EUCTR2008-000587-17-BE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 - ACT-Sure
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 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 disease, clinically significant abnormalities on CXR as determined by the investig
研究者
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