Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients

Description

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.

Conditions

Psoriatic Arthritis

Study Overview

Study Details

Study overview

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.

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

Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients

Condition
Psoriatic Arthritis
Intervention / Treatment

-

Contacts and Locations

Loxahatchee Groves

Family Arthritis Center, Loxahatchee Groves, Florida, United States, 33470

Plant City

Healing Rheumatology, Plant City, Florida, United States, 33563

Riverview

Southwest Florida Rheumatology, Riverview, Florida, United States, 33569

Lilburn

Parris and Associates, Lilburn, Georgia, United States, 30047

Worcester

University of Massachusetts Chan Medical School, Worcester, Massachusetts, United States, 01655

Omaha

University of Nebraska Medical Center, Omaha, Nebraska, United States, 68198

New York

New York University, New York, New York, United States, 10016

Blue Ash

Cincy Arthritis, Blue Ash, Ohio, United States, 45242

Wheelersburg

Southern Ohio Rheumatology, Wheelersburg, Ohio, United States, 45694

Philadelphia

Hospital at the University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • 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.
  • 5. Currently pregnant or actively trying to conceive.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Pennsylvania,

Alexis Ogdie-Beatty, MD, MSCE, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

2026-05