Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients: a Pragmatic Trial (EVOLUTION)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 80 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this 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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official 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.
Study sites (14)
FL
- Family Arthritis Center · Loxahatchee Groves, FL 33470Veronika Solomon · Study contact · veronika.s@illumination.healthHoward Busch, DO · Principal investigatorMore trials in Loxahatchee Groves
- Healing Rheumatology · Plant City, FL 33563Veronika Solomon · Study contact · veronika.s@illumination.healthGina Prakash, MD · Principal investigatorMore trials in Plant City
- Southwest Florida Rheumatology · Riverview, FL 33569Veronika Solomon · Study contact · veronika.s@illumination.healthShanmugapriya Reddy, MD · Principal investigatorMore trials in Riverview
GA
- Parris and Associates · Lilburn, GA 30047Veronika Solomon · Study contact · veronika.s@illumination.healthGlenn Parris, MD · Principal investigatorMore trials in Lilburn
MA
- University of Massachusetts Chan Medical School · Worcester, MA 01655Study Coordinator · Study contact · 774-455-3528 · chelsea.boateng@umassmed.eduKaren Salomon-Escoto, MD · Principal investigatorMore trials in Worcester
NE
- University of Nebraska Medical Center · Omaha, NE 68198Study Coordinator · Study contact · bridget.kramer@unmc.eduTed Mikuls, MD · Principal investigatorMore trials in Omaha
NY
- New York University · New York, NY 10016Study Coordinator · Study contact · 646-501-7379 · claudine.davis@nyulangone.orgSoumya Reddy, MD · Principal investigatorMore trials in New York
OH
- Cincy Arthritis · Blue Ash, OH 45242Veronika Solomon · Study contact · veronika.s@illumination.healthTara Adhikari, MD · Principal investigatorMore trials in Blue Ash
- Southern Ohio Rheumatology · Wheelersburg, OH 45694Veronika Solomon · Study contact · veronika.s@illumination.healthRajesh Kataria, MD · Principal investigatorMore trials in Wheelersburg
PA
- Hospital at the University of Pennsylvania · Philadelphia, PA 19104Sarah Gillespie, MS · Study contact · 215-614-1840 · sarah.hopkins@pennmedicine.upenn.edu · Study contact · spaprogram@pennmedicine.upenn.eduAlexis Ogdie-Beatty, MD, MSCE · Principal investigatorMore trials in Philadelphia
TN
- Cumberland Rheumatology · Crossville, TN 38555Veronika Solomon · Study contact · veronika.s@illumination.healthSivalingam Kanagasegar, MD · Principal investigatorMore trials in Crossville
TX
- Heritage Rheumatology and Arthritis Care · Colleyville, TX 76034Veronika Solomon · Study contact · veronika.s@illumination.healthDhiman Basu, MD · Principal investigatorMore trials in Colleyville
- Texas Arthritis Center · El Paso, TX 79902Veronika Solomon · Study contact · veronika.s@illumination.healthSanjay Chabra, MD · Principal investigatorMore trials in El Paso
UT
- University of Utah · Salt Lake City, UT 84132Study Coordinator · Study contact · 801-585-0797 · jessica.gonzalez@hsc.utah.eduJessica Walsh, MD · Principal investigatorMore trials in Salt Lake City