A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Subjects With Active Nonradiographic Axial Spondyloarthritis

Janssen-Cilag International N.V.0 个研究点目标入组 390 人开始时间: 2015年5月4日最近更新: 2017年7月3日

适应症

试验速览

暂无简介。

•Participants must be classified as having nonradiographic axial spondyloarthritis (nr-AxSpA) based on 2009 Assessment of SpondyloArthritis International Society (ASAS) criteria
•- Must have an age at nr-AxSpA onset of <= 45 years
•- Must have at screening or active inflammation on magnetic resonance imaging (MRI) as evidenced by the central readers and no radiographic sacroiliitis that fulfills the 1984 modified New York Criteria
•- Must have symptoms of active disease at screening and at baseline, as evidenced by both a BASDAI score of >= 4 and a visual analogue scale (VAS) score for total back pain of more than or equal to (>=) 4, each on a scale of 0 to 10
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 390
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Have radiographic sacroiliitis fulfilling the 1984 modified New York Criteria
•- Have other inflammatory diseases that might confound the evaluations of benefit from the ustekinumab therapy
•- Have received any systemic immunosuppressives or disease-modifying anti-rheumatic drug (DMARDs) other than methotrexate (MTX), sulfasalazine (SSZ), or hydroxychloroquine (HCQ) within 4 weeks prior to first administration of study agent
•- Have received epidural, intra-articular, intramuscular (IM), or intravenous (IV) corticosteroids, including adrenocorticotropic hormone during the 4 weeks prior to first administration of study agent
•- Have received prior biologic therapy other than anti-TNFa
•- Have received more than 1 prior anti-TNFa agent

发起方