A Study of Guselkumab in Participants With Active Psoriatic Arthritis
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24 — At Week 24
ACR 20 response: \>=20% improvement from baseline (bl) in both swollen (66 joints), tender (68 joints) joint count, \>=20% improvement from bl in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100mm, 0=no pain, 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100mm, 0=excellent, 100=poor), physician's global assessment of disease activity (VAS; 0-100mm, 0=no arthritis activity,100=extremely active arthritis), HAQ-DI (questionnaire assessing 8 functional areas; 0-3, 0=no difficulty, 3=inability to perform task in area), and CRP. Natural Disaster (ND)-site inaccessible due to COVID-19. Major Disruption (MD)-disruption involving Ukraine and neighboring countries/territories. Intercurrent event (ICE) handling: Composite-discontinue study drug not due to ND/MD, initiate/increase DMARD/oral corticosteroid, initiate prohibited PsA treatment; Hypothetical-discontinue/severe noncompliance of study drug due to ND/MD.
Trial sites (280)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 South Korea
Other trials for the same condition
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 South Korea