IRCT2015030321315N1已完成3 期
A Phase III, randomized, two-armed, double-blind (patient and assessor blinded), parallel active controlled non-Inferiority clinical trial to determine the non-inferior therapeutic efficacy and safety of two disease-modifying anti rheumatic drugs (CinnoRA ) versus Humira® for treatment of Active rheumatoid arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 136
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 75 years（—）
- 性别
- All
入选标准
- •Are male or female aged 18-75 years at the time of signing the informed consent form; Have been diagnosed as having active Rheumatoid Arthritis according to the EULAR criteria; moderately to severely active RA for at least 6 months; Patients who have inadequate response to the treatment with usual non-biological regimen for at least 12 weeks according to their investigator judgment; Ability to comprehend and willingness to sign the Informed Consent Form for this study
- •Exclusion criteria: liver Enzymes ALT or AST more than 2 Upper Limit Normal; Hemoglobin less than 8.5 mg/dL; Platelet count less than 125000 cell/mm3; WBC less than 3500 cell/mm3; Serum creatinine more than 2 mg/dL; Concomitant use of corticosteroids, prednisolone more than 10 mg/day or concomitant use of NSAIDS more than recommended dose of company; Treatment with intravenous, intramuscular, intra-articular and parenteral corticosteroids within 4 weeks prior to Day 1 more than 7.5 mg/daily ; Pregnancy, breasfeeding, or planning for being pregnant; History of CHF (Class III/IV) according to NYHA classification; demyelinating disorders, CHF; acute myocardial infarction or unstable angina within the previous 12 months prior to Screening, any malignancy within the previous 5 years prior to Screening, Any other disease or disorder which put the subject at risk if they are enrolled,, in the opinion of the Investigator, History of HIV, a positive serological test for HBV or HCV; Have a known hypersensitivity to human immunoglobulin proteins or other components of Humira or Adalimumab; Have been treated previously with any biological agents including any tumor necrosis factor inhibitor; Physical incapacitation (ACR functional Class IV or wheelchair-/bed-bound); Have had a serious infection or have been treated with intravenous antibiotics for an infection within 8 weeks or oral antibiotics within 2 weeks prior to screening; history of chronic or recurrent infection
排除标准
- 未提供
研究者
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