NCT05669833

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at below P25 for phase_3

Timeline
5mo left

Started Jul 2023

Typical duration for phase_3

Geographic Reach
1 country

14 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Jul 2023Oct 2026

First Submitted

Initial submission to the registry

December 20, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 3, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

July 14, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

October 9, 2025

Status Verified

October 1, 2025

Enrollment Period

3.2 years

First QC Date

December 20, 2022

Last Update Submit

October 8, 2025

Conditions

Psoriatic Arthritis

Keywords

Psoriatic ArthritisPsA

Outcome Measures

Primary Outcomes (2)

  • Achievement of cDAPSA low disease activity

    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

    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 Outcomes (11)

  • Minimal Disease Activity (MDA) using PSAID-12

    6 and 12 months

  • Minimal Disease Activity (MDA) using HAQ-DI

    6 and 12 months

  • Change in PSAID-12

    6 and 12 months

  • PSAID-12 < 4

    6 and 12 months

  • Change in DLQI

    6 and 12 months

  • +6 more secondary outcomes

Study Arms (3)

Guselkumab 100mg q4w

EXPERIMENTAL

Guselkumab (GUS) 100mg every 4 weeks

Drug: Guselkumab

Guselkumab 100mg q8w

EXPERIMENTAL

Guselkumab (GUS) 100mg every 8 weeks

Drug: Guselkumab

Golimumab 50mg q4w

ACTIVE COMPARATOR

Golimumab (GOL) 50mg every 4 weeks

Drug: Golimumab

Interventions

GuselkumabDRUG

Guselkumab (GUS) subcutaneous injection

Also known as: Tremfya
Guselkumab 100mg q4wGuselkumab 100mg q8w
GolimumabDRUG

Golimumab (GOL) subcutaneous injection

Also known as: Simponi
Golimumab 50mg q4w

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Psoriatic arthritis meeting CASPAR criteria;
  • Active psoriatic arthritis defined by at least 1 swollen joint;
  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Family Arthritis Center

Loxahatchee Groves, Florida, 33470, United States

RECRUITING

Healing Rheumatology

Plant City, Florida, 33563, United States

RECRUITING

Southwest Florida Rheumatology

Riverview, Florida, 33569, United States

RECRUITING

Parris and Associates

Lilburn, Georgia, 30047, United States

RECRUITING

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01655, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

New York University

New York, New York, 10016, United States

RECRUITING

Cincy Arthritis

Blue Ash, Ohio, 45242, United States

RECRUITING

Southern Ohio Rheumatology

Wheelersburg, Ohio, 45694, United States

RECRUITING

Hospital at the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Cumberland Rheumatology

Crossville, Tennessee, 38555, United States

RECRUITING

Heritage Rheumatology and Arthritis Care

Colleyville, Texas, 76034, United States

RECRUITING

Texas Arthritis Center

El Paso, Texas, 79902, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84132, United States

RECRUITING

Related Publications (1)

  • Ogdie A, Reddy SM, Gillespie SH, Husni ME, Scher JU, Salomon-Escoto K, Kay J, Luedders BA, Curtis JR, Shields AJS, Chakravarty SD, Gong C, Walsh JA. Guselkumab versus golimumab in patients with active psoriatic arthritis and inadequate response to an initial tumor necrosis factor inhibitor: study protocol for EVOLUTION, a pragmatic, phase 3b, open-label, randomized, controlled effectiveness trial. Trials. 2025 Mar 19;26(1):96. doi: 10.1186/s13063-025-08777-y.

    PMID: 40102973DERIVED

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

guselkumabgolimumab

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Alexis Ogdie-Beatty, MD, MSCE

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Gillespie

CONTACT

(215) 614-1840sarah.hopkins@pennmedicine.upenn.edu

Study Coordinator

CONTACT

SpAProgram@pennmedicine.upenn.edu

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2022

First Posted

January 3, 2023

Study Start

July 14, 2023

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

October 9, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(14)