KCT0000035已完成未知
A phase I, open label, dose ranging study to evaluate the safety and tolerance of CreaVax-RA in active rheumatoid arthritis patients with usual DMARDs
JW CreaGene0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 70(Year)（—）
- 性别
- All
入选标准
- •1. Patient diagnosed that he/she is with rheumatoid arthritis according to ACR rheumatoid arthritis classification standard reformed in 1987.
- •2. Patient is over 19 and under 71 years old.
- •3. Patient of who rheumatoid arthritis functional status is classified as Class I, II. III according to ACR classification standard.
- •4. Patient is with benign Anti CCP found by screening.
- •5. Patient of who ESR (Erythrocyte Sedimentation Rate) = 28 mm/hour or CRP (C-reactive Protein) = 1.0 mg/dL found by screening
- •6.Patient taking non-biological DMARDs such as MTX with the same quantity before screening for more than 8 weeks and this treatment can be applied for the time being.
- •7. Patient taking oral corticosteroid (prednisone of which amount used is 10mg/day or less) and NSAIDs before screening for more than 4 weeks.
- •8. Patient agreed to contracept until 6months after the clinical trial.
- •9. Patient participates in the clinical trial voluntarily signing up.
排除标准
- •1. Patient had major surgery such as joint surgery within 8 weeks before screening
- •2. Patient is currently with rheumatoid arthritis or rheumatoid autoimmune disease
- •3. Patient is with serious rheumatoid arthritis complication.
- •4. Patient is with rheumatoid arthritis Class IV according to ACR classification
- •5. Patient is currently with or had inflammatory joint disease other than arthritis.
- •6. Child patient is with rheumatoid arthritis.
- •7. Patient is in wash out period after taking the medicine before screening.
- •8. Patient took immunosuppressant within 3 months registration.
- •9. Patient took such treatments as V-globulin IV, Plasmapheresis and Prosorba within 24 weeks
- •10. Patient took other clinical trial medicines within 12 weeks
- •11. Patient is with serious cardiovascular system, nervous system, respiratory system, endocrine
- •system and gastrointestinal system related disease cannot be controlled.
- •12. Patient is with serious high blood pressure.
- •13. Patient could be with renal, liver and biliary tract function disorder.
- •14. Patient with serious asthma, psoriasis, Inflammatory bowel disease cannot be controlled.
- •15. Patient is currently with gastric ulcer, ulcerative stomatitis, ulcerative colitis
- •16. Patient is currently with Bacterial, viral, fungal, mycobacterial other infectious diseases 17. Patient is reluctant to have treatment of latent tuberculosis found by screening
- •18. Patient needs to be hospitalized due to infection diseases, had antibiotics administration in
- •the vein 4 weeks before screening or oral administration 2 weeks before screening.
- •19. Patient is currently with or had primary and secondary immunodeficiency syndrome.
- •20. Patient was prescribed as malignant tumor within a decade.
- •21. Pregnant woman, nursing woman or woman is going to be pregnant within 6 months.
- •22. Patient is judged by the P.I as the patient is not suitable for the research.
- •23. Serum creatinine > ULN/ 24. ALT or AST > 1.5 times of ULN.
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