EUCTR2013-005543-90-EE进行中（未招募）1 期
A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis - Not applicable
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 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
- •1.Men or women = 18 and = 80 years old
- •2.Subjects must be diagnosed with RA as determined by meeting 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR)
- •classification criteria for RA
- •3.Duration of RA of at least 6 months
- •4.Active RA defined as = 6 swollen joints and = 6 tender joints (based on 66/68 joint count excluding distal interphalangeal joints) at screening and baseline and at least one of the following at screening:
- •erythrocyte sedimentation rate (ESR) = 28 mm/hr
- •serum C-reactive protein (CRP) > 1.0 mg/dL
- •5.Subjects have had an inadequate response or intolerance to other DMARDs (which must include intolerance or inadequate response to one or more TNF inhibitor therapies).
- •6.Subjects must be taking methotrexate (MTX) for = 12 consecutive weeks and be on a stable dose of MTX 7.5 to 25 mg/week for = 8 weeks prior to receiving the investigational product (IP), and be willing to remain on a stable dose throughout the study
- •8.Subject has a negative test for tuberculosis during screening defined as either:
- •negative purified protein derivative (PPD) < 5 mm of induration at 48 to 72 hours after test is placed)
- •negative Quantiferon test
- •9.Subjects with a positive PPD and a history of Bacillus Calmette-Guérin vaccination are allowed with a negative Quantiferon test
- •10.Subjects with a positive PPD test (without a history of Bacillus Calmette-Guérin vaccination) or subjects with a positive or indeterminate Quantiferon test are allowed if they have all of the following:
- •no symptoms per tuberculosis worksheet provided by the Sponsor, Amgen
- •documented history of treatment with a TB prophylaxis regimen, with at least 4 weeks of prophylaxis therapy completed at the time of screening. If a subject has completed at least 4 weeks of prophylaxis therapy completed at a time of screening. If a subject has completed at least 4 weeks of prophylaxis therapy, and their regimen requires >4 weeks therapy, the subject must be deemed able and willing to complete the entire prophylaxis regimen in accordance with local guidance.
- •no known exposure to a case of active tuberculosis after most recent prophylaxis
- •no evidence of active tuberculosis on chest radiograph within 3 months prior to the first dose of investigational product
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 270
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1.History of prosthetic or native joint infection 2.Active infection or history of infections as follows:
- •any active infection for which systemic anti-infectives were used within 4 weeks prior to first dose of IP
- •a serious infection, defined as requiring hospitalization or IV anti infectives within 8 weeks prior to the first dose of IP
- •recurrent or chronic infections or other active infection that, in the opinion of the Investigator, might cause this study to be detrimental to the subject
- •3.Known history of human immunodeficiency virus
- •4.Hepatitis B surface antigen (HbsAg), Hepatitis B core antibody (anti- HBc) positivity at screening (unless documentation of hepatitis B virus immunization), or Hepatitis C virus (HCV) antibody positivity at screening.
- •5. Uncontrolled, clinically significant systemic disease such as diabetes mellitus, cardiovascular disease including severe heart failure (New York Heart Association [NYHA] class IV), or severe uncontrolled cardiac disease, renal disease, or liver disease
- •6.Malignancy within 5 years EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, OR in situ breast ductal carcinoma
- •7.History of neurologic symptoms suggestive of central nervous system demyelinating disease
- •8.Laboratory abnormalities at screening, including any of the following:
- •hemoglobin < 9 g/dL
- •platelet count < 100,000/mm3
- •white blood cell count < 3,000 cells/mm3
- •aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) = 2.0 x the upper limit of normal
- •creatinine clearance < 50 mL/min (Cockroft-Gault formula)
- •9.Use of commercially available or investigational biologic therapies for RA as follows:
- •anakinra, etanercept within 1 month prior to first dose of IP
- •infliximab, abatacept, tocilizumab, golimumab, certolizumab, adalimumab within 3 months prior to first dose of investigational product
- •other experimental or commercially available biologic therapies for RA within 3 months or 5 half-lives (whichever is longer) prior to first dose of investigational product
- •10.Live vaccines within 28 days prior to the first dose of investigational product
- •11.Previous receipt of rituximab or a biosimilar of rituximab, or ocrelizumab
- •12. For women: pregnant or breast feeding, or planning to become
- •pregnant while enrolled in the study and for 12 months after the last dose of investigational product
- •13.Sexually active subjects and their partners who are of childbearing potential (ie, neither surgically sterile nor postmenopausal) and not agreeing to use adequate contraception (eg, true abstinence, sterilization, birth control pills, Depo-Provera injections, or contraceptive implants) while on study and for 12 months after the last dose of investigational product.
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