EUCTR2009-012218-30-PT进行中（未招募）不适用
A randomized, double-blind, placebo-controlled study to assess the efficacy of tocilizumab (TCZ) + non-biological DMARD in reducing synovitis as measured by magnetic resonance imaging (MRI) at 12 weeks after initiation of treatment in patients with moderate to severe rheumatoid arthritis (RA) with inadequate response to non-biological DMARDs - PORTRAIT
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Male or non-pregnant, non-nursing female
- •= 18 years of age
- •Diagnosis of RA of =6 months duration and moderate to severe disease activity defined as a DAS28 > 3.2 at screening
- •Synovitis in the wrist of the dominant hand (defined as the presence of swollen and tender wrist joint and confirmed by MRI screening)
- •Receiving treatment on an outpatient basis
- •Patients on = 1 non-biologic DMARDs at a stable dose for a period = 12 weeks prior to treatment (baseline)
- •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)
- •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
- •Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
- •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)
- •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)
- •Prior history of or current inflammatory joint disease other than RA (e.g. gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease)
- •Patient with interstitial pulmonary fibrosis and still able to tolerate MTX therapy are allowed
- •Sjögren’s Syndrome with RA is allowed
- •Treatment with any investigational agent or with anakinra, calcineurin inhibitors (e.g. tacrolimus or cyclosporine), mycophenolate mofetil or mycophenolic acid sodium within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before screening
- •Previous treatment with any cell-depleting therapies, including investigational agents (e.g. CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19 and anti-CD20)
- •Previous treatment with abatacept
- •Previous treatment with anti-TNF
- •Treatment with leflunomide in combination with MTX
- •Treatment with IV gammaglobulin, plasmapheresis or Prosorba® column within 6 months before baseline
- •Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
- •Intraarticular corticosteroids on dominant hand to be imaged within 6 months prior to baseline
- •Immunization with a live/attenuated vaccine within 4 weeks prior to baseline
- •Previous treatment with TCZ (an exception to this criterion may be granted for single-dose exposure upon application to the sponsor on a case by case basis)
- •Any previous treatment with alkylating agents, such as cyclophosphamide or chlorambucil, or with total lymphoid irradiation
- •Any previous treatment with a biologic agent for RA
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