KCT0000894招募中未知
A phase IIa, randomized, open-label study evaluating the safety and efficacy of CreaVax-RA combined with traditional disease modifying anti-rheumatic drugs (DMARDs) therapy in patients with moderate to severe active rheumatoid arthritis despite DMARDs therapy
JW CreaGene0 个研究点目标入组 18 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 18
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. Subject is diagnosed with rheumatoid arthritis as determined by 2010 ACR/EULAR rheumatoid arthritis clasification criteria and has had rheumatoid arthritis for at least 6 months.
- •2. Subject is over 19 and under 71 years old.
- •3. Functional class I, II, III as defined by ACR classification of functional status in RA.
- •4. Subjects who are positive in at least one or more of antibody of auto-antigens (RA33, PAD4, c-FLG, Vimentin).
- •*The criteria to determine positivity for the test result is above average value of normal samples ELISA O.D x 1.5.
- •5. Subjects who have an inadequate response to alone or in combination with DMARDs(Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, tacrolimus) for at least 12 weeks.
- •6. Subject who positive in anti-CCP
- •7. Subject has active rheumatoid arthritis defined as = 4 tender joint count (out of 68 joint count) and = 4 swollen joint count (out of 66 joint count) and ESR (Erythrocyte Sedimentation Rate) = 28 mm/hour or CRP (C-reactive Protein) = 1.0 mg/dL
- •8. Subjects receiving a nonsteroidal anti-inflammatory drug (NSAID) and/or prednisone (10 or less mg day) must be on stable doses of these agents for more than 4 weeks.
- •9. Subject who consent to use contraception during the trial or for 6 months following end of study.
- •10. Subject who decide to participate in clinical trials and signed a consent form
排除标准
- •1. Rheumatic autoimmune disease other than RA, including systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis.
- •2. Subject is with serious rheumatoid arthritis complication (eg; vasculitis, pulmonary fibrosis or Felty's syndrome except Sjogren’s syndrome)
- •3. Functional class IV as defined by ACR classification of functional status in RA.
- •4. Subject must not have a disgnosis or history of any other inflammatory arthritis (eg, gout, reactive arthritis, psoriatic arthritis, Seronegative spondyloarthropathy or lyme disease)
- •5. Juvenile rheumatoid arthritis
- •6. Exclusion laboratory
- •Hemoglobin = 8.5 g/dL, WBC count = 3,000/mm^3, platelet = 50,000/uL
- •7. Systemic disease;
- •-Subject with an active malignancy of any type or a history of malignancy within 10 years. (except basal cell carcinoma of the skin that has been excised prior to study start)
- •-Subject with severe cardiovascular, digestive, respiratory, endocrine, hematologic, neurologic disease
- •-Subject who underwent major surgery within 8 weeks, including joint surgery.
- •-Durg abuse
- •-Subject with severe hypertension (SBP = 180 or DBP = 110 mmHg)
- •8. Subject took other clinical trial medicines within 12 weeks
- •9. Subject is in wash out period after taking the medicine before screening.
- •-Etanercept: = 2 weeks
- •-Infliximab, adalimumab: = 8 weeks
- •-Abatacept: = 12 weeks
- •-Rituximab: = 36 weeks
- •-Intra articular or parenteral corticosteroid = 6 weeks (IV or IM)
- •-Alkylating agents(eg; cyclophosphamide, chlorambucil) or total lymphoid irradiation: = 1 year
- •-Attenuated/live vaccine: = 4 weeks
- •10. Subject took immunosuppressant(eg Cyclosporin, azathiopurine) within 3 months registration.
- •11. Subject took such treatments as V-globulin IV, Plasmapheresis and Prosorba within 24 weeks
- •12. Subject could be with renal, liver and biliary tract function disorder.
- •13. Subject is reluctant to have treatment of latent tuberculosis found by screening
- •14. Subject is currently with Bacterial, viral, fungal, mycobacterial other infectious diseases, including Hepatitis B, C and HIV. Subject had antibiotics I.V administration within 4 weeks or oral administration 2 weeks before screening.
- •15. Female patients who are breast feeding, pregnant, or plan to become pregnant within 6 months.
- •16. Subject is currently with or had primary and secondary immunodeficiency syndrome.
- •17. Subject must not have any other condition which, in the investigator's judgement, would make them unsuitable for inclusion in the study
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