Table 2

Linear time MMRM analysis of JSW for all randomised patients and analysis of JSN progressors† for all randomised patients, and KLG2 and KLG3 patients

Cindunistat
50 mg/day200 mg/dayPlacebo
Linear time MMRM analysis JSN (primary analysis)
All randomised patients*N=485N=486N=486
 LS-mean slope (mm/year)±SE−0.103±0.013−0.109±0.012−0.115±0.012
 (95% CI)(−0.128 to −0.078)(−0.134 to −0.085)(−0.139 to –0.091)
LS-mean difference in slopes (mm/year)
 Cindunistat versus placebo±SE0.012±0.0180.005±0.017
  (95% CI)(−0.023 to 0.046)(−0.029 to 0.040)
 p Value0.5090.754
JSN progressors†
All randomised patients‡N=485N=486N=486
Model-adjusted percent (95% CI)33.7% (28.5% to 39.5%)37.1% (31.8% to 42.8%)40.6% (35.1% to 46.3%)
Cindunistat versus placebo
 Adjusted OR (95% CI)0.745 (0.557 to 0.997)0.864 (0.650 to 1.150)
 p Value0.0470.317
KLG2 patients§n=216n=203n=222
Model-adjusted percent (95% CI)22.8% (16.3% to 31.0%)27.4% (20.1% to 36.2%)34.8% (26.8% to 43.8%)
Cindunistat versus placebo
 Adjusted OR (95% CI)0.553 (0.341 to 0.896)0.708 (0.441 to 1.135)
 p Value0.0160.152
KLG3 patients¶n=269n=283n=264
Model-adjusted percent (95% CI)43.3% (36.0% to 50.8%)46.7% (39.7% to 53.8%)47.6% (40.5% to 54.8%)
Cindunistat versus placebo
 Adjusted OR (95% CI)0.841 (0.581 to 1.219)0.965 (0.672 to 1.384)
 p Value0.3600.845
  • Bolded p values are significant at two-sided 0.05 α level.

  • *n=485 (cindunistat 50 mg/day), 483 (cindunistat 200 mg/day), and 486 (placebo) patients had ≥1 JSW measurement and contributed to the primary analysis.

  • †Progressors are those patients with a decrease in JSN from baseline greater than the SDD (0.199 mm) at last post-randomisation measurement.

  • ‡n=419 (cindunistat 50 mg/day), 423 (cindunistat 200 mg/day), and 429 (placebo) patients had both baseline and ≥1 post-baseline JSN measurement and contributed to the all randomised patients progressor analyses.

  • §n=182 (cindunistat 50 mg/day), 169 (cindunistat 200 mg/day), and 190 (placebo) patients had both baseline and ≥1 post-baseline JSN measurement and contributed to the KLG2 patient progressor analyses.

  • ¶n=237 (cindunistat 50 mg/day), 254 (cindunistat 200 mg/day), and 239 (placebo) patients had both baseline and ≥1 post-baseline JSN measurement and contributed to the KLG3 patient progressor analyses.

  • JSN, joint space narrowing; JSW, joint space width; KLG, Kellgren and Lawrence Grade; LS, least squares; MMRM, mixed model for repeated measures.