Results of the covariance analysis (ANCOVA)-adjusted mean values and 95%-confidence intervals for primary and secondary outcomes at W52, as well as a p-value for group comparison
Outcome | Adj. Mean HCQ | 95%-CI HCQ | Adj. Mean PBO | 95%-CI PBO | P-value HCQ x PBO | ||
---|---|---|---|---|---|---|---|
AUSCAN Function | 48.1 | 43 | 53.3 | 51.3 | 46.6 | 56 | 0.36 |
AUSCAN Pain | 26.7 | 23.9 | 29.4 | 26.5 | 23.9 | 29.1 | 0.92 |
tender joint | 6.4 | 4.8 | 7.9 | 7.1 | 5.4 | 8.7 | 0.49 |
swollen joint | 2 | 1.3 | 2.7 | 2.1 | 1.4 | 2.7 | 0.93 |
ESR (mm/h) | 8.2 | 6.9 | 9.6 | 11.7 | 10.1 | 13.5 | <0.01 |
HAQ | 0.9 | 0.8 | 1 | 0.8 | 0.7 | 0.9 | 0.46 |
Phys. Global | 3.2 | 2.8 | 3.6 | 3.5 | 3 | 3.9 | 0.39 |
Pat. Global | 4.5 | 3.9 | 5.1 | 5.2 | 4.6 | 5.8 | 0.14 |
SF36 mental | 48.8 | 46.6 | 51 | 50.8 | 48.7 | 52.8 | 0.22 |
SF36 physical | 39.8 | 38 | 41.6 | 39.9 | 38.2 | 41.6 | 0.95 |
Morning Stiffness (min) | 30.2 | 24 | 36.3 | 16.3 | 10.3 | 22.3 | 0.001 |
Modif. Kallmann Score | 53.6 | 52.1 | 55.1 | 52.8 | 51.4 | 54.2 | 0.24 |
The associated BL value or, if available, a mean value from BL and screening was included in the ANCOVA model as a covariate.