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| Name | Class |
|---|---|
| Janssen Scientific Affairs, LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guselkumab 100mg q4w | Experimental | Guselkumab (GUS) 100mg every 4 weeks |
|
| Guselkumab 100mg q8w | Experimental | Guselkumab (GUS) 100mg every 8 weeks |
|
| Golimumab 50mg q4w | Active Comparator | Golimumab (GOL) 50mg every 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guselkumab | Drug | Guselkumab (GUS) subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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;
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 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.
Currently pregnant or actively trying to conceive.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Gillespie | Contact | (215) 614-1840 | sarah.hopkins@pennmedicine.upenn.edu | |
| Study Coordinator | Contact | SpAProgram@pennmedicine.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Alexis Ogdie-Beatty, MD, MSCE | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Family Arthritis Center | Recruiting | Loxahatchee Groves | Florida | 33470 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40102973 | Derived | 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. |
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| Golimumab | Drug | Golimumab (GOL) subcutaneous injection |
|
|
| 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. | 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. | 6 and 12 months |
| PSAID-12 < 4 | 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. | 6 and 12 months |
| Change in DLQI | Dermatology Life Quality Index (DLQI) is a measure of skin disease activity. Calculated score of 0-30 where higher figures indicate worse status.Negative changes from baseline indicate improvement in disease activity. | 6 and 12 months |
| IGA Among Patients with BSA > 3% at Baseline | Investigator global assessment (IGA) of psoriasis among patients with BSA (Body Surface Area) >3% at baseline. A scale of 0-4 where higher figures indicate worse status. (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe). | 6 and 12 months |
| IGA Among Patients with IGA ≥ 2 at Baseline | Investigator global assessment (IGA) of psoriasis among patients with IGA of 2 or more (≥ 2) at baseline. A scale of 0-4 where higher figures indicate worse status. (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe). | 6 and 12 months |
| Change in Promis Fatigue | Promis Fatigue is a measure of fatigue with a score from 8-40 where higher figures indicate worse status. A negative change indicates less overall fatigue. | 6 and 12 Months |
| Resolution of Dactylitis | Dactylitis is assessed using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. These results are summed to produce a final score ranging from 0 to 20. A higher score indicates more severe dactylitis. Resolution of dactylitis is defined as a dactylitis score of 0 with a baseline dactylitis score >0. | 6 and 12 Months |
| Resolution of Enthesitis | Enthesitis is assessed using the Leeds Enthesitis Index (LEI). This measure includes the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The total LEI score of 0-6 is based on evaluating each of these six sites as 0 or 1 based on the absence or presence of pain/tenderness. Resolution of enthesitis is defined as a enthesitis score of 0 with a baseline enthesitis score >0. | 6 and 12 Months |
| Change in BASDAI | Change in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) among patients with axial disease. The BASDAI sum score ranges from 0 to 10 and higher values indicate more active disease. Negative changes from baseline indicate improvement in disease activity. | 6 and 12 Months |
| Healing Rheumatology | Recruiting | Plant City | Florida | 33563 | United States |
|
| Southwest Florida Rheumatology | Recruiting | Riverview | Florida | 33569 | United States |
|
| Parris and Associates | Recruiting | Lilburn | Georgia | 30047 | United States |
|
| University of Massachusetts Chan Medical School | Recruiting | Worcester | Massachusetts | 01655 | United States |
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| University of Nebraska Medical Center | Recruiting | Omaha | Nebraska | 68198 | United States |
|
| New York University | Recruiting | New York | New York | 10016 | United States |
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| Cincy Arthritis | Recruiting | Blue Ash | Ohio | 45242 | United States |
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| Southern Ohio Rheumatology | Recruiting | Wheelersburg | Ohio | 45694 | United States |
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| Hospital at the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Cumberland Rheumatology | Recruiting | Crossville | Tennessee | 38555 | United States |
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| Heritage Rheumatology and Arthritis Care | Recruiting | Colleyville | Texas | 76034 | United States |
|
| Texas Arthritis Center | Recruiting | El Paso | Texas | 79902 | United States |
|
| University of Utah | Recruiting | Salt Lake City | Utah | 84132 | United States |
|
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000588857 | guselkumab |
| C529000 | golimumab |
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