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Monoclonal Antibodies

Guselkumab + Golimumab for Psoriatic Arthritis (AFFINITY Trial)

Phase 2
Waitlist Available
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 an inadequate response (IR) to anti-tumor necrosis factor-alpha (anti-TNF-alpha) therapy, defined as presence of active PsA despite treatment with either 1 or 2 prior anti-TNF-alpha agent(s) and the following: a. Lack of benefit to either 1 or 2 prior anti-TNF-alpha therapies, as documented in the participant history by the treating physician, after at least 12 weeks of etanercept, adalimumab, or certolizumab pegol therapy, or at least 14-weeks of infliximab, or any biosimilar of these 4 therapies. Documented lack of benefit may include inadequate improvement in joint counts, physical function, or disease activity; b. The last dose of anti-TNF-alpha therapy must have occurred greater than 5 half-lives of the drug prior to first study intervention administration (washout period)
Must not have
Has received prior treatment with golimumab or guselkumab or has documented intolerance to prior anti-TNF-alpha therapy in the participant history by the treating physician
Has known intolerance or hypersensitivity to any biologic medication, or known allergies or clinically significant reactions to murine, chimeric, or human proteins, monoclonal antibodies (mAb), or antibody fragments
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 42 weeks

Summary

This trial is testing if a combination of two drugs, guselkumab and golimumab, is more effective than one drug alone for people with psoriatic arthritis who haven't responded to other treatments. Both drugs help reduce inflammation by blocking specific proteins. Guselkumab is the first interleukin (IL)-23 inhibitor approved for the treatment of moderate-to-severe psoriasis.

Who is the study for?
This trial is for people with active psoriatic arthritis who haven't responded well to at least one or two prior treatments with anti-TNF-alpha drugs. Participants should have symptoms like swollen and tender joints, psoriasis plaques, or nail changes. They can't join if they've had more than two anti-TNF-alpha treatments, other inflammatory diseases that could affect results, known allergies to biologic meds, or a history of intolerance to the study drugs.
What is being tested?
The study tests whether combining Guselkumab and Golimumab is effective in treating psoriatic arthritis compared to using Guselkumab alone in those who didn’t respond adequately to previous therapies targeting TNF-alpha (a protein involved in inflammation).
What are the potential side effects?
Potential side effects may include allergic reactions due to proteins used in the medications, infections because these drugs can weaken the immune system's ability to fight germs, injection site reactions such as redness or pain, and possibly others based on individual health conditions.

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...
My PsA didn't improve after 1 or 2 treatments with anti-TNF drugs.
Select...
I have active Psoriatic Arthritis with at least 3 swollen and 3 tender joints.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with golimumab or guselkumab, or I can't tolerate anti-TNF-alpha therapy.
Select...
I am allergic to certain biologic medications or proteins used in treatments.
Select...
I have been treated with more than 2 anti-TNF-alpha medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 42 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 42 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants who Achieve Minimal Disease Activity (MDA) at Week 24
Secondary study objectives
Diabetes Insipidus
Change from Baseline in Short Form Health Survey (SF-36) Physical Component Score (PCS) at Week 24
Percentage of Participants With AEs Leading to Discontinuation of Study Intervention
+12 more

Side effects data

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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group 1: Guselkumab and GolimumabExperimental Treatment2 Interventions
Participants will receive subcutaneous (SC) guselkumab and golimumab.
Group II: Group 2: Guselkumab and PlaceboActive Control2 Interventions
Participants will receive SC guselkumab and placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guselkumab
2015
Completed Phase 4
~6080
Golimumab
2014
Completed Phase 4
~3610

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
IL-23 inhibitors, like Guselkumab, target the interleukin-23 protein, reducing inflammation and immune response in Psoriatic Arthritis (PsA). TNF-alpha inhibitors, such as Golimumab, block the tumor necrosis factor-alpha, decreasing systemic inflammation, pain, and joint damage. These mechanisms are crucial for PsA patients as they directly address the underlying causes of their symptoms, potentially improving disease management and quality of life.
Efficacy and safety of guselkumab in patients with active psoriatic arthritis: a randomised, double-blind, placebo-controlled, phase 2 study.Guselkumab for the treatment of adults with moderate to severe plaque psoriasis.

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
1,007 Previous Clinical Trials
6,402,279 Total Patients Enrolled
2 Trials studying Psoriatic Arthritis
399 Patients Enrolled for Psoriatic Arthritis
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
772 Previous Clinical Trials
3,980,306 Total Patients Enrolled
2 Trials studying Psoriatic Arthritis
399 Patients Enrolled for Psoriatic Arthritis

Media Library

Golimumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05071664 — Phase 2
Psoriatic Arthritis Research Study Groups: Group 1: Guselkumab and Golimumab, Group 2: Guselkumab and Placebo
Psoriatic Arthritis Clinical Trial 2023: Golimumab Highlights & Side Effects. Trial Name: NCT05071664 — Phase 2
Golimumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05071664 — Phase 2
~22 spots leftby Dec 2025