A Phase 3 Multicenter, Randomized, Double-blind, Placebo controlled trial of Ustekinumab, a Fully Human anti-IL 12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Psoriatic Arthritis. - PSUMMIT I

Centocor B.V.0 个研究点目标入组 600 人2009年11月17日

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注册库

who.int

开始日期

2009年11月17日

结束日期

待定

最后更新

12年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

Centocor B.V.

•Potential subjects must satisfy all of the following criteria to be enrolled in the study:
•Men or women between 18 and 99 years of age, inclusive.
•Have had PsA at least 6 months prior to the first administration of study agent.
•Have a diagnosis of active PsA as defined by:
•– 5 or more swollen joints and 5 or more tender joints at screening and at baseline
•\-AND\- C\-reactive protein (CRP) \= 0\.3 mg/dL at screening.
•Have at least 1 of the PsA subsets: DIP joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis.
•Have active plaque psoriasis or a documented history of plaque psoriasis.
•Have active PsA despite current or previous DMARD and/or NSAID therapy.
•DMARD therapy is defined as taking a DMARD for at least 3 months, or evidence of

•Have other inflammatory diseases that might confound the evaluations of benefit of
•ustekinumab therapy.
•Are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in
•the study or within 15 weeks after receiving the last administration of study agent.
•Have used any therapeutic agent targeted at reducing IL\-12 or IL\-23\.
•Have used any investigational drug within the previous 4 weeks or 5 times the t1/2 of the investigational agent, whichever is longer.
•Have used any biologic agents that are targeted for reducing TNFa, including but not limited to infliximab, etanercept, adalimumab, golimumab, and certolizumab pegol.
•Have received natalizumab, efalizumab, or agents that deplete B or T cells within 12 months of screening, or, if after receiving these agents, evidence is available at screening of persistent depletion of the targeted lymphocyte population.
•Have used alefacept within 3 months prior to the first administration of study agent.
•Have received abatacept.