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NCT04929210 · ClinicalTrials.gov registry record · Phase 4
A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease
A Phase 4 study of Arthritis, Psoriatic, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 4
- Development phase
- 411
- Enrollment target
- 20
- Study locations
NCT04929210: Active Phase 4 study of Arthritis, Psoriatic, sponsored by Janssen Research & Development.
NCT04929210 is a Phase 4 study of Arthritis, Psoriatic that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 411 participants, below the 551-participant average among 16 other Arthritis, Psoriatic trials with a reported enrollment target (25% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04929210, a Phase 4 study of Arthritis, Psoriatic, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 411 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) axial disease by assessing reduction in axial symptoms and inflammation.
Primary Outcome
BASDAI is a self-assessment tool that consists of 6 questions relating to 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain, enthesitis, qualitative morning stiffness and quantitative morning stiffness. First 5 items were scored on a 10 centimeter (cm) visual analog scale (VAS) ranging from 0 equals to (=) none to 10=very severe. Quantitative morning stiffness was scored on a 10 cm VAS ranging from 0=0 hours to 10=2 or more hours. 2 scores for qualitative and quantitat
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Guselkumab
Study Locations (20)
Arizona
- Arizona Arthritis and Rheumatology Research PLLC - Avondale
- Arizona Arthritis & Rheumatology Research, PLLC - Chandler
- Arizona Arthritis and Rheumatology Research PLLC - Mesa
- Arizona Arthritis Research, PLC. - Phoenix
- Arizona Arthritis and Rheumatology Associates - Sun City
- Southern Arizona VA Healthcare System - Tucson
California
- Kaiser Permanent Medical Center - Fontana
- Newport Huntington Medical Group - Huntington Beach
- University Of California San Diego - La Jolla
- Rheumatology Center of San Diego - San Diego
Florida
- Bay Pines VA Healthcare System - Bay Pines
- Integral Rheumatology And Immunology Specialists - Plantation
- Florida Medical Clinic, P.A. - Zephyrhills
Illinois
- Great Lakes Clinical Trials - Chicago
- OrthoIllinois - Rockford
- Willow Rheumatology and Wellness - Willowbrook
Maryland
- Johns Hopkins Bayview Medical - Baltimore
- Klein And Associates M D P A - Hagerstown
Arkansas
- Unity Health-White County Medical Center - Searcy
Connecticut
- Clinical Research Center of Connecticut - Danbury
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 411 participants |
| Start Date | 2021-08-30 |
| Est. Completion | 2027-04-13 |
| Phase | Phase 4 |
What the registry record for NCT04929210 still lists
NCT04929210 is an interventional study that assigns participants to a tested intervention. The registered 411 participants enrollment target is mid-sized for trials with a published cap, below the 551-participant average among 16 other Arthritis, Psoriatic trials with a reported enrollment target (25% 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.
NCT04929210 names 20 study sites across 7 states, led by Arizona, California, Florida.
Frequently Asked Questions
What is clinical trial NCT04929210 about?
NCT04929210 is a clinical study titled "A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease". The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) axial disease by assessing reduction in axial symptoms and inflammation.
What is the current status of trial NCT04929210?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 411 participants. The study started on 2021-08-30. Estimated completion is 2027-04-13.
What conditions does trial NCT04929210 study?
This clinical trial studies the following conditions: Arthritis, Psoriatic.
What interventions are being tested in trial NCT04929210?
The interventions under investigation include: Placebo (DRUG), Guselkumab (DRUG).
Who is sponsoring clinical trial NCT04929210?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04929210 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04929210's enrollment target sits among peer trials
411 9th of 16 higher than 8 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.
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