ACTRN12608000397314已完成3 期
Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab versus Tocilizumab plus Non-biologic disease modifying antirheumatic drugs in Patients with Active Rheumatoid Arthritis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 70
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 /A（—）
- 性别
- All
入选标准
- •1.Male or non-pregnant, non-nursing female
- •2.>/-18 years of age
- •3.Diagnosis of moderate to severe active RA (DAS28>/-3.2) of >/- 6months duration
- •4.Receiving treatment on an outpatient basis
- •5.Patients on >/-1 non-biologic DMARDs at a stable dose for a period 6. Patients with an 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 (Day1)
- •8.Able and willing to give written informed consent and comply with the requirements of the study protocol
排除标准
- •1.Major surgery (incl joint surgery) within 8weeks prior to screening or planned major surgery within 6months following randomisation
- •2.Rheumatic autoimmune disease other than RA (rheumatoid arthritis), including systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis, or significant systemic involvement secondary to RA(rheumatoid arthritis) (e.g.vasculitis, pulmonary fibrosis or Felty's syndrome)
- •Patient with interstitial pulmonary fibrosis and still able to tolerate MTX (methotrexate) therapy are permitted
- •Sjorgen's Syndrome with RA (rheumatoid arthritis) is permitted
- •3. Functional Clas IV as defined by the ACR (American College of Rheumatology) Classification of Functional Status in RA (rheumatoid arthritis) (largely or wholly incapacitated with patient bedridden or confined to wheel chair, permitting little or no self-care)
- •4.Prior history of or current inflammatory joint disease other than RA (rheumatoid arthritis) (e.g. gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropaty, Lyme disease)
- •5.Treatment with any investigational agent within 4weeks (or 5 half-lives of investigational agent, whichever is longer) before screening.
- •6.Previous treatment with any cell-depleting therapies, including investigational agents (e.g. CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19 and anti-CD20)
- •7.Previous treatment with abatacept
- •8.Treatment with IV gamma globulin, plasmapheresis or Prosorba column within 6months before baseline
- •9.Intraarticular or parenteral corticosteroids within 6weeks prior to baseline
- •10.Immunization with a live/attenuated vaccine within 4weeks prior to baseline
- •11.Previous treatment with TCZ (Tocilizumab) (an exception to this criterion may be granted for single-dose exposure upon application to the sponsor on a case by case basis)
- •12.Any previous treatment with alkylating agents, such as cyclophosphamide or chlorambucil, or with total lymphoid irradiation
- •13.Serum creatinine >142
研究者
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