A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis

• Status: Not yet recruiting
• Trial end date: 2023-02-17
• Target enrollment: 0
• Participant gender: All

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 a prior anti-tumor necrosis factor-alpha (anti-TNF-alpha) therapy by assessing clinical response compared with guselkumab monotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Golimumab

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: at least 3 swollen joints and at least 3 tender joints at screening and at baseline; and high-sensitivity C-reactive protein (hsCRP) >= 0.3 milligrams per deciliter (mg/dL) at screening from the central laboratory

• 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 1 anti-tumor necrosis factor-alpha (anti-TNF-alpha) therapy, defined as presence of active PsA despite previous treatment with only 1 prior anti-TNF-alpha agent and the following: a. Lack of benefit to 1 prior anti-TNF-alpha therapy, as documented in the participant history by the treating physician, after at least 12 weeks of etanercept, adalimumab, 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 screening visit (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 1 prior anti-TNF-alpha agent (or biosimilars)

• Positive human immunodeficiency virus (HIV) antibody test