 Randomization was stratified by participating center and baseline Disease Activity Score, scoring 28 joints DAS28 level 5.1 vs. 5.1. Patients were evaluated every 4 weeks and at each visit a decision on dosage changes was made based on efficacy parameters DAS28 and occurrence of adverse events AEs. Patients received MTXplaceboMTX in climbing dosages. Hydroxychloroquine HCQ was added when remission was not reached with the maximum tolerable dosage MTD of MTXplaceboMTX. If after 12 additional weeks remission was not reached, HCQ was stopped and replaced by standard of care therapy in Group I or placebo therapy was replaced by the corresponding verum resulting in TCZMTX combination therapy in Groups II and III. In case remission was reached, MTXplaceboMTX and TCZplaceboTCZ had to be decreased. Patients were followed for a maximum of 24 months 