Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
Recruiting · NCT05669833 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Pennsylvania
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Psoriatic arthritis meeting CASPAR criteria;
- Active psoriatic arthritis defined by at least 1 swollen joint;
- cDAPSA score ≥ 10; See also Exclusion #4 - cDAPSA must be \> 14 in patients without psoriasis.
- 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;
- 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.
- 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;
- 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
- 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;
- 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;
- Use of moderate to high dose glucocorticoids (\>10 mg);
- 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.
- Currently pregnant or actively trying to conceive.
Where it is running
14 locations listed across 10 US states.
- Family Arthritis Center - Loxahatchee Groves, Florida, United States
- Healing Rheumatology - Plant City, Florida, United States
- Southwest Florida Rheumatology - Riverview, Florida, United States
- Parris and Associates - Lilburn, Georgia, United States
- University of Massachusetts Chan Medical School - Worcester, Massachusetts, United States
- University of Nebraska Medical Center - Omaha, Nebraska, United States
- New York University - New York, New York, United States
- Cincy Arthritis - Blue Ash, Ohio, United States
- Southern Ohio Rheumatology - Wheelersburg, Ohio, United States
- Hospital at the University of Pennsylvania - Philadelphia, Pennsylvania, United States
- Cumberland Rheumatology - Crossville, Tennessee, United States
- Heritage Rheumatology and Arthritis Care - Colleyville, Texas, United States
- Texas Arthritis Center - El Paso, Texas, United States
- University of Utah - Salt Lake City, Utah, United States