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Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients

RecruitingPhase 3

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

Who can join

Ages 18 to 80 · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: University of Pennsylvania · Participants: 63 · Started: Jul 14, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05669833

Locations in the U.S.

FloridaFamily Arthritis Center, Loxahatchee Groves
Healing Rheumatology, Plant City
Southwest Florida Rheumatology, Riverview
GeorgiaParris and Associates, Lilburn
MassachusettsUniversity of Massachusetts Chan Medical School, Worcester
NebraskaUniversity of Nebraska Medical Center, Omaha
New YorkNew York University, New York
OhioCincy Arthritis, Blue Ash
Southern Ohio Rheumatology, Wheelersburg
PennsylvaniaHospital at the University of Pennsylvania, Philadelphia
TennesseeCumberland Rheumatology, Crossville
TexasHeritage Rheumatology and Arthritis Care, Colleyville
Texas Arthritis Center, El Paso
UtahUniversity of Utah, Salt Lake City

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.