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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

From: Early combination therapy with etanercept and methotrexate in JIA patients shortens the time to reach an inactive disease state and remission: results of a double-blind placebo-controlled trial

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
  1. 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
  2. P values are based on Pearson’s χ2 test (for categorical data)