treatment group and study site as fixed effects and baseline value as a covariate. Results for the FU visits are based on descriptive statistics. *P ≤ 0.05, **P ≤ 0.01, between naproxen and placebo. Osteoarthritis and Cartilage DOI: (10.1016/j.joca.2019.05.029) Copyright © 2019 The Authors Terms and Conditions

Fig. 3 Changes From Baseline in WOMAC Subscales (A–B), Walking Pain (C), and Total (D) Scores. Abbreviation: EoT, end of treatment. Data are presented as adjusted mean (SE). EoT results include all participants who completed the 4-week treatment and those who discontinued the study before Week 4. The change from baseline to Weeks 1, 2, and 4 results are based on repeated measures analysis, with treatment group, study site, week, and week by treatment group interaction as fixed effects and baseline and week by baseline interaction as covariates. The change from baseline to EoT results are based on an analysis of covariance with treatment group and study site as fixed effects and baseline value as a covariate. **P ≤ 0.01, ***P ≤ 0.001, between naproxen and placebo. Osteoarthritis and Cartilage DOI: (10.1016/j.joca.2019.05.029) Copyright © 2019 The Authors Terms and Conditions

Fig. 4 Change From Baseline in Mean Daily Average Pain Score in the Index Knee. Abbreviations: EoT, end of treatment; NRS, numerical rating scale. NRS was recorded daily on the patient's electronic diary device; the score ranges from 0–10 (0, “no pain”; 10, “pain as bad as you can imagine”). Data are presented as mean (SE). The change from baseline to Weeks 1, 2, and 4 results are based on repeated measures analysis, with treatment group, study site, week, and week by treatment group interaction as fixed effects and baseline and week by baseline interaction as covariates. The change from baseline to EoT result is based on an analysis of covariance with treatment group and study site as fixed effects and baseline value as a covariate. *P ≤ 0.05, **P ≤ 0.01, between naproxen and placebo. Osteoarthritis and Cartilage DOI: (10.1016/j.joca.2019.05.029) Copyright © 2019 The Authors Terms and Conditions