Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
- Registration Number
- NCT05669833
- Lead Sponsor
- University of Pennsylvania
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- Psoriatic arthritis meeting CASPAR criteria;
- Active psoriatic arthritis defined by at least 1 swollen joint;
- cDAPSA score ≥ 10; See also Exclusion #4 - cDAPSA must be > 14 in patients without psoriasis.
- 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 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.
- 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;
- 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).
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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;
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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;
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Use of moderate to high dose glucocorticoids (>10 mg);
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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.
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Currently pregnant or actively trying to conceive.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Golimumab 50mg q4w Golimumab Golimumab (GOL) 50mg every 4 weeks Guselkumab 100mg q4w Guselkumab Guselkumab (GUS) 100mg every 4 weeks Guselkumab 100mg q8w Guselkumab Guselkumab (GUS) 100mg every 8 weeks
- Primary Outcome Measures
Name Time Method Achievement of cDAPSA low disease activity 12 Months 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.
Investigator Global Assessment of Psoriasis of Clear or Almost Clear 12 Months 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).
- Secondary Outcome Measures
Name Time Method Minimal Disease Activity (MDA) using HAQ-DI 6 and 12 months (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.
IGA Among Patients with BSA > 3% at Baseline 6 and 12 months 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).
Resolution of Dactylitis 6 and 12 Months 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.
Change in PSAID-12 6 and 12 months 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.
PSAID-12 < 4 6 and 12 months 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.
Change in DLQI 6 and 12 months 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.
Resolution of Enthesitis 6 and 12 Months 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.
Change in BASDAI 6 and 12 Months 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.
Minimal Disease Activity (MDA) using PSAID-12 6 and 12 months 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.
IGA Among Patients with IGA ≥ 2 at Baseline 6 and 12 months 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).
Change in Promis Fatigue 6 and 12 Months 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.
Trial Locations
- Locations (14)
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
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
Hospital at the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States