EUCTR2009-011105-17-IT进行中（未招募）不适用
A single-arm, open-label study of early improvement of anemia and fatigue during treatment with tocilizumab (TCZ) in combination with non biologic DMARDs, in adult patients with moderate to severe active rheumatoid arthritis. - Anemia Fatigue
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- ROCHE
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male or non-pregnant, non-nursing female 2.Age > 18 years 3.Patients currently experiencing moderate to severe active RA (DAS-28 > 3.2) at screening. 4.Patients receiving treatment on an outpatient basis 5.Patients that have responded inadequately to prior treatment with a stable dose (> 8 weeks) of non biologic DMARDs therapy 6.Oral corticosteroids and NSAIDs (up to the maximum recommended dose) are permitted if the dose has been stable for at least 4 weeks prior to baseline 7.Subjects able and willing to give written informed consent and comply with the requirements of the study protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Disease-specific criteria: 1. Rheumatic autoimmune disease other than RA, including systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis, or significant systemic involvement secondary to RA (e.g. vasculitis, pulmonary fibrosis or Felty?s syndrome). Patients with secondary Sjogren?s Syndrome associated with RA can be included in the study 2. Functional class IV as defined by the ACR Classification of Functional Status in RA (largely or wholly incapacitated with patient bedridden or confined to wheel chair, permitting little or no self-care) 3. History of or current inflammatory joint disease other than RA (including but limited to: tophaceous gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease, pseudogout, arthropathy of inflammatory bowel disease) Drug-specific criteria: 4. Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before screening 5. Previous treatment with an anti-TNF agent 6. Previous/concurrent treatment with any cell depleting therapies, including investigational agents (e.g. alemtuzumab, anti-CD4, anti-CD5, anti-CD3, anti-CD19) 7. Treatment with intravenous gamma globulin, plasmapharesis or Prosorba column within six months of baseline 8. Concurrent treatment with EPO 9. Immunization with a live/attenuated vaccine within 4 weeks prior to baseline 10. Any previous treatment with alkylating agents, such as cyclophosphamide or chlorambucil, or with total lymphoid irradiation Laboratory-specific criteria (at screening): 11. Serum creatinine > 1.6 mg/dL (160 μmol/L) 12. ALT (SGPT) or AST (SGOT) > 1.5 ULN (if initial sample yields ALT [SGPT] or AST [SGOT] > 1.5 ULN, a second sample may be taken and tested during the screening period) 13. Platelet count < 100 x 109/L (100,000/mm3) 14. Hemoglobin < 80 g/L (8 g/dL) 15. WBC count < 1.0 x 109/L (1000/mm3) and/or ANC < 1.0 x 109/L (1000/mm3) and/or ALC < 0.5 x 109/L (500/mm3) 16. Total bilirubin > 1.5 ULN (if initial sample yields bilirubin > 1.5 ULN, a second sample may be taken and tested during the screening period) 17. Triglycerides > 900 mg/dl at screen (non-fasted) 18. Positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody General medical: 19. Pregnant women or nursing (breastfeeding) mothers 20. Females of child-bearing potential who are not using a reliable means of contraception 21. Intended major surgery within 8 weeks prior to screening or planned major joint surgery during the study 22. Body weight > 150 kg 23. History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies 24. Evidence of significant and/or uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders 25. In patients with a history of diverticulitis or diverticulosis requiring antibiotic treatment, the treating physician needs to consider the benefit-risk ratio 26. A history of chronic ulcerative lower GI disease such as Crohn?s disease, ulcerative colitis or other symptomatic lower GI conditions that might predispose to perforations 27. Uncontrolled disease states, such as asthma, psoriasis or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids Et al.
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