duration of study corrected from 60 to 56 weeks with clarifications added for timing (at Week 52/8 weeks after the last dose of study drug) and duration (4 weeks) of the follow-up period; clarifications to Schedule of Assessments footnotes; and administrative changes.

stable dose for MTX therapy allowed in the study changed from 7.5 to 25 mg/week to 10 to 25 mg/week with 7.5 mg/week allowed only in case of intolerance to a higher dose; addition of HBV serology screening criteria for European and Chinese sites; year of birth collected instead of date of birth; addition that vital signs were to be performed more frequently in TP2; addition that all clinical laboratory tests except CRP and IGRA were to be performed by local laboratories instead of central laboratory for Chinese sites; and administrative changes.

inclusion criterion 6 was revised to remove the requirement of previous TNF inhibitor treatment for study entry; and total volume of blood sampling was updated.

correction of Sponsor name; updated Medical Monitors and contact information; number of sites increased to approximately 55 sites; primary endpoint edited: was to be analyzed at 2 time points (Weeks 12 or 24) depending on the regulatory agency for submission and it was also estimated that 598 evaluable subjects completing Week 12 was needed; update of primary efficacy analysis based on change of primary endpoint; sample size re-estimation based on the recommendations of the 3 different agencies for the 2 different time points for the primary endpoint (meta analysis performed for re-estimation); addition of 5-minute window for IV infusion; updated rules for dose adjustment with regard to liver enzymes; allowed topical steroids or NSAIDs during the study; noted that any assessment required at Early Termination that had been performed at 4 weeks of the last study drug dosing did not need to be repeated at the Early Termination Visit in case of early withdrawal and that any scheduled assessment for Follow-Up Visit that had been performed at 8 weeks after the last study drug dosing need not be repeated at the Follow-Up Visit; AE monitoring was continued until 8 weeks after last dose of study drug and only an AE with increasing severity was to be recorded as a separate event; added that microscopy or other quantitative urine test was to be performed if there was any positive clinically significant result in urinalysis dipstick; removal of respiration rate assessment from vital signs and removal of cervical examination from physical examination; and addition of analysis that may be performed to evaluate the effects of COVID-19 per regulatory guidance.

updated statistical analyses and sample size calculations per US FDA comments; clarified blinding details; and addition of separate (ie, outside of the protocol) population PK study.