Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
NCT ID: NCT05669833
Last Updated: 2025-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
63 participants
INTERVENTIONAL
2023-07-14
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Guselkumab 100mg q4w
Guselkumab (GUS) 100mg every 4 weeks
Guselkumab
Guselkumab (GUS) subcutaneous injection
Guselkumab 100mg q8w
Guselkumab (GUS) 100mg every 8 weeks
Guselkumab
Guselkumab (GUS) subcutaneous injection
Golimumab 50mg q4w
Golimumab (GOL) 50mg every 4 weeks
Golimumab
Golimumab (GOL) subcutaneous injection
Interventions
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Guselkumab
Guselkumab (GUS) subcutaneous injection
Golimumab
Golimumab (GOL) subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
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.
18 Years
80 Years
ALL
No
Sponsors
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Janssen Scientific Affairs, LLC
INDUSTRY
University of Pennsylvania
OTHER
Responsible Party
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Principal Investigators
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Alexis Ogdie-Beatty, MD, MSCE
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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Family Arthritis Center
Loxahatchee Groves, Florida, United States
Healing Rheumatology
Plant City, Florida, United States
Southwest Florida Rheumatology
Riverview, Florida, United States
Parris and Associates
Lilburn, Georgia, United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
New York University
New York, New York, United States
Cincy Arthritis
Blue Ash, Ohio, United States
Southern Ohio Rheumatology
Wheelersburg, Ohio, United States
Hospital at the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Cumberland Rheumatology
Crossville, Tennessee, United States
Heritage Rheumatology and Arthritis Care
Colleyville, Texas, United States
Texas Arthritis Center
El Paso, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Role: backup
References
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Ogdie A, Reddy SM, Gillespie SH, Husni ME, Scher JU, Salomon-Escoto K, Kay J, Luedders BA, Curtis JR, Shields AJS, Chakravarty SD, Gong C, Walsh JA. Guselkumab versus golimumab in patients with active psoriatic arthritis and inadequate response to an initial tumor necrosis factor inhibitor: study protocol for EVOLUTION, a pragmatic, phase 3b, open-label, randomized, controlled effectiveness trial. Trials. 2025 Mar 19;26(1):96. doi: 10.1186/s13063-025-08777-y.
Other Identifiers
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CNTO1959PSA3006
Identifier Type: -
Identifier Source: org_study_id
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