Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients (EVOLUTION)

October 8, 2025 updated by: University of Pennsylvania

Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients: a Pragmatic Trial (EVOLUTION)

The trial is an open-label randomized study that will examine whether switching to a selective IL23 inhibitor (guselkumab) is more effective than switching to a second TNFi (golimumab) among patients with PsA who have an inadequate response to a TNFi.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary aim of the trial will be to determine, among psoriatic arthritis (PsA) patients with an inadequate response (IR) to a tumor necrosis factor inhibitor (TNFi), whether switching to a new mechanism of action (MOA), specifically guselkumab (GUS), a selective interleukin 23 inhibitor (IL23i) targeting the p19 subunit, is more effective than switching to another TNFi. The primary hypothesis of this study is that switching to a new MOA may be more effective than switching to a second TNFi. This will be the first trial to test such a switch in PsA patients. Additionally, the proposed study will address the effectiveness of a new therapy, GUS, in a clinical practice setting among patients who are TNF IR.

Study Type

Interventional

Enrollment (Estimated)

63

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Loxahatchee Groves, Florida, United States, 33470
      • Plant City, Florida, United States, 33563
      • Riverview, Florida, United States, 33569
        • Recruiting
        • Southwest Florida Rheumatology
        • Principal Investigator:
          • Shanmugapriya Reddy, MD
        • Contact:
    • Georgia
      • Lilburn, Georgia, United States, 30047
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • University of Massachusetts Chan Medical School
        • Contact:
        • Principal Investigator:
          • Karen Salomon-Escoto, MD
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
        • Principal Investigator:
          • Ted Mikuls, MD
        • Contact:
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • New York University
        • Principal Investigator:
          • Soumya Reddy, MD
        • Contact:
    • Ohio
      • Blue Ash, Ohio, United States, 45242
      • Wheelersburg, Ohio, United States, 45694
    • Pennsylvania
    • Tennessee
      • Crossville, Tennessee, United States, 38555
        • Recruiting
        • Cumberland Rheumatology
        • Principal Investigator:
          • Sivalingam Kanagasegar, MD
        • Contact:
    • Texas
      • Colleyville, Texas, United States, 76034
        • Recruiting
        • Heritage Rheumatology and Arthritis Care
        • Principal Investigator:
          • Dhiman Basu, MD
        • Contact:
      • El Paso, Texas, United States, 79902
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • University of Utah
        • Principal Investigator:
          • Jessica Walsh, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Psoriatic arthritis meeting CASPAR criteria;
  2. Active psoriatic arthritis defined by at least 1 swollen joint;
  3. cDAPSA score ≥ 10; See also Exclusion #4 - cDAPSA must be > 14 in patients without psoriasis.
  4. Using a TNFi or previously used a single TNFi historically and either never responded or lost response (TNF IR) and planning to switch to a new biologic therapy;
  5. If using an oral small molecule/csDMARD (i.e., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine, or apremilast), must be on a stable dose for 4 weeks and remain on a stable dose during the study; Use of up to two OSM/csDMARDs is allowed.
  6. If using NSAIDs, glucocorticoids (<10 mg daily) or topical medications for psoriasis, must be on a stable dose for 4 weeks prior to Screening/Baseline 1 and remain on a stable dose during the study;
  7. Age 18-80 (patients older than 80 may be more likely to have concomitant osteoarthritis which may make it difficult to assess whether symptoms are related to PsA vs OA).

Exclusion Criteria:

  1. Prior exposure to golimumab or another non-TNFi biologic (IL12/23i, JAKi, an IL17i, or an IL23i); prior exposure to a TYK2i is acceptable, but cannot be used during course of the study;
  2. An adverse event that precludes use of another TNFi (development of drug-induced SLE, allergic reaction, serious infection, heart failure symptoms, demyelination at any point during use of therapy) or any other contraindication or substantial intolerance to a TNFi;
  3. Use of moderate to high dose glucocorticoids (>10 mg);

  4. Already meets the primary endpoint at Baseline; [cDAPSA low disease activity ≤ 14; IGA of psoriasis 0/1] In patients with psoriasis, cDAPSA can be 10-14 IF the Investigator Global Assessment of Psoriasis ≥ 2.

    In patients without psoriasis, cDAPSA must be > 14 to meet eligibility requirements.

  5. Currently pregnant or actively trying to conceive.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Guselkumab 100mg q4w
Guselkumab (GUS) 100mg every 4 weeks
Drug: Guselkumab
Guselkumab (GUS) subcutaneous injection
Other Names:
  • Tremfya
Experimental: Guselkumab 100mg q8w
Guselkumab (GUS) 100mg every 8 weeks
Drug: Guselkumab
Guselkumab (GUS) subcutaneous injection
Other Names:
  • Tremfya
Active Comparator: Golimumab 50mg q4w
Golimumab (GOL) 50mg every 4 weeks
Drug: Golimumab
Golimumab (GOL) subcutaneous injection
Other Names:
  • Simponi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Achievement of cDAPSA low disease activity
Time Frame: 12 Months
Clinical Disease Activity in Psoriatic Arthritis (cDAPSA): a combination score of tender joint count, swollen joint count, patient assessment of pain, and patient global assessment of disease activity. Scale from 0-154 where higher figures indicate worse status. Remission is considered ≤4 and low disease activity >4 to ≤13.
12 Months
Investigator Global Assessment of Psoriasis of Clear or Almost Clear
Time Frame: 12 Months
Investigator global assessment (IGA) of psoriasis. A scale of 0-4 where higher figures indicate worse status. (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe).
12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minimal Disease Activity (MDA) using PSAID-12
Time Frame: 6 and 12 months
Minimal Disease Activity (MDA) defines a satisfactory state of disease activity that includes 5 domains of PsA. 5/7 of the following criteria must be satisfied for MDA: patient global ≤ 2 (0-10), patient pain ≤ 2 (0-10), PSAID-12 <4 (0-10), TJC (Tender Joint Count) ≤ 1, SJC (Swollen Joint Count) ≤ 1, BSA (Body Surface Area) ≤ 3, and Leeds Enthesitis Index ≤ 1.
6 and 12 months
Minimal Disease Activity (MDA) using HAQ-DI
Time Frame: 6 and 12 months
(MDA) Minimal Disease Activity defines a satisfactory state of disease activity that includes 5 domains of PsA. Participant would need to achieve 5/7 of the following criteria: patient global ≤ 2 (0-10), patient pain ≤ 2 (0-10), HAQ-DI (Health Assessment Questionnaire Disability Index) < 0.5 (0-3), TJC (Tender Joint Count) ≤ 1, SJC (Swollen Joint Count) ≤ 1, BSA (Body Surface Area) ≤ 3, and Leeds Enthesitis Index ≤ 1.
6 and 12 months
Change in PSAID-12
Time Frame: 6 and 12 months
Psoriatic Arthritis Impact of Disease Questionnaire 12-item questionnaire (PSAID-12) Survey. The range of the final PsAID-12 value is 0-10 where higher figures indicate worse status. Negative changes from baseline indicate improvement in disease activity.
6 and 12 months
PSAID-12 < 4
Time Frame: 6 and 12 months
Psoriatic Arthritis Impact of Disease Questionnaire 12-item questionnaire (PSAID-12) Survey. The range of the final PsAID-12 value is 0-10 where higher figures indicate worse status.
6 and 12 months
Change in DLQI
Time Frame: 6 and 12 months
Dermatology Life Quality Index (DLQI) is a measure of skin disease activity. Calculated score of 0-30 where higher figures indicate worse status.Negative changes from baseline indicate improvement in disease activity.
6 and 12 months
IGA Among Patients with BSA > 3% at Baseline
Time Frame: 6 and 12 months
Investigator global assessment (IGA) of psoriasis among patients with BSA (Body Surface Area) >3% at baseline. A scale of 0-4 where higher figures indicate worse status. (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe).
6 and 12 months
IGA Among Patients with IGA ≥ 2 at Baseline
Time Frame: 6 and 12 months
Investigator global assessment (IGA) of psoriasis among patients with IGA of 2 or more (≥ 2) at baseline. A scale of 0-4 where higher figures indicate worse status. (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe).
6 and 12 months
Change in Promis Fatigue
Time Frame: 6 and 12 Months
Promis Fatigue is a measure of fatigue with a score from 8-40 where higher figures indicate worse status. A negative change indicates less overall fatigue.
6 and 12 Months
Resolution of Dactylitis
Time Frame: 6 and 12 Months
Dactylitis is assessed using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. These results are summed to produce a final score ranging from 0 to 20. A higher score indicates more severe dactylitis. Resolution of dactylitis is defined as a dactylitis score of 0 with a baseline dactylitis score >0.
6 and 12 Months
Resolution of Enthesitis
Time Frame: 6 and 12 Months
Enthesitis is assessed using the Leeds Enthesitis Index (LEI). This measure includes the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The total LEI score of 0-6 is based on evaluating each of these six sites as 0 or 1 based on the absence or presence of pain/tenderness. Resolution of enthesitis is defined as a enthesitis score of 0 with a baseline enthesitis score >0.
6 and 12 Months
Change in BASDAI
Time Frame: 6 and 12 Months
Change in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) among patients with axial disease. The BASDAI sum score ranges from 0 to 10 and higher values indicate more active disease. Negative changes from baseline indicate improvement in disease activity.
6 and 12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

Janssen Scientific Affairs, LLC

Investigators

  • Principal Investigator: Alexis Ogdie-Beatty, MD, MSCE, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2023

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

December 20, 2022

First Submitted That Met QC Criteria

December 20, 2022

First Posted (Actual)

January 3, 2023

Study Record Updates

Last Update Posted (Estimated)

October 9, 2025

Last Update Submitted That Met QC Criteria

October 8, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNTO1959PSA3006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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