Major changes included: included all known potential risks associated with adalimumab; allowed for the inclusion of subjects that may have short-term MTX dose decrease or withdrawal for various reasons during the required prior MTX 15 mg ew course of up to 36-week duration; applied a stricter inclusion criterion to increase safety of subjects taking MTX; extended the screening window in certain circumstances; updated rescreening procedures for clarity; updated the contraception recommendation; included HIV testing for subjects that may be at risk for HIV infection; removed scanning for the presence of erosions as methodologically not sufficiently standardized in PsA; revised TB screening procedures; specified subjects that develop TB or any other serious or opportunistic infection must discontinue study treatment and ensure appropriate subject discontinuation in alignment with risks associated with study drug; clarified the reference document used for SUSAR reporting in the EU countries for adalimumab will be the most current version of SmPC; specified that substantial amendments must be reviewed and approved by the competent authority.

Updated safety information to refer to SmPC or prescribing information; updated inclusion criteria to: remove upper limit of 36 weeks for prior MTX 15 mg ew use; updated inclusion criteria to change the timepoint from Screening to Baseline as Baseline is the standard time point prior to and for certain time periods stable doses of oral corticosteroids and csDMARDS are required; change required stability period of oral corticosteroids to 1 week prior to Baseline; change the required stability period of NSAID and paracetamol dosing to 1 week prior to Baseline and clarify dose of paracetamol; require 4 week washout of leflunomide prior to Baseline and prohibited medication to include leflunomide; updated exclusion criteria to: change time point from Screening to Baseline as Baseline is the standard to evaluate whether participant fulfilled appropriate time period of prohibited corticosteroids, joint surgeries, phototherapy, psoriasis therapy, vaccinations, drug or alcohol abuse, infections or anti-infectives, and joint infections for randomization into the study; allow history of fibromyalgia at Baseline while still excluding active fibromyalgia; added exclusion of apremilast and janus kinase inhibitors within 4 weeks of Baseline; added requirement for participants taking tramadol or equivalent opioids and/or non-opioid analgesics and narcotics in fixed combination with acetaminophen be at a stable dose for at least 1 week prior to Baseline; allowed use of NSAIDs and paracetamol at a stable dose during study from 1 week prior to baseline visit and, if used for a reason other than PsA, also on an as-needed basis if used for the same reason and same dose each time; allowed use of tramadol or equivalent opioids and/or non-opioid analgesics and narcotics in fixed combination with acetaminophen at a stable dose during study; prohibited joint surgeries during study; clarified CASPAR criteria to be assessed at Screening; added joint surgeries to reasons for discontinuation