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Monoclonal Antibodies

Guselkumab for Psoriatic Arthritis (APEX Trial)

Phase 3
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 one psoriatic plaque of >= 2 centimeter (cm) diameter or nail changes consistent with psoriasis
Have active PsA as defined by: at least 3 swollen joints and 3 tender joints at screening and at baseline; and C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligrams per deciliter (mg/dL) at screening from the central laboratory
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 168 weeks
Awards & highlights

APEX Trial Summary

This trial is testing a new drug for people with psoriatic arthritis to see if it can reduce symptoms.

Who is the study for?
This trial is for people with active psoriatic arthritis who've tried other treatments like DMARDs, apremilast, or NSAIDs without enough relief. They should have symptoms like swollen and tender joints, a certain level of inflammation in their blood, and joint damage visible on X-rays. It's not for those with other inflammatory diseases that could affect results or anyone allergic to the study drug.Check my eligibility
What is being tested?
The trial tests Guselkumab's effectiveness against PsA by comparing it to a placebo. Participants will be randomly assigned to receive either Guselkumab or an inactive substance (placebo) to see if there's a significant improvement in their PsA symptoms.See study design
What are the potential side effects?
Guselkumab may cause side effects such as infections, headaches, injection site reactions (like pain or swelling), and possibly allergic reactions. The exact side effects can vary from person to person.

APEX 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 2cm or nail changes.
Select...
I have Psoriatic Arthritis with at least 3 swollen and 3 tender joints, and my CRP levels are high.
Select...
I have been diagnosed with Psoriatic Arthritis for at least 6 months.
Select...
I have active psoriatic arthritis and treatments like DMARDs or NSAIDs haven't worked.
Select...
I have a type of psoriatic arthritis affecting my joints or spine.

APEX Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 168 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 168 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
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24
Secondary outcome measures
Change From Baseline in Psoriatic Arthritis (PsA) Modified Van Der Heijde-Sharp (vdH-S) Total Score at Week 24
Number of Participants With Change from Baseline in Clinical Laboratory Abnormalities
Number of Participants with AEs Temporally Associated With an Injection-site Reactions
+6 more

Side effects data

From 2020 Phase 4 trial • 1027 Patients • NCT03573323
9%
Injection site reaction
8%
Upper respiratory tract infection
7%
Nasopharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ixekizumab
Guselkumab
Ixekizumab Post-Treatment Follow Up
Guselkumab Post-Treatment Follow Up

APEX Trial Design

3Treatment groups
Experimental Treatment
Group I: Group 3: Placebo Followed by GuselkumabExperimental Treatment2 Interventions
Participants will receive placebo SC and will cross over to receive SC guselkumab. Participants who have not discontinued will be eligible to enter an LTE and will receive guselkumab SC.
Group II: Group 2: GuselkumabExperimental Treatment1 Intervention
Participants will receive guselkumab SC. Participants who have not discontinued will be eligible to enter an LTE and will receive guselkumab SC.
Group III: Group 1: Guselkumab and PlaceboExperimental Treatment2 Interventions
Participants will receive guselkumab and placebo subcutaneously (SC) to maintain the blind. Participants who have not discontinued will be eligible to enter a long-term extension (LTE) and will receive guselkumab and placebo SC. After the study is unblinded to the investigative sites, participants will receive guselkumab and no longer be required to dose with placebo to maintain the blind.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Guselkumab
2015
Completed Phase 4
~5990

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,383,358 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
3,958,955 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: NCT04882098 — Phase 3
Psoriatic Arthritis Research Study Groups: Group 1: Guselkumab and Placebo, Group 3: Placebo Followed by Guselkumab, Group 2: Guselkumab
Psoriatic Arthritis Clinical Trial 2023: Guselkumab Highlights & Side Effects. Trial Name: NCT04882098 — Phase 3
Guselkumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04882098 — Phase 3

Frequently Asked Questions

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

What are the unique elements of this clinical trial?

"As of right now, there are 21 ongoing studies for Guselkumab in 282 cities and 57 countries. The first study was done in 2018 and, sponsored by Janssen Research & Development, LLC, it included 1406 participants. It completed its Phase 2 & 3 drug approval stage. Since 2018, 18280 studies have been conducted."

Answered by AI

Are there any available positions for individuals in this trial?

"The website provides accurate information—this study is still recruiting patients. It was originally posted on June 17th, 2021, and has been edited most recently on November 3rd, 2022. In total, they are looking for 950 patients from 25 different locations."

Answered by AI

Are there any reported dangers associated with Guselkumab?

"There is some evidence backing Guselkumab's efficacy, as well as multiple rounds of data that support its safety; it thus receives a 3 on our Power team's scale."

Answered by AI

Are a lot of hospitals in the United States participating in this clinical trial?

"There are 25 sites conducting this research, like Group De Recherche En Rhumatologie Et Maladies Osseuses in Quebec, Southwest Rheumatology Research LLC in Mesquite, and STAT Research, Inc. in Dayton."

Answered by AI

What are the most similar trials to Guselkumab that have already been completed?

"There are a total of 21 clinical trials for Guselkumab that are currently ongoing. Of these, 7 are in Phase 3. The primary locations for these studies are Milan and Kansas, though there are 2682 total sites running these trials."

Answered by AI

How many total individuals will be a part of this experiment?

"That is correct. The online information from clinicaltrials.gov affirms that this study, which was first advertised on June 17th 2021, is still recruiting patients. A total of 950 people are needed for the 25 different sites."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Arizona Arthritis & Rheumatology Associates PC
Recent research and studies
clinicaltrials.govStudy
A Study of Guselkumab in Participants With Active Psoriatic Arthritis
2021. "A Study of Guselkumab in Participants With Active Psoriatic Arthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04882098.
All > Arthritis > Psoriatic Arthritis
~181 spots leftby Jan 2025
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