IRCT20150303021315N9招募中3 期
A phase 3, randomized, multicenter, double-blind, two-armed, parallel, active-controlled, equivalency clinical trial to compare efficacy and safety of Temziva (Tocilizumab produced by AryoGen Pharmed) versus Actemra® (Tocilizumab produced by Genentech-Roche co.) in patients with active moderate to severe rheumatoid arthritis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 272
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 65 years（—）
- 性别
- All
入选标准
- •Male or female aged 18 –65 years at the time of signing the informed consent form
- •Participants who have been diagnosed as having rheumatoid arthritis for at least 6 months, using the 2010 American College of Rheumatology/European League Against Rheumatism (2010 ACR/EULAR) classi?cation criteria for RA.
- •Patients who have an inadequate response of at least 12 weeks to = 1 conventional disease-modifying antirheumatic drugs (DMARDs) in which 1 of them is definitely methotrexate, according to their investigator judgment.
- •Moderate to severe rheumatoid arthritis with =4 tender joints (of 68 joints); =4 swollen joints (of 66 joints); and an erythrocyte sedimentation rate (ESR) =30 mm/hour or a C-reactive protein level (CRP) =1.0 mg/dl at screening
- •Patients discontinued all biological DMARD, including etanercept for 2 weeks or longer and in?iximab, certolizumab, golimumab or adalimumab for 8 weeks or longer because of side effects, lack of compliance or lack of response.
- •Ability to comprehend and willingness to sign the Informed Consent Form for this study
排除标准
- •Active tuberculosis or Patients testing positive for latent tuberculosis (PPD > abnormal CXR)
- •Have a history of serious allergies or a known hypersensitivity to Tocilizumab or any components of the formulations.
- •Have an active hepatitis B or C or positive hepatitis B surface antigen or hepatitis C antibody.
- •Have a known history of infection with human immunodeficiency virus (HIV).
- •Patients who are weighing = 100 kg
- •Patients who had thrombocytopenia (platelet count < 100,000/µl) or Leucopenia (ANC<2,000/µl or white blood cell count < 3,500/µl).
- •Patients with aspartate transaminase (AST), alanine transaminase (ALT) 1.5-fold the upper limit of maximum-normal.
- •Patients with Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in Rheumatoid Arthritis. (Class IV: Advanced persistent limitation inability to perform usual self-care, vocational, and avocational activities).
- •Patients who have been received previous treatment with Tocilizumab
- •Patients who had received plasmapheresis or major surgery (including joint surgery, major cardiovascular surgery except for revascularization) within 8 weeks before entering study or planned major surgery within 6 months after entering the study.
- •Patients who had previously received Rituximab within one year before starting the study.
- •Patients who had received oral glucocorticoids at a dosage of > 10 mg/day of prednisolone or equivalent; or had a dose increase, new administration, or intravenous, intraarticular or intramuscular injections of glucocorticoids within 4 weeks of Tocilizumab treatment.
- •Patients who had dose changes or added-in DMARDs or immunosuppressants within 4 weeks of Tocilizumab treatment.
- •Immunization with a live/attenuated vaccine less than 4 weeks before baseline or planning to receive a live vaccine during the study.
- •Women who are pregnant, breastfeeding or planning to become pregnant during the study.
- •Patients who have stopped previous MTX treatment due to hepatotoxicity.
- •Patients with an active infection or who 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.
- •Having history of any malignancy within the previous 5 years prior to Screening.
- •Having rheumatic disease or inflammatory joint disease other than rheumatoid arthritis
- •Having history of demyelinating disorders including multiple sclerosis.
- •Patients with a certain history of gastrointestinal disorders such as diverticulitis, active peptic ulcer or active duodenal ulcer which have been approved by a gastroenterologist.
- •Patients who had GFR< 60 ml/min/1.73 m2
- •Patients with a history of treatment with cyclosporine or tacrolimus within 1 month of receiving tocilizumab.
- •Having any other disease or disorder which, in the opinion of the Investigator, will put the subject at risk if they are enrolled.
- •Patients who had previously received JAK inhibitors.
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