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临床试验/EUCTR2009-012265-60-HU
EUCTR2009-012265-60-HU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 Including Those Previously Treated with Biologic Anti-TNFa Agent(s) - PSUMMIT II

Centocor B.V.0 个研究点目标入组 300 人开始时间: 2010年12月21日最近更新:
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适应症
相关药物

试验速览

阶段
不适用
状态
进行中（未招募）
发起方
入组人数
300
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

  • •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
  • •– C-reactive protein (CRP) = 0.3 mg/dL at screening.
  • •Have at least 1 of the PsA subsets:
  • •Have active plaque psoriasis or a documented history of plaque psoriasis.
  • •Have active PsA despite current or previous DMARD and/or NSAID therapy.
  • •Subjects previously treated with a biologic anti- TNFa agent, must have:
  • •– received at least an 8-week dosage regimen of
  • •etanercept, adalimumab, golimumab, or certolizumab pegol; or
  • •– received at least a 14-week dosage regimen of
  • •infliximab; or
  • •– received less than an 8-week dosage regimen of etanercept, adalimumab,
  • •golimumab, or certolizumab pegol or less than a 14-week dosage regimen of
  • •infliximab as described above and have documented intolerance of anti-TNFa
  • •Women must be:
  • •– surgically sterile
  • •– abstinent, 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 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 TB screening criteria:
  • •– Have no history of latent or active TB prior to screening. An exception is made for subjects with prior use of anti-TNFa agent(s) with a history of latent TB and documentation of having completed appropriate treatment for latent TB within 3 years prior to the first administration of study agent. It is the responsibility of the investigator to verify the adequacy of previous antituberculous treatment and provide appropriate documentation.
  • •– 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
  • •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.
  • •If using NSAIDs or other analgesics for PsA, must be on a stable dose for at least

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 received infliximab, golimumab, or certolizumab pegol within 12 weeks prior
  • •to the first administration of the study agent.
  • •Have received adalimumab or etanercept within 8 weeks prior to the first
  • •administration of the study agent.
  • •Have received alpha-4 integrin antagonists 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, administered intramuscularly 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,
  • •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
  • •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 vaccination within 12 months of
  • •Have a chest radiograph within 3 months prior to the first administration of study
  • •agent that shows an a

研究者

发起方
Centocor B.V.

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