Table 2.
Summary estimates for change in DAS28 (primary outcome measure) over 12 months
| RLC | NLC | Difference† | |||
|---|---|---|---|---|---|
| Mean (SD) | Mean (SD) | Mean (95% CI) | p Value* | ||
| Week 13 | PP (73;76)*‡ | −0.11 (1.48) | −0.04 (1.30) | −0.19 (−0.60 to 0.22) | 0.0002 |
| ITT | −0.10 (1.51) | −0.05 (1.36) | −0.15 (−0.54 to 0.23) | <0.0001 | |
| Week 26 | PP (72; 80)‡ | 0.03 (1.49) | 0.05 (1.22) | −0.15 (−0.53 to 0.24) | 0.0001 |
| ITT | 0.04 (1.52) | 0.04 (1.33) | −0.12 (−0.49 to 0.26) | 0.0001 | |
| Week 39 | PP (69; 76)‡ | 0.18 (1.61) | 0.36 (1.19) | −0.34 (−0.71 to 0.03) | <0.0001 |
| ITT | 0.20 (1.68) | 0.33 (1.33) | −0.27 (−0.64 to 0.10) | <0.0001 | |
| Week 52 | PP (70; 80)‡ | 0.18 (1.41) | 0.07 (1.22) | −0.02 (−0.40 to 0.35) | 0.0011 |
| ITT | 0.12 (1.50) | 0.08 (1.32) | −0.07 (−0.44 to 0.30) | 0.0005 | |
| Average§ | PP (64; 69)‡ | 0.02 (1.32) | 0.11 (1.05) | −0.31 (−0.63to 0.02) | <0.0001 |
| ITT | 0.06 (1.32) | 0.10 (1.10) | −0.15 (−0.45 to 0.14) | <0.0001 |
*p Values based on non-inferiority testing (ie, null hypothesis: standardised mean difference (mean difference/pooled baseline SD)=0.4; based on a clinically significant threshold of 0.6 with anticipated SD of 1.5).
†Difference in mean DAS28 change scores for the RLC group minus NLC group (adjusted for age, gender, centre and baseline DAS28 score).
‡Analysis of complete-cases (number of DAS responders—RLC group; NLC group).
§Primary endpoint evaluation.
DAS28, disease activity score in 28 joints; ITT, intention-to-treat; NLC, nurse-led clinic; PP, per protocol; RLC, rheumatologist-led clinic.