EUCTR2013-000525-31-GB进行中（未招募）不适用
A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis
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
- Amgen Inc
- 入组人数
- 500
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.Subjects must sign an IRB/IEC-approved ICF before any study specific procedures
- •2.Men or women = 18 and = 80 years old
- •3.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
- •4.Duration of RA of at least 3 months
- •5.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:
- •ESR = 28 mm/hr
- •serum CRP > 1.0 mg/dL
- •6.Positive rheumatoid factor or anti-cyclic citrullinated peptide (CCP) at screening
- •7.Subjects must be taking MTX for = 12 consecutive weeks and on a stable dose of 7.5 to 25 mg/week for > 8 weeks prior to receiving the study drug and be willing to remain on stable dose throughout the study
- •8.For subjects on nonsteroidal anti-inflammatory drugs (NSAIDs) or low potency analgesics such as tramadol, soma compounds, fioricet, fiorinal, dose should be stable for = 2 weeks prior to screening
- •9.For subjects on oral corticosteroids, (= 10 mg prednisone or equivalent), stable doses for = 4 weeks prior to screening
- •10.Subject has no known history of active tuberculosis
- •11.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) OR
- •negative Quantiferon test
- •12.Subjects with a positive PPD and a history of Bacillus Calmette-Guérin vaccination are allowed with a negative Quantiferon test
- •13.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 adequate prophylaxis initiation prior to receiving study drug in accordance with local recommendations
- •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 IP
- •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 450
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Rheumatoid Arthritis related
- •1.Class IV RA according to ACR revised response criteria (Section 17.2)
- •2.Felty’s syndrome (RA, splenomegaly, and granulocytopenia)
- •3.History of prosthetic or native joint infection
- •Other medical conditions
- •4.Planned surgical intervention during the duration of the study
- •5.Active infection or history of infections as follows:
- •any active infection for which systemic anti-infectives were used within 28 days prior to first dose of IP
- •a serious infection, defined as requiring hospitalization or intravenous (IV) anti infectives within 8 weeks prior to the first dose of investigational product
- •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
- •6.Known history of human immunodeficiency virus
- •7.Hepatitis B surface antigen (HbsAg) or Hepatitis C virus (HCV) antibody positivity at screening
- •8.Uncontrolled, clinically significant systemic disease such as diabetes mellitus, cardiovascular disease including moderate to severe heart failure (New York Heart Association [NYHA] class III/IV), renal disease, liver disease or hypertension
- •9.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
- •10.History of neurologic symptoms suggestive of central nervous system demyelinating disease
- •11.Major chronic inflammatory disease or connective tissue disease other than RA, with the exception of secondary Sjögren’s syndrome
- •12.Concurrent medical condition that, in the opinion of the Investigator, could cause this study to be detrimental to the subject
- •Laboratory abnormalities
- •13.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)
- •Any other laboratory abnormality, which, in the opinion of the Investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results
研究者
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