A Phase 2, Multicenter, Randomized, Double-blind, Placebo controlled Trial of CNTO 1275, a Fully Human Anti IL 12 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Psoriatic Arthritis

Centocor B.V.0 个研究点目标入组 140 人开始时间: 2005年12月16日最近更新: 2012年3月19日

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: 140

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

•subjects must meet all of the following criteria:
•1. Are 18 years of age or older at time of consent; may be male or female.
•2. Have had a diagnosis of PsA at least 6 months prior to the first administration of study agent.
•3. Have a diagnosis of active PsA at the time of screening and baseline, as defined by:3 or more swollen joints and 3 or more tender joints
•-AND at least one of the following-
•Morning stiffness of = 45 minutes
•C-reactive protein (CRP) = 1.5 mg/dL
•4. 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.
•5. Are negative for RF.
•6. Have active plaque psoriasis, with a qualifying target lesion of at least 2 cm in diameter, but not on axilla, inframammary area, or groin.
•7. Women of childbearing potential and all men must be using adequate birth control measures (eg, abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) and must agree to continue to use such measures until 12 months after receiving the last injection of study agent.
•8. Are able to adhere to the study visit schedule and other protocol requirements.
•9. Are capable of giving informed consent and the consent must be obtained prior to any study related procedures.
•10. Must avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during study.
•11. Have active arthritis despite current or previous DMARD and/or NSAID therapy, or prior exposure to anti-TNF agents. 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.
•12. If using MTX, subjects 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 route of administration and doses (not to exceed 25 mg/week) 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.
•13. 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.
•14. If using oral corticosteroids, the subject must be on a stable dose equivalent to = 10 mg of prednisone/day for at least 2 weeks prior to the first administration of study agent. If currently not using oral corticosteroids, the subject must not have received oral corticosteroids for at least 2 weeks prior to the first administration of study agent.
•15. Must agree not to receive a live virus or live bacterial vaccination during the trial or up to 12 months after the last study agent injection.
•16. Must agree not to receive a bacille Calmette-Guerin (BCG) vaccination during the trial or up to 12 months after the last study agent injection.
•17. Have screening laboratory test results within the following parameters:
•a. Hemoglobin = 8.5 g/dL (SI: = 85 g/L)
•b. White blood cells= 3.5 billion/L (SI: = 3.5 billion cells/L)
•c. Neutrophils = 1.5 billion/L (SI: = 1.5 billion cells/L)
•d. Platelets = 100 billion/L (SI: = 100 billion cells/L)
•e. Serum creat

排除标准

•1.Are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in the study or within 12 months after receiving the last administration of study agent.2.Have other inflammatory diseases that might confound the evaluations of benefit of CNTO 1275 therapy, including but not limited to RA, ankylosing spondylitis, systemic lupus erythematosus, or Lyme disease.3.Have ever received any therapeutic agent targeted at reducing IL-12 or IL-23, including but not limited to CNTO 1275 and ABT-874.4.Have used any investigational drug within the previous 4 weeks or 5 times the t1/2 of the investigational agent, whichever is longer or 3 months for any biologic of unknown t1/2.5.Have used any biologic within the previous 4 weeks or 5 times the t1/2 of the biologic, whichever is longer.6.Have ever received natalizumab or other agents that target alpha-4-integrin.7.Have ever received rituximab.8.Have received DMARDs other than MTX within 4 weeks prior to the first administration of the study agent.9.Have received leflunomide within 4 weeks prior to the first administration of study agent (irrespective of undergoing a drug elimination procedure), or have received leflunomide within 3 months prior to the first administration of study agent and have not undergone a drug elimination procedure.10.Have received phototherapy or any systemic medications/treatments that could affect psoriasis or PASI evaluation within 4 weeks of the first administration of study agent. 11.Have used topical medications/treatments that could affect psoriasis or PASI evaluation within 2 weeks of the first administration of study agent. Acceptable low-potency corticosteroids include 2.5% concentration or less of hydrocortisone cream or equivalent.12.Have received any systemic immunosuppressives within 4 weeks of the first administration of the study agent.13.Have received intra-articular, intramuscular (IM), or IV corticosteroids, including adrenocorticotropic hormone administered intramuscularly during the 4 weeks prior to the first administration of the study agent.14.Are currently receiving lithium or have received lithium within 4 weeks of the first administration of the study agent.15.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 12 months after the last administration of study agent.16.Have received, or are expected to receive, a BCG vaccination within 12 months of screening, during the trial, or within 12 months after the last administration of study agent.17.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.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 or have a serious infection, or have been hospitalized or received IV antibiotics for an infection during the 2 months prior to screening.20.Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening.21.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,

研究者

发起方

Centocor B.V.

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