A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease
Condition(s) studied
Investigational drug(s) / intervention(s)
Guselkumab: Guselkumab will be administered as subcutaneous injection.
Placebo: Matching placebo will be administered as subcutaneous injection.
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.
Eligibility
Primary outcome measure(s)
- Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Week 24 — Baseline and Week 24
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 quantitative morning stiffness were averaged, and total BASDAI score was average of the 5 scores of each symptom, ranging from 0 (none) to 10 (very severe). Higher scores indicate greater disease severity.
Trial sites (242)
| Facility | City | Region | Status |
|---|---|---|---|
| Arizona Arthritis and Rheumatology Research PLLC 1 | Avondale | Arizona | |
| Arizona Arthritis & Rheumatology Research, PLLC | Chandler | Arizona | |
| Arizona Arthritis and Rheumatology Research PLLC | Mesa | Arizona | |
| Arizona Arthritis Research, PLC. | Phoenix | Arizona | |
| Arizona Arthritis and Rheumatology Associates | Sun City | Arizona | |
| Southern Arizona VA Healthcare System | Tucson | Arizona | |
| Unity Health-White County Medical Center | Searcy | Arkansas | |
| Kaiser Permanent Medical Center | Fontana | California | |
| Newport Huntington Medical Group | Huntington Beach | California | |
| University Of California San Diego | La Jolla | California | |
| Rheumatology Center of San Diego | San Diego | California | |
| Clinical Research Center of Connecticut | Danbury | Connecticut | |
| Bay Pines VA Healthcare System | Bay Pines | Florida | |
| Integral Rheumatology And Immunology Specialists | Plantation | Florida | |
| Florida Medical Clinic, P.A. | Zephyrhills | Florida | |
| Great Lakes Clinical Trials | Chicago | Illinois | |
| OrthoIllinois | Rockford | Illinois | |
| Willow Rheumatology and Wellness | Willowbrook | Illinois | |
| Johns Hopkins Bayview Medical | Baltimore | Maryland | |
| Klein And Associates M D P A | Hagerstown | Maryland | |
| Clinical Research Institute of Michigan, LLC | Saint Clair Shores | Michigan | |
| St. Paul Rheumatology P A | Eagan | Minnesota | |
| Kansas City Physician Partners | Kansas City | Missouri | |
| Clinvest | Springfield | Missouri | |
| STAT Research, Inc. | Vandalia | Ohio | |
| OHSU Rheumatology Clinic, Marquam Hill | Portland | Oregon | |
| Amarillo Center for Clinical Research | Amarillo | Texas | |
| Austin Regional Clinic | Austin | Texas | |
| Precision Comprehensive Clinical Research Solutions | Colleyville | Texas | |
| Adriana Pop Moody MD Clinic PA | Corpus Christi | Texas | |
| AARA Clinical Research Lone Star Arthritis and Rheumatology 1 | Fort Worth | Texas | |
| UT Physicians Center for Autoimmunity | Houston | Texas | |
| AARA Clinical Research Lone Star Arthritis and Rheumatology | Irving | Texas | |
| West Texas Clinical Research | Lubbock | Texas | |
| Southwest Rheumatology Research LLC | Mesquite | Texas | |
| Epic Medical Research | Red Oak | Texas | |
| DM Clinical Research | Tomball | Texas | |
| Swedish Medical Center | Seattle | Washington | |
| Cosultorios Reumatologógicos Pampa | Buenos Aires | Argentina | |
| Consultorios Médicos Dr. Catalán Pellet | Buenos Aires | Argentina |
+ 202 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 Spain
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 NCT04929210 on ClinicalTrials.gov ↗ ← All trials in Spain