Psoriasis Clinical Trial
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
Summary
The trial is a double-blinded 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.
Full Description
The primary aim of the trial will be to determine, among psoriatic arthritis (PsA) patients with an inadequate response (IR) to a tumor necrosis factor inhibitor (TNFi), whether switching to a new mechanism of action (MOA), specifically guselkumab (GUS), a selective interleukin 23 inhibitor (IL23i) targeting the p19 subunit, is more effective than switching to another TNFi. The primary hypothesis of this study is that switching to a new MOA may be more effective than switching to a second TNFi. This will be the first trial to test such a switch in PsA patients. Additionally, the proposed study will address the effectiveness of a new therapy, GUS, in a clinical practice setting among patients who are TNF IR.
Eligibility Criteria
Inclusion Criteria:
Psoriatic arthritis meeting CASPAR criteria;
Active psoriatic arthritis defined by the presence of at least 2 swollen joints OR 1 swollen joint and 1 site of active enthesitis OR active dactylitis involving 2 joints
At least one active psoriasis plaque;
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 a single oral small molecule/csDMARD (i.e., methotrexate, leflunomide, hydroxycloroquine, sulfasalazine, or apremilast), must be on a stable dose for 4 weeks and remain on a stable dose during the study; Only use of a single OSM/csDMARD is allowed.
If using NSAIDs, glucocorticoids (<10 mg daily) or topical medications for psoriasis, must be on a stable dose for 4 weeks and remain on a stable dose during the study;
age 18-80
Exclusion Criteria:
Prior exposure to golimumab or another non-TNFi biologic (IL12/23i, JAKi, an IL17i, or an IL23i);
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 meet the primary outcome at screening or baseline
Currently pregnant or actively trying to conceive
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There is 1 Location for this study
Philadelphia Pennsylvania, 19104, United States More Info
Principal Investigator
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