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临床试验/EUCTR2009-012264-14-FI
EUCTR2009-012264-14-FI进行中（未招募）不适用

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

Janssen-Cilag Internation N.V.0 个研究点目标入组 600 人开始时间: 2009年12月3日最近更新:
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适应症

试验速览

阶段
不适用
状态
进行中（未招募）
发起方
入组人数
600
研究概览入排标准研究者记录与标识符相似试验

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

  • •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 DMARD intolerance. NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of NSAID intolerance.
  • •Women must be:
  • •– surgically sterile, or
  • •– abstinent (at the discretion of the investigator/per local regulations), or
  • •– if sexually active, be practicing a highly effective method of birth control as local regulations permit, before entry, and must agree to continue to use the same method of contraception throughout the study.
  • •Women of childbearing potential must have a negative serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test at screening; and a negative urine pregnancy test at Week 0.
  • •Men capable of fathering children must agree to use a double barrier method of birth control (or must have been surgically sterilized) and to not donate sperm during the study and for 15 weeks after receiving the last dose of study drug.
  • •Are considered eligible according to the following tuberculosis (TB) screening criteria:
  • •– Have no history of latent or active TB prior to screening.
  • •– Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.
  • •– Have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study agent.
  • •– Within 6 weeks prior to the first administration of study agent, have a negative QuantiFERON-TB Gold test result, or have a newly identified positive QuantiFERON-TB Gold test result in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study agent.
  • •– Have a chest radiograph taken within 3 months prior to the first administration of study agent and read by a qualified radiologist, with no evidence of current, active TB or old, inactive TB
  • •If using MTX, subjects should have started treatment at a dose not to exceed 25 mg/week at least 3 months prior to the first administration of study agent and should have no serious toxic side effects attributable to MTX. MTX route of administration and doses should be stable for at least 4 weeks prior to the first administration of study agent. If currently not using MTX, must have not received MTX for at least 4 weeks prior to the first administration of the study agent.
  • •If using NSAIDs or other analgesics for PsA, must be on a stable dose for at least 2
  • •weeks prior to the first administrati

排除标准

  • •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.
  • •Known allergies, hypersensitivity, or intolerance to ustekinumab or its excipients.
  • •Have received DMARDs other than MTX or anakinra within 4 weeks prior to the first administration of the study agent.
  • •Have received leflunomide within 4 weeks prior to the first administration of study agent or have received leflunomide from 4 to 12 weeks prior to the first administration of study agent and have not undergone a drug elimination procedure.
  • •Have received any systemic medications/treatments that could affect psoriasis or PASI evaluation within 4 weeks of the first administration of study agent.
  • •Have used topical medications/treatments that could affect psoriasis or PASI evaluation (including, but not limited to corticosteroids (with the exception of low potency corticosteroids used on the palms, soles, face and/or intertriginous areas), anthralin, calcipotriene, topical vitamin D derivatives, retinoids, tazarotene, methoxsalen, trimethylpsoralens) within 2 weeks of the first administration of study agent.
  • •Have received any systemic immunosuppressives within 4 weeks of the first administration of the study agent.
  • •Have received intra-articular, IM, or IV corticosteroids during the 4 weeks prior to the first administration of the study agent.
  • •Are currently receiving lithium or have received lithium within 4 weeks of the first administration of the study agent.
  • •Have received, or are expected to receive, any live virus or bacterial vaccination within 3 months prior to the first administration of study agent, during the study, or within 12 months after the last administration of study agent.
  • •Have a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection recurrent urinary tract infection, or open, draining, or infected skin wounds or ulcers.
  • •Have a history of an infected joint prosthesis, or have received antibiotics for a suspected infection of a joint prosthesis, if that prosthesis has not been removed or replaced.
  • •Have had or have a serious infection, or have been hospitalized or received IV antibiotics for an infection during the 2 months prior to screening.
  • •Have a history of latent TB or a history of or clinically active granulomatous infection, including TB, histoplasmosis or coccidioidomycosis, prior to screening.
  • •Have had a Bacille Calmette-Guérin (BCG) vaccination within 12 months of screening.
  • •Have a chest radiograph with

研究者

发起方
Janssen-Cilag Internation N.V.

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