Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients

Phase 3RecruitingNCT05669833

University of Pennsylvania63 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Psoriatic Arthritis

Interventions

GuselkumabDRUG

Guselkumab (GUS) subcutaneous injection

GolimumabDRUG

Golimumab (GOL) subcutaneous injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (14)

Family Arthritis Center

Loxahatchee Groves, Florida, United States

RECRUITING

Healing Rheumatology

Plant City, Florida, United States

Outcomes

Primary Outcomes

Achievement of cDAPSA low disease activity

Clinical Disease Activity in Psoriatic Arthritis (cDAPSA): a combination score of tender joint count, swollen joint count, patient assessment of pain, and patient global assessment of disease activity. Scale from 0-154 where higher figures indicate worse status. Remission is considered ≤4 and low disease activity \>4 to ≤13.

Time frame: 12 Months

Investigator Global Assessment of Psoriasis of Clear or Almost Clear

Investigator global assessment (IGA) of psoriasis. A scale of 0-4 where higher figures indicate worse status. (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe).

Time frame: 12 Months

Secondary Outcomes

Minimal Disease Activity (MDA) using PSAID-12

Minimal Disease Activity (MDA) defines a satisfactory state of disease activity that includes 5 domains of PsA. 5/7 of the following criteria must be satisfied for MDA: patient global ≤ 2 (0-10), patient pain ≤ 2 (0-10), PSAID-12 \<4 (0-10), TJC (Tender Joint Count) ≤ 1, SJC (Swollen Joint Count) ≤ 1, BSA (Body Surface Area) ≤ 3, and Leeds Enthesitis Index ≤ 1.

Time frame: 6 and 12 months

Minimal Disease Activity (MDA) using HAQ-DI

(MDA) Minimal Disease Activity defines a satisfactory state of disease activity that includes 5 domains of PsA. Participant would need to achieve 5/7 of the following criteria: patient global ≤ 2 (0-10), patient pain ≤ 2 (0-10), HAQ-DI (Health Assessment Questionnaire Disability Index) \< 0.5 (0-3), TJC (Tender Joint Count) ≤ 1, SJC (Swollen Joint Count) ≤ 1, BSA (Body Surface Area) ≤ 3, and Leeds Enthesitis Index ≤ 1.

Time frame: 6 and 12 months

Change in PSAID-12

Psoriatic Arthritis Impact of Disease Questionnaire 12-item questionnaire (PSAID-12) Survey. The range of the final PsAID-12 value is 0-10 where higher figures indicate worse status. Negative changes from baseline indicate improvement in disease activity.

Central Contacts

Sarah Gillespie

CONTACT

(215) 614-1840 sarah.hopkins@pennmedicine.upenn.edu

Study Coordinator

CONTACT

SpAProgram@pennmedicine.upenn.edu

Data from ClinicalTrials.gov

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