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 PEAPOD

Amgen0 个研究点目标入组 4 人开始时间: 待定最近更新: 2024年9月9日

适应症

试验速览

暂无简介。

•Male or Female subjects 5 to < 18 years of age at the time of randomization.
•Subject must have a 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:
•o Arthritis and psoriasis, OR
•o 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
•Inadequate response (at least 2 months) or intolerance to >= 1 DMARD, (which
•may include MTX or biologic agents).
•Inclusion criteria are described in more detail in section 5.1 of the protocol.

•Exclusions per ILAR Edmonton Revision (Edmonton, 2001) criteria for JPsA
•o Arthritis in an HLA-B27-positive male with arthritis onset after 6 years of
•o 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
•o History of IgM rheumatoid factor on at least 2 occasions at least 3 months
•o Presence of systemic JIA.
•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
•Exclusion criteria are described in more detail in section 5.2 of the protocol.

发起方