Clinical Research Studies

Participants who satisfy all inclusion and exclusion criteria will be randomly assigned to one of the following 3 treatment groups in a 7:5:7 ratio using permuted block randomization with stratification defined by a combined factor of baseline radiographic variability, corticosteroid use, number of joints with erosion, and the most recent available C-reactive protein (CRP) value prior to randomization into 4 strata levels (high radiographic variability [HRV], no progression [NP], low to moderate progression [LMP], and rapid progression [RP]). All participants with HRV will be assigned to the HRV stratum, and the rest of participants will be assigned to the other strata based on probability of NP, LMP, and RP. • Group I (n=350): Participants will receive subcutaneous (SC) guselkumab 100 mg at Weeks 0, 4, 12, 20, 28, 36 and 44 and placebo at Weeks 8, 16, 24, 32, 40 and 48 to maintain the blind. • Group II (n=250): Participants will receive SC guselkumab 100 mg at Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48. • Group III (n=350): Participants will receive SC placebo at Weeks 0, 4, 8, 12, 16 and 20, and will cross over at Week 24 to receive SC guselkumab 100 mg at Weeks 24, 28, 32, 36, 40, 44 and 48. At Week 16, all participants in Groups I, II, and III with <20% improvement from baseline in both tender and swollen joint counts will qualify for early escape (EE) and will be allowed to initiate or increase the dose of one of the permitted concomitant medications up to the maximum allowed dose, as selected by the investigator. At Week 48, participants who have not discontinued will be eligible to enter a long-term extension (LTE) for a period of up to approximately two years (ie, Week 48 through Week 156).