EUCTR2004-003298-10-GB进行中（未招募）1 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Psoriatic Arthritis - NA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Centocor BV
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
入选标准
- •1. Are women or men 18 years of age or older.
- •2. Have PsA that was diagnosed at least 6 months prior to the first administration of study agent.
- •3. Have active PsA at the time of screening and at baseline, as characterized by 3 or more swollen joints and 3 or more tender joints.
- •4. Have at least 1 of the PsA subsets: DIP joint arthritis, polyarticular arthritis with the absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis.
- •5. Have active plaque psoriasis with a qualifying target lesion equal to or greater than 2 cm in diameter, but not on axilla, inframammary area, or groin.
- •6. Are negative for RF according to the reference range of the central laboratory conducting the test.
- •7. Have active arthritis despite current or previous DMARD 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.
- •8. Women of childbearing potential or men capable of fathering children must be using adequate birth control measures during the study and for 6 months after receiving the last administration of study agent. Female subjects of childbearing potential must test negative for pregnancy.
- •9. Are considered eligible according to the following TB screening criteria:
- •a. Have no history of latent or active TB prior to screening.
- •b. Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.
- •c. 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.
- •d. Within 1 month prior to the first administration of study agent, either have negative diagnostic TB test results, or have a newly identified positive diagnostic TB test result during screening 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.
- •e. Have a chest radiograph (both posterior-anterior and lateral views), 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.
- •10. If using MTX, should have started treatment at least 3 months prior to the first administration of study agent and should have no serious toxic side effects attributable to MTX. MTX routes of administration and doses (not to exceed 25 mg/week) should be stable for at least 4 weeks prior to the first administration of the 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.
- •11. If using NSAIDs, must be on a stable dose for at least 2 weeks prior to the first administration of study agent. If currently not using NSAIDS, must not have received NSAIDs for at least 2 weeks prior to the first administration of the study agent.
- •12. If using oral corticoster
排除标准
- •1. Have other inflammatory diseases that might confound the evaluations of benefit from the golimumab therapy, including but not limited to RA, ankylosing spondylitis, systemic lupus erythematosus, or Lyme disease.
- •2. Are pregnant, nursing, or planning a pregnancy or fathering a child within 6 months after receiving the last administration of study agent.
- •3. Have received any systemic immunosuppressives within 4 weeks prior to the first administration of study agent.
- •4. Have received DMARDs other than MTX or anakinra within 4 weeks prior to the first administration of study agent.
- •5. Have received leflunomide within 4 weeks prior to the first administration of study agent, or have received leflunomide within 3 months prior to the first administration of study agent and have not undergone a drug elimination procedure.
- •6. Have received intra-articular, IM, or IV corticosteroids, including adrenocorticotropic hormone during the 4 weeks prior to the first administration of study agent.
- •7. Have used alefacept or efalizumab within 3 months prior to the first administration of study agent.
- •8. Have used any biologic agents that are targeted for reducing TNFalfa, including but not limited to infliximab, etanercept, and adalimumab.
- •9. Have used rituximab or natalizumab.
- •10. Have a known hypersensitivity to human immunoglobulin proteins or other components of golimumab.
- •11. Have used cytotoxic drugs, including chlorambucil, cyclophosphamide, nitrogen mustard, or other alkylating agents.
- •12. Have been treated with any investigational drug within 5 half-lives of that drug prior to the first administration of study agent.
- •13. Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening.
- •14. Have had a Bacille Calmette-Guérin (BCG) vaccination within 12 months of screening.
- •15. Have a chest radiograph within 3 months prior to the first administration of study agent that shows an abnormality suggestive of a malignancy or current active infection, including TB.
- •16. Have had a nontuberculous mycobacterial infection or opportunistic infection within 6 months prior to screening.
- •17. Have received, or are expected to receive, any live virus or bacterial vaccination within 3 months before the first administration of study agent, during the trial, or within 6 months after the last administration of study agent.
- •18. 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.
- •19. Have had a serious infection or have been hospitalized for an infection, or have been treated with IV antibiotics for an infection within 2 months prior to the first administration of study agent.
- •20. Have a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection, sinusitis, recurrent urinary tract infection, an open, draining, or infected skin wound, or an ulcer.
- •21. Are known to be infected with HIV, hepatitis B, or hepatitis C.
- •22. Have a history of known demyelin
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