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NCT Number: NCT05669833

Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients

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.

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Key information

Conditions

Psoriatic Arthritis Arthritis Arthritis, Psoriatic Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Family Arthritis Center, Loxahatchee Groves, Florida, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Psoriatic arthritis meeting CASPAR criteria;
  • Active psoriatic arthritis defined by at least 1 swollen joint;
  • cDAPSA score ≥ 10; See also Exclusion #4 - cDAPSA must be > 14 in patients without psoriasis.
  • 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;
  • 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.
  • 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;
  • 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

  • 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;
  • 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;
  • Use of moderate to high dose glucocorticoids (>10 mg);
  • 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.

  • Currently pregnant or actively trying to conceive.

Treatment and study plan

Guselkumab

Drug

Guselkumab (GUS) subcutaneous injection

Other names: Tremfya

Golimumab

Drug

Golimumab (GOL) subcutaneous injection

Other names: Simponi

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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. 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).

  7. 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).

  8. 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.

  9. 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.

  10. 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.

  11. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Gillespie

CONTACT

[email protected]

(215) 614-1840

Study Coordinator

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Janssen Scientific Affairs, LLC

Registry information

Official study title

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

Acronym: EVOLUTION

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 3, 2023
Registry last updated
Oct 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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