EUCTR2010-018375-22-IT进行中（未招募）不适用
A randomized, double-blind, parallel group study of the safety and effect onclinical outcome of tocilizumab SC versus tocilizumab IV, in combination withtraditional disease modifying anti-rheumatoid arthritis drugs (DMARDs), inpatients with moderate to severe active rheumatoid arthritis - ND
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,200
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
- •Able and willing to give written informed consent and comply with the requirements
- •of the study protocol (e.g. willing to take oral folate at a minimum dose of 5 mg/week
- •if on MTX treatment.)
- •2. Age ?????? 18 years
- •3. Rheumatoid arthritis of ?????? 6 months duration, diagnosed according to the revised 1987
- •American College of Rheumatology (ACR; formerly American Rheumatism
- •Association) criteria, Appendix 2)
- •4. Receive treatment on an outpatient basis.
- •5. Swollen joint count (SJC) ?????? 4 (66 joint count) and tender joint count (TJC) ?????? 4 (68
- •joint count) at screening and baseline.
- •6. Prior to randomization, will have discontinued etanercept for ?????? 2 weeks, infliximab,
- •certolizumab, golimumab, abatacept or adalimumab for ?????? 8 weeks, anakinra for ?????? 1
- •7. Have received permitted DMARDs at a stable dose for at least 8 weeks prior to
- •8. At screening CRP ?????? ULN (central laboratory).
- •9. Oral corticosteroids (?????? 10 mg/day prednisone or equivalent) and NSAIDs (up to the
- •maximum recommended dose) are permitted if on a stable dose regimen for ?????? 4
- •weeks prior to baseline.
- •10. Females of childbearing potential and males with female partners of childbearing
- •potential may participate in this trial only if using a reliable means of contraception
- •(e.g. physical barrier (patient or partner), contraceptive pill or patch, spermicide and
- •barrier, or IUD).
- •11. If female of childbearing potential, the patient must have a negative pregnancy test at
- •screening and baseline visit.
- •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 randomization.
- •2. Rheumatic autoimmune disease other than RA, including SLE, MCTD, scleroderma,
- •polymyositis, or significant systemic involvement secondary to RA (e.g., vasculitis,
- •pulmonary fibrosis or Felty’s syndrome). Secondary Sj?gren’s syndrome with RA is
- •3. Functional class IV as defined by the ACR Classification of Functional Status in
- •Rheumatoid Arthritis (Appendix 3).
- •4. Diagnosis of juvenile idiopathic arthritis (JIA) or juvenile rheumatoid arthritis (JRA)
- •and/or RA before the age of 16.
- •5. Prior history of or current inflammatory joint disease other than RA (e.g., gout, Lyme
- •disease, seronegative spondyloarthropathy including reactive arthritis, psoriatic
- •arthritis, arthropathy of inflammatory bowel disease).
研究者
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