Active Not Recruiting
PHASE3
INTERVENTIONAL
NCT04882098
A Study of Guselkumab in Participants With Active Psoriatic Arthritis
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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.
Interventions
Name:
Guselkumab
Type:
DRUG
Description:
Participants will receive guselkumab as SC injection.
Name:
Placebo
Type:
DRUG
Description:
Participants will receive matching placebo as SC injection.
Primary Outcomes
Measure:
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24
TimeFrame:
Week 24
Description:
The ACR 20 Response is defined as greater than or equal to (\>=) 20 percent (%) improvement in swollen joint count (66 joints) and tender joint count (68 joints) and \>=20 percent improvement in 3 of following 5 assessments: participant's assessment of pain using Visual Analog Scale (VAS; 0-100 millimeter \[mm\], 0 mm=no pain and 100 mm=worst possible pain), participant's global assessment of disease activity by using VAS (scale ranges from 0 mm to 100 mm, \[0 mm= very well to 100 mm= very poor\]), physician's global assessment of disease activity using VAS (scale ranges from 0 to 100), \[0 = no arthritis to 100 = extremely active arthritis\], participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and C-reactive protein (CRP).
Trial Information
NCT ID
NCT04882098
Status
Active Not Recruiting
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Janssen Research & Development, LLC
Last Updated
December 15, 2025