Table 7.
Change in clinical secondary outcome on the FAS population (LOCF approach)
| D-10 | D30 | D90 | D180 | Test | ||
|---|---|---|---|---|---|---|
| LI | Treatment group (N = 40) | 12.5 ± 3.8 | 8.3 ± 4.1 | 8.2 ± 4.3 | 6.8 ± 4.9 | ANOVA |
| Placebo group (N = 41) | 12.5 ± 3.4 | 9.0 ± 5.0 | 8.9 ± 5.5 | 8.1 ± 5.5 | ||
| P value | 0.9500 | 0.4983 | 0.5466 | 0.3395 | ||
| Change in pain (VAS) | Treatment group (N = 40) | 65.7 ± 11.6 | 35.9 ± 21.5 | 31.4 ± 24.2 | 27.9 ± 23.2 | ANOVA |
| Placebo group (N = 41) | 66.4 ± 9.8 | 38.6 ± 21.6 | 36.2 ± 25.6 | 30.8 ± 23.9 | ||
| P value | 0.7719 | 0.5659 | 0.3939 | 0.5738 | ||
| Change in pain intensity adjusted to basal value (VAS) | Treatment group (N = 40) | – | −30.1 ± 3.4 | −34.8 ± 3.9 | −38.2 ± 3.7 | ANOVA |
| Placebo group (N = 41) | – | −27.5 ± 3.4 | −29.7 ± 3.8 | −35.2 ± 3.7 | ||
| P value | – | 0.5925 | 0.3543 | 0.5576 | ||
| Change in pain intensity responder 30% (VAS) | Treatment group (N = 40) | – | 60.0% | 70.0% | 72.5% | Chi-square test |
| Placebo group (N = 41) | – | 61.0% | 65.9% | 75.6% | ||
| P value | – | 0.9284 | 0.6894 | 0.7495 | ||
| Change in pain intensity responder 50% (VAS) | Treatment group (N = 40) | – | 50.0% | 50.0% | 57.5% | Chi-square test |
| Placebo group (N = 41) | – | 43.9% | 43.9% | 63.4% | ||
| P value | – | 0.5825 | 0.5825 | 0.5862 | ||
| %OMERACT -OARSI responders/non-responders | Treatment group (N = 40) | – | 70.0% | 70.0% | 67.5% | Chi-square test |
| Placebo group (N = 41) | – | 70.7% | 65.9% | 61.0% | ||
| P value | – | 0.9425 | 0.1597 | 0.3750 | ||
| Patient global assessment on disease activity | Treatment group (N = 40) | 6.6 ± 1.3 | 3.6 ± 1.9 | 3.4 ± 2.5 | 2.9 ± 2.1 | ANOVA |
| Placebo group (N = 41) | 6.4 ± 1.3 | 4.0 ± 2.1 | 4.1 ± 2.5 | 3.5 ± 2.4 | ||
| P value | 0.6411 | 0.447 | 0.2052 | 0.2444 |