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NCT04936308 · ClinicalTrials.gov registry record · Phase 3
Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent
A Phase 3 study of Arthritis, Psoriatic, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 3
- Development phase
- 453
- Enrollment target
- 20
- Study locations
NCT04936308: Active Phase 3 study of Arthritis, Psoriatic, sponsored by Janssen Research & Development.
NCT04936308 is a Phase 3 study of Arthritis, Psoriatic that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 453 participants, below the 548-participant average among 16 other Arthritis, Psoriatic trials with a reported enrollment target (17% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04936308, a Phase 3 study of Arthritis, Psoriatic, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 453 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) and/or intolerance to a prior anti-tumor necrosis factor (TNF) by assessing the reduction in signs and symptoms of PsA.
Primary Outcome
ACR 20 response: \>=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=20% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=ex
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Guselkumab
Study Locations (20)
Florida
- Bay Pines VA Healthcare System - Bay Pines
- Clinical Research of West Florida - Clearwater
- Omega Research Consultants - DeBary
- Advanced Clinical Research of Orlando - Ocoee
- Integral Rheumatology And Immunology Specialists - Plantation
- Clinical Research of West Florida 1 - Tampa
- Florida Medical Clinic, P.A. - Zephyrhills
Arizona
- Arizona Arthritis and Rheumatology Research PLLC 2 - Avondale
- Arizona Arthritis and Rheumatology Research PLLC 3 - Flagstaff
- Arizona Arthritis and Rheumatology Research PLLC - Mesa
- Arizona Arthritis and Rheumatology Research PLLC 1 - Phoenix
- Arizona Arthritis and Rheumatology Associates - Sun City
- Southern Arizona VA Healthcare System - Tucson
California
- Newport Huntington Medical Group - Huntington Beach
- Medvin Clinical Research 2 - Thousand Oaks
- Medvin Clinical Research - Tujunga
Alabama
- Arthritis Associates - Mountain Brook
Arkansas
- Unity Health-White County Medical Center - Searcy
Connecticut
- Clinical Research Center of Connecticut - Danbury
Illinois
- Great Lakes Clinical Trials - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 453 participants |
| Start Date | 2021-09-28 |
| Est. Completion | 2026-07-16 |
| Phase | Phase 3 |
What the registry record for NCT04936308 still lists
NCT04936308 is an interventional study that assigns participants to a tested intervention. The registered 453 participants enrollment target is mid-sized for trials with a published cap, below the 548-participant average among 16 other Arthritis, Psoriatic trials with a reported enrollment target (17% lower).
The record links to 1 condition, with Arthritis, Psoriatic appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04936308 names 20 study sites across 7 states, led by Florida, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT04936308 about?
NCT04936308 is a clinical study titled "Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent". The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) and/or intolerance to a prior anti-tumor necrosis factor (TNF) by assessing the reduction in signs and symptoms of PsA.
What is the current status of trial NCT04936308?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 453 participants. The study started on 2021-09-28. Estimated completion is 2026-07-16.
What conditions does trial NCT04936308 study?
This clinical trial studies the following conditions: Arthritis, Psoriatic.
What interventions are being tested in trial NCT04936308?
The interventions under investigation include: Placebo (DRUG), Guselkumab (DRUG).
Who is sponsoring clinical trial NCT04936308?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04936308 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Arthritis, Psoriatic
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04936308's enrollment target sits among peer trials
453 8th of 16 higher than 9 of 16 other Arthritis, Psoriatic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Arthritis, Psoriatic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced Participants With Active Psoriatic Arthritis
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-
A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants
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-
Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response
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-
A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic Arthritis
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-
A Long-term Extension Study of Ustekinumab in Pediatric Participants
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-
A Study of Guselkumab in Participants With Active Psoriatic Arthritis
ACTIVE NOT RECRUITING · Phase 3
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