🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT04882098
Active, not recruiting Phase 3

A Study of Guselkumab in Participants With Active Psoriatic Arthritis

NCT04882098 · tracked via the Priya Life Science China tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2021-06-17
Last updated
2026-08-28

Condition(s) studied

Arthritis, Psoriatic

Investigational drug(s) / intervention(s)

GuselkumabPlacebo

Guselkumab: Participants will receive guselkumab as SC injection.

Placebo: Participants will receive matching placebo as SC injection.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (280)

FacilityCityRegionStatus
Rheumatology Associates Birmingham Alabama
Arizona Arthritis and Rheumatology Research PLLC Flagstaff Arizona
Arizona Arthritis & Rheumatology Associates PC Glendale Arizona
Arizona Arthritis & Rheumatology Research, PLLC Tucson Arizona
Advanced Medical Research La Palma California
Rheumatology Center of San Diego San Diego California
Medvin Clinical Research, Inc. Whittier California
Heuer M.D. Research Orlando Florida
The Arthritis Center, Inc. Palm Harbor Florida
Forcare Clinical Research Inc Tampa Florida
Klein And Associates M D P A Hagerstown Maryland
Advanced Rheumatology Okemos Michigan
Arthritis Consultants St Louis Missouri
Glacier View Research Institute Kalispell Montana
NYU Langone Ambulatory Care Brooklyn Heights Brooklyn New York
PMG Research of Salisbury Salisbury North Carolina
STAT Research, Inc. Springboro Ohio
Altoona Center For Clinical Research Duncansville Pennsylvania
Dr. Ramesh Gupta Memphis Tennessee
Austin Regional Clinic Austin Texas
Adriana Pop Moody MD Clinic PA Corpus Christi Texas
Southwest Rheumatology Research LLC Mesquite Texas
Arthritis And Osteoporosis Clinic Waco Texas
The Queen Elizabeth Hospital Adelaide Australia
Southern Clinical Research Hobart Australia
Emeritus Research Melbourne Australia
Eastern Health - Box Hill Hospital Melbourne Australia
Rheumatology Research Unit Sunshine Coast Australia
University Clinical center Republic of Srpska 1 Banja Luka Bosnia and Herzegovina
University Clinical center Republic of Srpska Banja Luka Bosnia and Herzegovina
Health center Gradiska Gradiska Bosnia and Herzegovina
Clinical hospital Mostar Mostar Bosnia and Herzegovina
Clinical Center University of Sarajevo Sarajevo Bosnia and Herzegovina
Medical Center Medconsult-Pleven Pleven Bulgaria
Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv Plovdiv Bulgaria
UMHAT Kaspela 1 Plovdiv Bulgaria
UMHAT Kaspela Plovdiv Bulgaria
MHAT Trimantium Plovdiv Bulgaria
Multiprofile Hospital for Active Treatment Plovdiv Plovdiv Bulgaria
Medical Center Unimed Plovdiv Plovdiv Bulgaria

+ 240 more sites — see the full list on the official registry below.

On this site

📄 Tremfya (guselkumab) drug profile →

More Janssen Research & Development, LLC trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04882098 on ClinicalTrials.gov ↗ ← All trials in China