RecruitingPsoriatic Arthritis

Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients

Eligible age

18–80 yrs

Accepts

All genders

Locations

10 states

Healthy volunteers

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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.

Sponsor: University of Pennsylvania

You may qualify if…

✓ 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).

You may not qualify if…

✕ 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.