NCT05669833 Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
| NCT ID | NCT05669833 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Pennsylvania |
| Condition | Psoriatic Arthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 63 participants |
| Start Date | 2023-07-14 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 63 participants in total. It began in 2023-07-14 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Alexis Ogdie-Beatty, MD, MSCE
PRINCIPAL INVESTIGATOR
University of Pennsylvania
Frequently Asked Questions
Who can join the NCT05669833 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Psoriatic Arthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05669833 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 63 participants.
Is NCT05669833 currently recruiting?
Yes, NCT05669833 is actively recruiting participants. Contact the research team at sarah.hopkins@pennmedicine.upenn.edu for enrollment information.
Where is the NCT05669833 trial being conducted?
This trial is being conducted at Loxahatchee Groves, United States, Plant City, United States, Riverview, United States, Lilburn, United States and 10 additional locations.
Who is sponsoring the NCT05669833 clinical trial?
NCT05669833 is sponsored by University of Pennsylvania. The principal investigator is Alexis Ogdie-Beatty, MD, MSCE at University of Pennsylvania. The trial plans to enroll 63 participants.