EUCTR2008-000587-17-FI进行中（未招募）不适用
Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,500
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. = 18 years of age
- •3. Diagnosis of active RA of = 6 months duration and moderate to severe disease activity defined as DAS28 > 3.2 at screening
- •4. Receiving treatment on an outpatient basis
- •5. Patients on = 1 non-biologic DMARDs and/or anti-TNF therapy (see section 6.1) at a stable dose for a period = 8 weeks at any time prior to treatment (baseline)
- •6. Patients with inadequate clinical response to a stable dose of non-biologic DMARD or anti-TNF therapy
- •7. If patients are receiving an oral corticosteroid, the dose must have been stable for at least 25 out of 28 days prior to treatment (baseline)
- •8. 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
- •1. Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
- •2. Rheumatic autoimmune disease other than RA, Sjögren’s Syndrome with RA is permitted
- •3. Functional class IV as defined by the ACR Classification of Functional Status
- •4. Prior history of or current inflammatory joint disease other than RA
- •Drug-specific
- •5. Treatment with any investigational agent or with anakinera, calcineurin inhibitors, mycophenolate, mofetil or mycophenolic acid within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before screening
- •6. Previous treatment with any cell-depleting therapies
- •7. Previous treatment with abatacept
- •8. Treatment with IV gamma globulin, plasmapheresis or Prosorba® column within 6 8. Treatment with leuflunomide in combination with MTX.
- •9. Treatment with IV gamma globulin, plasmapheresis or Prosorba® column within 6 months before baseline
- •10. Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
- •11. Immunization with a live/attenuated vaccine within 4 weeks prior to baseline
- •12. Previous treatment with TCZ (exception may be granted for single-dose exposure on a case by case basis)
- •13. Any previous treatment with alkylating agents
- •Laboratory analyses (at screening)
- •14. Serum creatinine > 124 µmol/L (1.4 mg/dL) in female patients and > 141 µmol/L (1.6 mg/dL) in male patients
- •15. 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)
- •16. Platelet count < 100 x 10(9)/L (100,000/mm3)
- •17. Hemoglobin < 85 g/L (8.5 g/dL; 5.3 mmol/L)
- •18. WBC count < 1.0 x 10(9)/L (3000/mm3), ANC < 0.5 x 10(9)/L (500/mm3)
- •19. ANC < 1 x 10(9)/L (1000/mm3)
- •20. Positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody
- •21. Total bilirubin > ULN (If initial sample yields bilirubin > ULN, a second sample may be taken and tested during the screening period)
- •22. Triglycerides > 10 mmol/L (> 900 mg/dL) at screening (non-fasted)
- •General medical
- •23. Pregnant women or nursing (breastfeeding) mothers
- •24. Females of child-bearing potential who are not using a reliable means of contraception, e.g. physical barrier (patient and partner), contraceptive pill or patch, spermicide and barrier, or IUD
- •25. History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
- •26. CXR evidence of any clinically significant abnormality
- •27. Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus) or GI disease
- •28. In patients with a history of diverticulitis or diverticulosis requiring antibiotic treatment, the treating physician needs to consider the benefit-risk ratio
- •29. 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
- •30. Uncontrolled disease states where flares are commonly treated with oral or parenteral corticosteroids
- •31. Current liver disease as determined by principal investigator. Patients with prior history of ALT (SGPT) elevation are not excluded
- •32. Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (including but not limited to tuberculosis and atypical mycobacterial d
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