Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients: a Pragmatic Trial (EVOLUTION)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 63
- 试验地点
- 14
- 主要终点
- Achievement of cDAPSA low disease activity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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 ≥
- •In patients without psoriasis, cDAPSA must be > 14 to meet eligibility requirements.
- •Currently pregnant or actively trying to conceive.
研究组 & 干预措施
Guselkumab 100mg q4w
Guselkumab (GUS) 100mg every 4 weeks
干预措施: Guselkumab (Drug)
Guselkumab 100mg q8w
Guselkumab (GUS) 100mg every 8 weeks
干预措施: Guselkumab (Drug)
Golimumab 50mg q4w
Golimumab (GOL) 50mg every 4 weeks
干预措施: Golimumab (Drug)
结局指标
主要结局
Achievement of cDAPSA low disease activity
时间窗: 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
时间窗: 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).
次要结局
- Minimal Disease Activity (MDA) using HAQ-DI(6 and 12 months)
- IGA Among Patients with BSA > 3% at Baseline(6 and 12 months)
- Resolution of Dactylitis(6 and 12 Months)
- Change in PSAID-12(6 and 12 months)
- PSAID-12 < 4(6 and 12 months)
- Change in DLQI(6 and 12 months)
- Resolution of Enthesitis(6 and 12 Months)
- Change in BASDAI(6 and 12 Months)
- Minimal Disease Activity (MDA) using PSAID-12(6 and 12 months)
- IGA Among Patients with IGA ≥ 2 at Baseline(6 and 12 months)
- Change in Promis Fatigue(6 and 12 Months)