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

Completed · Phase 2 · Has a placebo group

Conditions studied: Arthritis, Psoriatic

In brief

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.

Key facts

Study ID

NCT05071664

Run by

Janssen Research & Development, LLC

People needed

91

Starts

2021-10-25

Expected to finish

2024-08-06

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Arizona Arthritis and Rheumatology Research PLLC 1 — Phoenix, Arizona, United States
• Unity Health-White County Medical Center — Searcy, Arkansas, United States
• HARAC Research Corp — Avon Park, Florida, United States
• Bay Pines VA Healthcare System — Bay Pines, Florida, United States
• Omega Research Consultants — DeBary, Florida, United States
• South Coast Research Center — Miami, Florida, United States
• Advanced Clinical Research of Orlando — Ocoee, Florida, United States
• Millennium Research — Ormond Beach, Florida, United States
• Atlanta Research Center for Rheumatology — Marietta, Georgia, United States
• Great Lakes Center of Rheumatology — Lansing, Michigan, United States
• Clinvest — Springfield, Missouri, United States
• NYU Langone Ambulatory Care Brooklyn Heights — Brooklyn, New York, United States
• NYU School of Medicine — New York, New York, United States
• University of Rochester — Rochester, New York, United States
• Jacobi Medical Center — The Bronx, New York, United States
• STAT Research, Inc. — Vandalia, Ohio, United States
• Trinity Universal Research Associates, LLC — Plano, Texas, United States
• DM Clinical Research — Tomball, Texas, United States
• Swedish Medical Center — Seattle, Washington, United States
• Frederiksberg Hospital — Frederiksberg, Denmark
• Rigshospitalet Glostrup — Glostrup Municipality, Denmark
• Køge Sygehus Region Sjaelland — Køge, Denmark
• Silkeborg Hospital — Silkeborg, Denmark
• Vejle Sygehus — Vejle, Denmark
• Arizona Arthritis and Rheumatology Research PLLC — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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