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) - 20190529

Amgen Inc.0 个研究点目标入组 65 人开始时间: 2024年1月19日最近更新: 2024年8月21日

试验速览

暂无简介。

•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 (including distal interphalangeal 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.

•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.

发起方

Amgen Inc.