2023-504715-33-00招募中3 期
A Phase 3B, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants with Active Psoriatic Arthritis who had an Inadequate Response and/or Intolerance to One Prior Anti-Tumor Necrosis Factor α Agent
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 229
- 试验地点
- 34
- 主要终点
- Proportion of participants who achieve an ACR 20 response at Week 24
研究概览
简要总结
To evaluate the efficacy of guselkumab treatment in participants with active PsA and IR and/or intolerance to a prior anti-TNF by assessing the reduction in signs and symptoms of PsA
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Be at least 18 years of age
- •Have a diagnosis of PsA for at least 6 months prior to the first administration of study intervention and meet ClASsification criteria for Psoriatic ARthritis criteria at screening.
- •Have active PsA as defined by: a. At least 3 swollen joints and at least 3 tender joints at screening and at baseline AND b. CRP ≥0.3 mg/dL at screening from the central laboratory. NOTE: A 1-time repeat assessment of CRP level is allowed during the 6-week screening phase and the investigator may consider the participant eligible if the test result is within acceptable range on repeat testing in the central laboratory.
- •Have at least 1 of the following PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis.
- •Have an inadequate response and/or intolerance to anti-TNFα therapy, defined as presence of active PsA despite previous treatment with one prior anti-TNFα agent. Participants may meet either one or both of the following criteria: a. Lack of benefit of no more than one prior anti-TNFα therapy, as documented in the patient history by the treating physician, after at least 12 weeks of etanercept, adalimumab, golimumab, or certolizumab pegol therapy or at least a 14-week dosage regimen of infliximab. Documented lack of benefit may include inadequate improvement in joint counts, physical function, or disease activity AND/OR b. Intolerance to no more than one prior anti-TNFα therapy, as documented in the patient history by the treating physician, to etanercept, adalimumab, golimumab, certolizumab pegol, or infliximab.
排除标准
- •Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy in the treatment of PsA, including but not limited to rheumatoid arthritis, ankylosing spondylitis/nonradiographic axial spondyloarthritis, systemic lupus erythematosus, or Lyme disease.
- •Has received more than 1 prior anti-TNFα agent.
- •Has received an anti-TNFα agent within the following timeframes: a. Infliximab or golimumab, within 8 weeks prior to the first administration of study intervention. b. Golimumab SC, adalimumab or certolizumab pegol, within 6 weeks prior to the first administration of study intervention. c. Etanercept within 4 weeks prior to the first administration of study intervention.
- •Has previously received any biologic treatment other than an anti-TNFα agent including, but not limited to, guselkumab, ustekinumab, secukinumab, tildrakizumab, ixekizumab,brodalumab, risankizumab or other investigative biologic treatment.
结局指标
主要结局
Proportion of participants who achieve an ACR 20 response at Week 24
Proportion of participants who achieve an ACR 20 response at Week 24
次要结局
未报告次要终点
研究者
CTIS Point of Contact
Scientific
Janssen - Cilag International
研究点 (34)
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