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Monoclonal Antibodies

Guselkumab for Psoriatic Arthritis (STAR Trial)

Phase 4
Recruiting
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have active plaque psoriasis, with at least 1 psoriatic plaque of >= 2 centimeter (cm) diameter and/or nail changes consistent with psoriasis, or documented history of plaque psoriasis
Have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4, and have a spinal pain score (on a visual analog scale [VAS]) of at least 4
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 weeks
Awards & highlights

STAR Trial Summary

This trial will study whether the drug guselkumab can reduce symptoms and inflammation in people with psoriatic arthritis that affects the spine.

Who is the study for?
This trial is for individuals with active psoriatic arthritis axial disease, diagnosed at least 6 months ago. Participants must have at least 3 swollen and tender joints, elevated CRP levels, MRI-confirmed PsA axial disease, a BASDAI score of ≥4, spinal pain VAS score of ≥4, and may have plaque psoriasis or nail changes. Those who've had biologic treatments or suffer from other inflammatory diseases like RA or lupus can't join.Check my eligibility
What is being tested?
The study tests the effectiveness of Guselkumab in reducing symptoms and inflammation in patients with PsA axial disease compared to a placebo. Patients will receive either Guselkumab or an inactive substance (placebo) through subcutaneous injections to see if there's an improvement in their condition.See study design
What are the potential side effects?
Potential side effects of Guselkumab include allergic reactions, injection site reactions such as redness and swelling, upper respiratory infections due to immune system suppression by the drug, headache and fatigue. The exact side effects experienced can vary from person to person.

STAR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have active psoriasis with a plaque larger than 2 cm or nail changes.
Select...
My back pain and stiffness are severe, scoring at least 4 out of 10.
Select...
I have PsA with swelling and tenderness in at least 3 joints and high CRP levels despite previous treatments.
Select...
I have been diagnosed with psoriatic arthritis for at least 6 months.
Select...
My MRI shows Psoriatic Arthritis in my spine or sacroiliac joints.

STAR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Week 24
Secondary outcome measures
Change from Baseline in Ankylosing Spondylitis Disease Activity Score-C-Reactive Protein (ASDAS-CRP) at Week 24
Change from Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Week 24
Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 24
+16 more

Side effects data

From 2020 Phase 4 trial • 1027 Patients • NCT03573323
1%
Upper respiratory tract infection
1%
Nasopharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ixekizumab Post-Treatment Follow Up
Guselkumab Post-Treatment Follow Up
Ixekizumab
Guselkumab

STAR Trial Design

3Treatment groups
Experimental Treatment
Group I: Group 3: Placebo followed by GuselkumabExperimental Treatment2 Interventions
Participants will receive matching placebo and will cross over to receive guselkumab SC.
Group II: Group 2: GuselkumabExperimental Treatment1 Intervention
Participants will receive guselkumab SC.
Group III: Group 1: Guselkumab and PlaceboExperimental Treatment2 Interventions
Participants will receive guselkumab and matching placebo subcutaneously (SC) to maintain the blind.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guselkumab
2015
Completed Phase 4
~5970
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
974 Previous Clinical Trials
6,383,885 Total Patients Enrolled
2 Trials studying Psoriatic Arthritis
399 Patients Enrolled for Psoriatic Arthritis
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,504 Total Patients Enrolled
2 Trials studying Psoriatic Arthritis
399 Patients Enrolled for Psoriatic Arthritis

Media Library

Guselkumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04929210 — Phase 4
Psoriatic Arthritis Research Study Groups: Group 1: Guselkumab and Placebo, Group 2: Guselkumab, Group 3: Placebo followed by Guselkumab
Psoriatic Arthritis Clinical Trial 2023: Guselkumab Highlights & Side Effects. Trial Name: NCT04929210 — Phase 4
Guselkumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04929210 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many sites are hosting this investigatory endeavor?

"A variety of Kaiser Permanente hospitals, East Bay Rheumatology Medical Groups, and GCP Clinical Research facilities across 44 locations are currently participating in the recruitment process for this trial. Notable sites include Irvine, Florida; San Leandro, Nevada; and Tampa, Arizona."

Answered by AI

Has Guselkumab secured regulatory approval from the FDA?

"Guselkumab has already been approved, so it was given the highest possible rating of 3 based on its Phase 4 status."

Answered by AI

Is there precedent for this type of clinical inquiry?

"Janssen Research & Development, LLC initiated the first investigation into guselkumab in 2018. Following that initial trial involving 1,406 participants and subsequent Phase 2/3 approval, 19 active trials are ongoing spanning 287 cities across 57 different countries worldwide."

Answered by AI

Is enrollment for this research study still open?

"According to clinicaltrials.gov, this research study is actively recruiting participants. The trial was first published on August 30th 2021 and its most recent update occurred December 1st 2022."

Answered by AI

How many participants are currently involved in this clinical trial?

"In order to execute this investigation, 405 suitable participants are needed. Janssen Research & Development, LLC will be the primary sponsor and administer the trial from multiple sites including Kaiser Permanente in Irvine, Florida and East Bay Rheumatology Medical Group in San Leandro, Nevada."

Answered by AI

What further research has been done concerning Guselkumab's effectiveness?

"Currently, 19 clinical trials related to Guselkumab are being conducted. Of those studies, seven have reached Phase 3 of the trial process. Milan and Kansas house most of these tests; however, there are over 2,700 additional sites where patients can access them."

Answered by AI
~126 spots leftby Jun 2025