A Study of Guselkumab in Participants With Active Psoriatic Arthritis

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Arthritis, Psoriatic

In brief

The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

Key facts

Study ID

NCT04882098

Run by

Janssen Research & Development, LLC

People needed

1054

Starts

2021-06-17

Expected to finish

2027-10-05

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have active psoriatic arthritis (PsA) despite previous non-biologic disease-modifying antirheumatic drug (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy
• Have a diagnosis of PsA for at least 6 months before the first administration of study agent and meet Classification criteria for Psoriatic Arthritis (CASPAR) at screening
• Have active PsA as defined by: at least 3 swollen joints and 3 tender joints at screening and at baseline; and C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligrams per deciliter (mg/dL) at screening from the central laboratory
• Have >= 2 joints with erosions on baseline radiographs of the hands and feet as determined by central read
• Have at least one 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

You may not qualify if…

• Has known allergies, hypersensitivity, or intolerance to study intervention or its excipients
• Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), axial spondyloarthritis (AS)/non-radiographic axial spondyloarthritis (nr-axSpA), systemic lupus erythematosus, or Lyme disease
• Has previously received any biologic treatment
• Has ever received tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other Janus kinase (JAK) inhibitor
• Has received any systemic immunosuppressants (example, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study intervention

Where it is running

• Arizona Arthritis and Rheumatology Research PLLC — Flagstaff, Arizona, United States
• Arizona Arthritis & Rheumatology Associates PC — Glendale, Arizona, United States
• Arizona Arthritis & Rheumatology Research, PLLC — Tucson, Arizona, United States
• Advanced Medical Research — La Palma, California, United States
• Rheumatology Center of San Diego — San Diego, California, United States
• Medvin Clinical Research, Inc. — Whittier, California, United States
• Heuer M.D. Research — Orlando, Florida, United States
• The Arthritis Center, Inc. — Palm Harbor, Florida, United States
• Forcare Clinical Research Inc — Tampa, Florida, United States
• Klein And Associates M D P A — Hagerstown, Maryland, United States
• Advanced Rheumatology — Okemos, Michigan, United States
• Arthritis Consultants — St Louis, Missouri, United States
• Glacier View Research Institute — Kalispell, Montana, United States
• NYU Langone Ambulatory Care Brooklyn Heights — Brooklyn, New York, United States
• PMG Research of Salisbury — Salisbury, North Carolina, United States
• STAT Research, Inc. — Springboro, Ohio, United States
• Altoona Center For Clinical Research — Duncansville, Pennsylvania, United States
• Dr. Ramesh Gupta — Memphis, Tennessee, United States
• Austin Regional Clinic — Austin, Texas, United States
• Adriana Pop Moody MD Clinic PA — Corpus Christi, Texas, United States
• Southwest Rheumatology Research LLC — Mesquite, Texas, United States
• Arthritis And Osteoporosis Clinic — Waco, Texas, United States
• The Queen Elizabeth Hospital — Adelaide, Australia
• Southern Clinical Research — Hobart, Australia
• Rheumatology Associates — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.