The overall reason for the amendment was to include the following changes:The open-label or double-blind treatment period was extended from Week 36 to Week 52. The Golimumab IV dose was changed from 4 milligram per kilogram (mg/kg) IV every 8 weeks with a loading dose to 2 mg/kg IV every 8 weeks with a loading dose. The disease flare Golimumab IV rescue treatment group was removed. The American College of Rheumatology (ACR) 50 response was replaced by a Disease Activity Score in 28 joints (DAS28) good response (as defined by European League Against Rheumatism (EULAR) criteria and calculated using ESR) requirement at Week 16 to determine whether a subject would continue open label treatment or be randomized to receive double-blind treatment. The TB inclusion criterion was also modified to allow for a chest radiograph at screening. Exclusion criteria related to drugs and investigational agents received before the first dose of study agent were modified. Instructions for reporting malfunctions or damage to the autoinjectors/prefilled pens were provided. Changes to the statistical analyses included an update to the treatment failure criteria for the primary analysis, a revision to the Cochran-Mantel-Haenszel (CMH) test to include stratification by ACR 20 criteria, an update to DAS28 response (EULAR response criteria) analyses using C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), an addition of a summary of injection-site reactions for Golimumab by severity, deletion of subgroup analyses to evaluate consistency of safety over time, and a change to the significance level of the 2-sided binomial test from 0.05 to 0.049 to adjust for 1 interim analysis.

The overall reason for the amendment was to include the following changes: Stopping rules were added for participants who had continued severe disease activity [Disease Activity Score in 28 joints(DAS28) greater than (>) 5.2] or diminished treatment effectiveness beginning at the Week 20 visit. The treatment regimen of etanercept or adalimumab for inclusion of participants in the study was clarified. Inclusion criteria for TB were modified. A Data Monitoring Committee (DMC) was added to monitor safety throughout the study. Information pertaining to the use of corticosteroids, Non-steroidal anti-inflammatory drugs (NSAIDs), analgesics, prohibited biologic agents, and prohibited DMARDs/systemic immunosuppressive agents were modified. The number of study sites was increased from 120 to 150 worldwide.

The overall reason for the amendment was to include the following changes: A voluntary, open-label, 24 week study extension period was added. A definition for Disease Activity Score in 28 joints (DAS28) (ESR-based) low disease activity was added. Two additional secondary analyses related to DAS28 greater than or equal to (≥) 3.2 were added and the use of CRP or ESR in the definition for DAS28 remission was clarified.

The overall reason for the amendment was to include the following changes: Testing for HBV infection prior to receiving study agent was added. Evaluations for suspected Tuberculosis (TB) were clarified. Revised exclusion criteria, and other applicable protocol sections, related to treatment with disease modifying antirheumatic drugs (DMARDS)/systemic immunosuppressive agents and intra-articular, intramuscular (IM), or IV corticosteroids were changed to specify the prohibited use (in weeks or months) relative to screening instead of the administration of study agent. Gout was added to the list of excluded inflammatory diseases other than RA. Infraclavicular was changed to supraclavicular regarding location of lymph nodes in exclusion criteria for symptoms of possible lymphoproliferative disease. The description of the assessment and documentation of joints that were replaced before the study was modified to clarify that an entry in the electronic case report form (eCRF) indicating “nonevaluable” for a replaced joint would supersede the blinded value from the independent joint assessment on the joint assessment worksheet. This amendment also specified that Participants who participated in the extension would not be unblinded to their main study treatment assignment at the time of study extension entry.

The overall reason for the amendment was to include the following changes: HBV testing at the next study visit for all Participants who were currently participating in the trial and to use the results to determine continued subject participation in the trial. The definition of a serious adverse event was updated to include the suspected transmission of an infectious agent by a medicinal product per the current definition in Volume 9A of The Rules Governing Medicinal Products in the European Union – Guidelines on Pharmacovigilance for Medicinal Products for Human Use (September 2008).

The overall reason for the amendment was to include the following changes: to add prefilled syringes as an additional method of administering study agent to ensure that Participants would not miss an administration of study drug should autoinjector supplies become limited. The use of corticosteroids in the study was clarified. This amendment also included/corrected text describing when a subject should have been discontinued from the study in the event he/she tested positive for hepatitis B virus (HBV) during the study.