Mean (SD) baseline values, LS mean (SD) changes from baseline adjusted for baseline value (analysis of covariance), treatment effect, SRM and relative efficiency compared to AUSCAN pain in the per-protocol population (score range is shown in parentheses)
| Baseline, mean (SD) | Changes, LS mean (SD) | |||||||
|---|---|---|---|---|---|---|---|---|
| Outcome | CRx-102 (n=26) | Placebo (n=33) | CRx-102 (n=26) | Placebo (n=33) | Treatment effect (95% CI) | p Value | SRM | Relative efficiency |
| AUSCAN (0–100) | ||||||||
| Pain | 61.9 (16.6) | 63.8 (17.2) | −20.5 (21.1) | −6.2 (21.1) | 14.3 (3.2 to 25.4) | 0.012 | 0.68 | 1.00 |
| Physical | 64.9 (18.9) | 70.9 (15.5) | −12.9 (18.6) | −5.9 (18.6) | 7.0 (−2.9 to 16.8) | 0.161 | 0.37 | 0.30 |
| Stiffness | 62.9 (17.4) | 67.8 (19.8) | −20.3 (22.5) | −8.3 (22.5) | 12.0 (0.2 to 23.9) | 0.047 | 0.53 | 0.61 |
| VAS (0–100) | ||||||||
| Pain | 59.8 (19.5) | 62.9 (16.7) | −23.5 (22.3) | −6.3 (22.3) | 17.2 (5.5 to 28.9) | 0.005 | 0.77 | 1.28 |
| Global | 61.5 (17.5) | 62.5 (17.6) | −23.4 (20.4) | −4.6 (20.4) | 18.8 (8.1 to 29.5) | 0.001 | 0.92 | 1.83 |
| CRP | 2.0 (1.8) | 2.3 (2.2) | −0.2 (2.3) | 0.4 (2.3) | 0.6 (−0.7 to 1.8) | 0.364 | 0.24 | 0.12 |
| 18-TJC (0–18) | 9.8 (4.4) | 10.1 (4.5) | −4.8 (5.0) | −2.5 (5.0) | 2.3 (−0.3 to 4.9) | 0.084 | 0.46 | 0.46 |
| 18-SJC (0–18) | 5.6 (4.1) | 4.9 (4.1) | −3.1 (2.9) | −1.7 (2.8) | 1.4 (−0.1 to 2.9) | 0.059 | 0.51 | 0.56 |
| 18-LMJC (0–18) | 5.9 (5.3) | 7.6 (4.7) | −1.9 (3.6) | −1.1 (3.6) | 0.8 (−1.1 to 2.7) | 0.401 | 0.22 | 0.10 |
| 18-BEJC (0–18) | 12.8 (3.6) | 12.4 (3.9) | 0.4 (1.6) | 0.1 (1.6) | −0.4 (−1.2 to 0.5) | 0.396 | −0.23 | NA |
| HOA–PAS (0–10) | 6.2 (1.8) | 6.5 (1.5) | −2.0 (2.0) | −0.6 (2.0) | 1.4 (0.41 to 2.48) | 0.007 | 0.73 | 1.15 |
| HOA–CDAI-1 (0–66) | 34.4 (9.2) | 35.2 (8.8) | −13.4 (10.0) | −6.2 (10.0) | 7.2 (2.0 to 12.5) | 0.008 | 0.72 | 1.12 |
| HOA–CDAI-2 (0–56) | 27.5 (8.8) | 27.5 (7.7) | −12.7 (9.0) | −5.3 (9.0) | 7.4 (2.7 to 12.1) | 0.003 | 0.82 | 1.45 |
AUSCAN, Australian/Canadian osteoarthritis hand index; BEJC, bony enlargement joint count; CRP, C-reactive protein; HOA–CDAI, hand osteoarthritis clinical disease activity index; HOA–PAS, hand osteoarthritis patient activity score; LMJC, limited motion joint count; LS, least square; NA, not analysed (invalid when negative standardised response mean (SRM) value); SJC, soft tissue swelling joint count; TJC, tender joint count; VAS, visual analogue scale.
HOA–PAS: VAS pain + VAS global + AUSCAN physical.
HOA–CDAI-1: 18-TJC + 18-SJC + AUSCAN pain + AUSCAN stiffness + AUSCAN physical.
HOA–CDAI-2: 18-TJC + 18-SJC + VAS pain + VAS global.