Fig. 1.

Patient disposition

^aFive patients were excluded from all analysis populations because of significant Good Clinical Practice non-compliance of the study centre.

^bThree patients (1 in the CT-P13 s.c. arm and 2 in the i.v. arm) with at least one major protocol deviation and 1 patient (in the CT-P13 s.c. arm) with no efficacy assessment after week 6 were excluded from the efficacy population.

^cOne patient randomized to the CT-P13 i.v. arm received CT-P13 s.c. treatment instead of placebo s.c. treatment at week 14, thus receiving both CT-P13 i.v. 3 mg/kg and CT-P13 s.c. 120 mg at week 14. This patient was included in the CT-P13 s.c. arm for the PD and safety populations and excluded from the efficacy and PK populations.

^dOne patient with a major protocol deviation (CT-P13 i.v. arm) and 2 patients without PK concentration data (1 in each of the CT-P13 s.c. and i.v. arms) were excluded from the PK population.

^eAll 168 patients eligible for usability assessment (patients in Bulgaria, Poland and Russian Federation continuing the study at week 46) were included in the usability population.

PD, pharmacodynamics; PK, pharmacokinetics.