a study of guselkumab and golimumab combination therapy in participants with active psoriatic arthritis

Conditions: Arthritis, Psoriatic

Summary: the purpose of this study is to evaluate the efficacy of guselkumab plus golimumab combination treatment in participants with active psoriatic arthritis (psa) and inadequate response (ir) to prior anti-tumor necrosis factor-alpha (anti-tnf-alpha) therapies by assessing clinical response compared with guselkumab monotherapy.

psa is a chronic inflammatory multi-faceted disease that impacts the peripheral and axial joints, soft tissues, and skin. guselkumab is a fully human monoclonal antibody (mab) directed against the p19 subunit of interleukin (il)-23, blocks the binding of extracellular il-23 to the cell surface il-23 receptor, inhibiting il-23 specific intracellular signaling, subsequent activation, and cytokine production. golimumab is a fully human anti-tnf-alpha mab that binds to tnf-alpha with high affinity, prevents binding to its receptors, thereby inhibiting the biological activity of tnf-alpha and resulting in limited production or activity of inflammatory cytokines, thereby providing therapeutic benefit in various chronic inflammatory disorders, including psa. this study will consist of a screening phase (up to 6 weeks), double-blind phase from weeks 0 to 24 which includes the active treatment phase and the primary efficacy visit (week 24), and safety follow-up phase from week 24 to week 36. key safety assessments will include adverse events (aes), clinical laboratory safety tests (hematology and chemistry), vital signs, monitoring for injection-site and hypersensitivity reactions, and early detection of active tuberculosis (tb). the total duration of the study is up to 42 weeks.

Eligibility criteria:
inclusion criteria: * have a diagnosis of psoriatic arthritis (psa) for greater than or equal to (\>=) 6 months prior to the first administration of study intervention and meet classification criteria for psa (caspar) criteria at screening * have active psa as defined by having at least 3 swollen joints and at least 3 tender joints at screening and at baseline * have at least 1 of the following psa subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis * have active plaque psoriasis, with at least one psoriatic plaque of \>=2 centimeter (cm) diameter or nail changes consistent with psoriasis * have an inadequate response (ir) to anti-tumor necrosis factor-alpha (anti-tnf-alpha) therapy, defined as presence of active psa despite treatment with either 1 or 2 prior anti-tnf-alpha agent(s) and the following: a. lack of benefit to either 1 or 2 prior anti-tnf-alpha therapies, as documented in the participant history by the treating physician, after at least 12 weeks of etanercept, adalimumab, or certolizumab pegol therapy, or at least 14-weeks of infliximab, or any biosimilar of these 4 therapies. documented lack of benefit may include inadequate improvement in joint counts, physical function, or disease activity; b. the last dose of anti-tnf-alpha therapy must have occurred greater than 5 half-lives of the drug prior to first study intervention administration (washout period) exclusion criteria: * has other inflammatory diseases that might confound the evaluations of benefit of guselkumab and/or golimumab therapy, including but not limited to rheumatoid arthritis (ra), ankylosing spondylitis (as), nonradiographic axial spondyloarthritis (nr axspa), systemic lupus erythematosus, or lyme disease * has known intolerance or hypersensitivity to any biologic medication, or known allergies or clinically significant reactions to murine, chimeric, or human proteins, monoclonal antibodies (mab), or antibody fragments * has received prior treatment with golimumab or guselkumab or has documented intolerance to prior anti-tnf-alpha therapy in the participant history by the treating physician * has received more than 2 prior anti-tnf-alpha agents (or biosimilars) * positive human immunodeficiency virus (hiv) antibody test