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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 42 weeks
Awards & highlights

AFFINITY Trial Summary

This trial is testing whether a combination of two drugs is more effective than one of the drugs alone in treating psoriatic arthritis.

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.Check my eligibility
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).See study design
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.

AFFINITY 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...
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.

AFFINITY Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants who Achieve Minimal Disease Activity (MDA) at Week 24
Secondary outcome measures
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
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

AFFINITY 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
~5990
Golimumab
2014
Completed Phase 4
~3480

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,217 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
3,959,814 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

Frequently Asked Questions

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

How many volunteers are actively participating in this clinical research?

"Affirmative. According to clinicaltrials.gov, recruitment for this medical study commenced on October 25th 2021 and is still ongoing as of November 3rd 2022. Approximately 90 patients are needed at 16 distinct sites across the US."

Answered by AI

To which medical ailments is Guselkumab most frequently administered?

"Guselkumab has been proven to help patients with psoriasis, active polyarticular juvenile idiopathic arthritis (pjia), and moderate ulcerative colitis alleviate the symptoms of their condition."

Answered by AI

Are there any North American hospitals currently conducting this clinical experiment?

"This trial is recruiting participants from a range of sites, such as Omega Research Consultants in DeBary, Advanced Clinical Research of Orlando in Ocoee and Unity Health-White County Medical Center in Searcy. Additionally, there are 16 other enrolment locations for this clinical study."

Answered by AI

Are there opportunities for new participants to join this research endeavor?

"Affirmative, the data hosted on clinicaltrials.gov suggest active recruitment is taking place for this trial. It was initially crafted in October 2021 and amended as recently as November 2022 with a view to enlisting 90 subjects from 16 different sites."

Answered by AI

Are there previous experiments involving Guselkumab that can inform our current research?

"Guselkumab's research first started at University of Nebraska Medical Centre in 2007 and the total number of studies conducted is now 18,379. At present there are 33 clinical trials actively recruiting patients from DeBary, Florida and other locations."

Answered by AI

Has Guselkumab been given the go-ahead by the FDA?

"Based on our team's evaluation, Guselkumab received a score of 2 due to preliminary safety data, but no efficacy information has been established yet as this is still a Phase 2 trial."

Answered by AI

Does this clinical trial accept individuals younger than sixty years of age?

"This clinical research is open to individuals who are of legal age and below the retirement threshold."

Answered by AI

What are the eligibility requirements for individuals to take part in this research study?

"This clinical trial is looking to enroll 90 participants, aged 18 - 65 years old and suffering from psoriatic arthritis. The prospective patients must also meet the following qualifications: have a PsA diagnosis for over 6 months prior to intervention; display active symptoms of PsA including swollen/tender joints, distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, asymmetric peripheral arthrities or spondylitis with peripheral arthritis; present plaque psoriasis that measured at least 2 cm in diameter or nail changes consistent with psoriasis; demonstrate an inadequate response (IR) to"

Answered by AI

Who else is applying?

What state do they live in?
Texas
Arizona
How old are they?
18 - 65
What site did they apply to?
DM Clinical Research
Unity Health-White County Medical Center
Arizona Arthritis and Rheumatology Research, PLLC
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Arizona Arthritis and Rheumatology Research, PLLC: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis
2021. "A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05071664.
All > Psoriatic Arthritis
~0 spots leftby May 2024
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