EUCTR2009-012265-60-PL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
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
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 f
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
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