Clinical trial NCT05669833: Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
Official title: Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients: a Pragmatic Trial (EVOLUTION)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Psoriatic Arthritis
Keywords: Psoriatic Arthritis
PsA
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Janssen Scientific Affairs, LLC
First posted: 2023-01-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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:

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.

Primary outcomes:
measure: Achievement of cDAPSA low disease activity
timeFrame: 12 Months
measure: Investigator Global Assessment of Psoriasis of Clear or Almost Clear
timeFrame: 12 Months
Secondary outcomes:
measure: Minimal Disease Activity (MDA) using PSAID-12
timeFrame: 6 and 12 months
measure: Minimal Disease Activity (MDA) using HAQ-DI
timeFrame: 6 and 12 months
measure: Change in PSAID-12
timeFrame: 6 and 12 months
measure: PSAID-12 < 4
timeFrame: 6 and 12 months
measure: Change in DLQI
timeFrame: 6 and 12 months
measure: IGA Among Patients with BSA > 3% at Baseline
timeFrame: 6 and 12 months
measure: IGA Among Patients with IGA ≥ 2 at Baseline
timeFrame: 6 and 12 months
measure: Change in Promis Fatigue
timeFrame: 6 and 12 Months
measure: Resolution of Dactylitis
timeFrame: 6 and 12 Months
measure: Resolution of Enthesitis
timeFrame: 6 and 12 Months
measure: Change in BASDAI
timeFrame: 6 and 12 Months
Other outcomes:
Locations:
city: Loxahatchee Groves
country: United States
facility: Family Arthritis Center
state: Florida
city: Plant City
country: United States
facility: Healing Rheumatology
state: Florida
city: Riverview
country: United States
facility: Southwest Florida Rheumatology
state: Florida
city: Lilburn
country: United States
facility: Parris and Associates
state: Georgia
city: Worcester
country: United States
facility: University of Massachusetts Chan Medical School
state: Massachusetts
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: New York
country: United States
facility: New York University
state: New York
city: Blue Ash
country: United States
facility: Cincy Arthritis
state: Ohio
city: Wheelersburg
country: United States
facility: Southern Ohio Rheumatology
state: Ohio
city: Philadelphia
country: United States
facility: Hospital at the University of Pennsylvania
state: Pennsylvania
city: Crossville
country: United States
facility: Cumberland Rheumatology
state: Tennessee
city: Colleyville
country: United States
facility: Heritage Rheumatology and Arthritis Care
state: Texas
city: El Paso
country: United States
facility: Texas Arthritis Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Pennsylvania
name: Alexis Ogdie-Beatty, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: