Table 3.

Intention-to-treat and per protocol analysis of patients according to the ACR30 response after 12 weeks of treatment and reaching the Wallace inactive disease criteria after treatment for 24 and 48 weeks on the basis of the initial patient allocation into groups

Time-point	Efficacy parameter achieved	Intention-to-treat			Per protocol
		Initial combination scheme ETA + MTX	Standard consequent scheme with MTXa	p	Initial combination scheme ETA + MTX	Standard consequent scheme with MTXa	p
12	ACR30	33/35 (94.3%)	20/33 (60.6%)	0.001	33/34 (97.1%)	20/32 (62.5%)	0.001
24	Wallace inactive disease	11/35 (31.4%)	11/33 (33.3%)	> 0.999	11/33 (33.3%)	11/30 (36.7%)	0.798
48	Wallace inactive disease	17/35 (48.6%)	20/33 (60.6%)	0.342	17/32 (53.1%)	19/29 (65.5%)	0.436
48	Remission	11/35 (31.4%)	8/33 (24.2%)	0.594	11/32 (34.4%)	8/29 (27.6%)	0.593

^aAccording to treatment regimen in this group, non-responders were supposed to switch to open-label ETA+MTX combination therapy after 12 or 24 weeks of treatment if they failed to reach the effectiveness parameter corresponding to the given week

P values are based on Pearson’s χ2 test (for categorical data)