Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients

Recruiting Phase 3 Interventional Study
Psoriatic Arthritis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
63 (estimated)
Sponsor
University of Pennsylvania · Other
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About This Trial

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.

Trial Locations
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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 …
Contacts

Sarah Gillespie

(215) 614-1840

sarah.hopkins@pennmedicine.upenn.edu

CONTACT

Study Coordinator

SpAProgram@pennmedicine.upenn.edu

CONTACT