2023-503435-17-00招募中3 期
A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD)
Amgen Inc.37 个研究点 分布在 12 个国家目标入组 51 人开始时间: 2022年2月22日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 51
- 试验地点
- 37
- 主要终点
- Number of participants achieving ACR Pedi 30 from baseline (week 0) to week 16
研究概览
简要总结
Estimate the efficacy of apremilast compared with placebo in the treatment of Juvenile Psoriatic Arthritis in pediatric subjects 5 to less than 18 years of age
研究设计
- 分配方式
- Randomized
- 主要目的
- Total Study Duration For An Individual Subject Is Approximately 62 Weeks
- 盲法
- Double (Carer, Monitor, Subject, Investigator, Analyst)
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Male or Female subjects 5 to less than 18 years of age at the time of randomization.
- •Confirmed diagnosis of JPsA according to the International League of Associations for Rheumatology (ILAR) Edmonton Revision (Petty, 2001) classification criteria of at least 6 months duration: •Arthritis and psoriasis, OR •Arthritis with at least 2 of the following: dactylitis; nail pitting or onycholysis; psoriasis in a first-degree relative
- •Active disease: at least 3 active joints
- •Inadequate response (at least 2 months) or intolerance to at least 1 DMARD, (which may include MTX or biologic agents).
- •Other protocol-defined inclusion criteria apply.
排除标准
- •Rheumatic autoimmune disease other than PsA, including, but not limited to: systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or fibromyalgia.
- •Prior history of or current inflammatory joint disease other than PsA (eg, gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease).
- •Exclusions per ILAR Edmonton Revision (Edmonton, 2001) criteria for JPsA include: rthritis in an HLA-B27-positive male with arthritis onset after 6 years of age; Ankylosing spondylitis, sacroiliitis with inflammatory bowel disease, Reiter's syndrome, acute anterior uveitis, or a history of one of these disorders in a first-degree relative; History of IgM rheumatoid factor on at least 2 occasions at least 3 months apart; Presence of systemic JIA
- •Other protocol-defined exclusion criteria apply.
研究组 & 干预措施
Apremilast placebo product is supplied to the clinic as 10, 20 and 30 mg tablets and 5 mg/mL oral solution. The placebo product is the same as the drug product formulation except there is no active apremilast.
Placebo
干预措施: Apremilast placebo product is supplied to the clinic as 10, 20 and 30 mg tablets and 5 mg/mL oral solution. The placebo product is the same as the drug product formulation except there is no active apremilast. (Drug)
Apremilast, Apremilast, Apremilast, Apremilast
Test
干预措施: Apremilast (Drug)
结局指标
主要结局
Number of participants achieving ACR Pedi 30 from baseline (week 0) to week 16
Number of participants achieving ACR Pedi 30 from baseline (week 0) to week 16
次要结局
- Change in Juvenile Arthritis Disease Activity Score (JADAS) (a)
- Refer to protocol for fully list of secondary endpoints.
- PASI-75 response at week 16 for subjects with a baseline psoriasis BSA equal or more than 3% (a)
- Number of participants who experience PsA flares (a)
- Change in subject's assessment of pain (a)
- Number of participants achieving ACR Pedi 20/50/70/90 (a)
- Change in Childhood Heath Assessment Questionnaire (CHAQ) (a)
研究者
Medical Information
Scientific
Amgen Inc.
研究点 (37)
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