JPRN-jRCT2080223394已完成3 期
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study with an Open Label Extension to Evaluate the Efficacy and Safety of Brodalumab in Subjects with Axial Spondyloarthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 159
研究概览
简要总结
Brodalumab 210 mg was demonstrated to have efficacy in the primary endpoint and the secondary endpoints. Regarding safety, there was no difference from safety profile of brodalumab, which has been confirmed to date for other diseases such as psoriasis. Thus, efficacy and safety of brodalumab 210 mg were demonstrated for axSpA (AS and nr-axSpA) subjects.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Subject with age at onset <45 years and continuous chronic back pain for >= 3 months fulfills the ASAS classification criteria of axial spondyloarthritis (with the exception of the Crohn's disease)
- •-Subject has Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >= 4 at screening and enrollment
- •-Subject has spinal pain score (BASDAI question #2)>= 4 at screening and enrollment
- •-Subject has had adequate therapy with non-steroidal anti-inflammatory drugs (oral NSAIDs) for back pain for at least 3 months with inadequate treatment response before enrollment
排除标准
- •-Complete ankylosis (fusion) of the spine
- •-Subject with active ongoing inflammatory diseases other than axSpA that might confound the evaluation of Brodalumab therapy, including reactive arthritis, spondyloarthritis associated with inflammatory bowel disease, SAPHO syndrome (pustulotic arthro-osteitis), fibromyalgia, ankylosing spinal hyperostosis, osteitis condensans ilii, spondylosis deformans, or osteoarthritis sacroiliac joint disease
- •-Subject has a prior history of >1 anti-tumor necrosis factor therapy
- •-Subject has a history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the Columbia-Suicide Severity Rating Scale (C-SSRS) at enrollment
- •-Subject has a history or evidence of a psychiatric disorder, alcohol and/or substance
- •-Subject has severe depression based on a total score of >= 15 on the Patient Health Questionnaire-8 (PHQ-8) at enrollment (note: subjects with a total score of 10 to 14 on the PHQ-8 should be referred to a mental health care professional)
研究者
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