EUCTR2019-002788-88-PL进行中（未招募）1 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.0 个研究点目标入组 60 人开始时间: 2022年1月28日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or Female subjects 5 to less than 18 years of age at the time of randomization.
- •2. 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
- •3. Active disease: at least 3 active joints (including distal interphalangeal joints).
- •4. Inadequate response (at least 2 months) or intolerance to = 1 DMARD, (which may include MTX or biologic agents).
- •Other protocol-defined inclusion criteria apply
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 60
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Exclusions per ILAR Edmonton Revision (Edmonton, 2001) criteria for
- •JPsA include:
- •- Arthritis in an HLA-B27-positive male with arthritis onset after 6 years
- •- 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.
- •2. Rheumatic autoimmune disease other than PsA, including, but not
- •limited to: systemic lupus erythematosus, mixed connective tissue
- •disease, scleroderma, polymyositis, or fibromyalgia.
- •3. Prior history of or current inflammatory joint disease other than PsA
- •(eg, gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis,
- •Lyme disease).
- •4. History or evidence of any other clinically significant disorder,
- •condition or disease that could pose a risk to subject safety or interfere
- •with the study evaluation, procedures or completion.
- •5. Female subject who is (or plans to become) pregnant or
- •breastfeeding.
- •6. Female subject of childbearing potential unwilling to use 1 highly
- •effective method of contraception.
- •Other protocol-defined exclusion criteria apply.
研究者
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