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Compares treatment options for Psoriatic Arthritis
Official title Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
ClinicalTrials.gov ID: NCT05669833
What this study is testing
What is Guselkumab?
Guselkumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for psoriatic arthritis.
Also referred to as Tremfya.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- If using an oral small molecule/csDMARD (i.e., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine, or apremilast), must be on a stable dose...
You likely can't join if
- 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...
- An adverse event that precludes use of another TNFi (development of drug-induced SLE, allergic reaction, serious infection, heart failure symptoms...
- 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...
- Currently pregnant or actively trying to conceive.
See the full eligibility 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...
- 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).
- 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...
- 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...
- Currently pregnant or actively trying to conceive.
The study team makes the final eligibility decision.
Where it's taking place
- Loxahatchee Groves, Florida, United States
- Plant City, Florida, United States
- Riverview, Florida, United States
- Lilburn, Georgia, United States
- Worcester, Massachusetts, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Blue Ash, Ohio, United States
- Wheelersburg, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Crossville, Tennessee, United States
- Colleyville, Texas, United States
- El Paso, Texas, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Loxahatchee Groves, Florida, United States; Plant City, Florida, United States; Riverview, Florida, United States; Lilburn, Georgia, United States; Worcester, Massachusetts, United States; Omaha, Nebraska, United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.