ACTRN12606000041550已完成2 期
A multicentre, double blind, parallel group, phase IIa clinical trial to assess the efficacy and safety of Cpn10 administered as twice weekly intravenous injections in subjects with rheumatoid arthritis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- CBio Limited
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •1. Fulfils the 1987 American College of Rheumatology (ACR) criteria for Rheumatoid Arthritis2. Onset of RA after 18 years of age3. Disease duration of at least 6 months4. Stable dose of DMARD, including hydroxychloroquine, sulphasalazine or methotrexate for at least 3 months prior to screening. Patients taking more than one DMARD are allowed entry into the trial but these patients cannot be taking more than one immunosuppressive drug. Patients using leflunomide and another immunosuppressive may be considered for trial inclusion, however, leflunomide must be washed out with cholestyramine for 11 days. These patients may only be enrolled at least 30 days after the last dose of cholestyramine.5. Active RA defined as 8 tender joints of the 68 examined and 8 swollen joints of 66 examined, ESR greater than or equal to 28 mm/hour, OR CRP greater than or equal tp 10 mg/L, OR morning stiffness greater than or equal to 45minutes.6. ACR functional class I-III7. Male or female aged 18-75 years and generally in good health as determined by medical history, physical examination, vital signs, ECG and routine laboratory tests at screening8. Body weight < 120kg9. Able and willing to comply with the study protocol.10. Negative serum pregnancy test taken at screening in all women except those surgically sterile or are at least 2 years postmenopausal. 11. Sexually active women of child bearing potential must agree to use a medically reliable method of preventing conception for the duration of the study, unless surgically sterile or post menopausal. 12. Sexually active men whose partners are of childbearing potential must agree to use a medically reliable method of preventing conception for the duration of the study, unless surgically sterile.13. Have provided written informed consent to participate in the trial.14. DAS 28 > 3.2 at screening.
排除标准
- •1. Stable dose of DMARD, including hydroxychloroquine, sulphasalazine or methotrexate for at least 3 months prior to screening. Patients taking more than one DMARD are allowed entry into the trial but these patients cannot be taking more than one immunosuppressive drug. Patients using leflunomide and another immunosuppressive may be considered for trial inclusion, however, leflunomide must be washed out with cholestyramine for 11 days. These patients may only be enrolled at least 30 days after the last dose of cholestyramine.2. Treatment with an investigational agent within 3 months prior to screening 3. Prior treatment with anti-TNF-alpha agents 4. Treatment with more than one NSAID within 4 weeks prior to screening.5. Dose of NSAID greater than the maximum recommended dose in the product information. 6. Current use of narcotic analgesics other than codeine at the screening visit. 7. Current use of more than 10 mg/day of prednisone or equivalent.8. Treatment with intra-articular corticosteroid injection within 3 weeks prior to screening.9. Patients with active or latent bacterial, fungal or viral infections at the time of screening 10. History of malignancy within the past 5 years (other than basal cell carcinoma or adequately treated carcinoma-in-situ of the cervix).11. Receipt of any live (attenuated) vaccines within 4 weeks before screening visit.12. Significant concurrent medical diseases including metabolic, haematologic, cardiac, renal, hepatic, infectious, psychiatric or gastrointestinal conditions which in the opinion of the Investigator places the patient at unacceptable risk for participation in the study.13. Liver function abnormality (SGOT/AST, SGPT/ALT: > 2 x upper limit of normal) or clinical evidence of hepatic insufficiency; liver cirrhosis or fibrosis. 14. History of any viral hepatitis within 1 year prior to screening or history of any drug-induced liver injury at any time prior to screening.15. Have a seropositive test to HIV, Hepatitis B or Hepatitis C at screening.16. Renal disease (creatinine level > 175 umol/L).17. Leukopenia (white blood cells < 3500 x 10^6/L).18. Thrombocytopenia (platelets < 125 x 10^9/L).19. Haemoglobin < 84 g/L (5.2 mmol/l).20. Have a history of active tuberculosis confirmed by a chest X-ray and Quantiferon TB gold testing at screening.
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