New hope for PsA patients: which drug works best after TNFi failure?
NCT ID NCT05669833
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at people with psoriatic arthritis whose symptoms didn't improve enough with a TNF inhibitor. It compares switching to guselkumab (a different type of drug) versus switching to another TNF inhibitor called golimumab. The goal is to see which option better controls joint pain, swelling, and skin symptoms. About 63 adults will take part, and the results will help doctors choose the best next step.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 63 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2023
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
14 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cincy Arthritis
RECRUITINGBlue Ash, Ohio, 45242, United States
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Cumberland Rheumatology
RECRUITINGCrossville, Tennessee, 38555, United States
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Family Arthritis Center
RECRUITINGLoxahatchee Groves, Florida, 33470, United States
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Healing Rheumatology
RECRUITINGPlant City, Florida, 33563, United States
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Heritage Rheumatology and Arthritis Care
RECRUITINGColleyville, Texas, 76034, United States
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Hospital at the University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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New York University
RECRUITINGNew York, New York, 10016, United States
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Parris and Associates
RECRUITINGLilburn, Georgia, 30047, United States
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Southern Ohio Rheumatology
RECRUITINGWheelersburg, Ohio, 45694, United States
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Southwest Florida Rheumatology
RECRUITINGRiverview, Florida, 33569, United States
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Texas Arthritis Center
RECRUITINGEl Paso, Texas, 79902, United States
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University of Massachusetts Chan Medical School
RECRUITINGWorcester, Massachusetts, 01655, United States
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University of Nebraska Medical Center
RECRUITINGOmaha, Nebraska, 68198, United States
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University of Utah
RECRUITINGSalt Lake City, Utah, 84132, United States
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