EUCTR2008-001847-20-GR进行中（未招募）不适用
Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment.
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
- 470
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.Body weight = 150 kg
- •4.Patients currently experiencing active moderate to severe RA (DAS28 > 4.4) according to the revised 1987 ACR criteria for the diagnosis of RA at baseline. At screening the DAS28 must be equal or greater than 4.0 (DAS28 =4.0).
- •5.Patients currently receiving MTX (oral or parenteral) for at least 12 weeks and who have received MTX at a stable dose of at least 15 mg/week for at least 6 weeks prior to treatment (day 1), with the following exception: 10 mg instead of 15 mg is acceptable in patients with a body weight < 50 kg, low grade toxicity to MTX (such as nausea), or calculated glomerular filtration rate (or creatinine clearance) < 60 mL/min.
- •Patients with a history of parenteral (subcutaneous or intramuscular) MTX prior to baseline are eligible. However, prior to treatment (day 1) these patients must have been on a stable dose of oral MTX of at least 15 mg/week for at least 6 weeks.
- •6.If patients are receiving an oral corticosteroid, the dose must have been = 10 mg/day prednisone (or equivalent) and stable for at least 25 out of 28 days prior to treatment (day 1)
- •7.Patients receiving treatment on an outpatient basis
- •8.Patients 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 randomization
- •2.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). Patient with interstitial pulmonary fibrosis and still able to tolerate MTX therapy are permitted. Sjögren’s Syndrome with RA is permitted
- •3.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)
- •4.Prior history of or current inflammatory joint disease other than RA (e.g. gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease)
- •Drug-specific
- •5.Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before screening
- •6.Previous treatment with TCZ
- •7.Previous treatment with any biologic drug that is used in the treatment of RA
- •8.Any previous treatment with alkylating agents, such as cyclophosphamide or chlorambucil, or with total lymphoid irradiation
- •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
- •Laboratory analyses (at screening)
- •12.Serum creatinine > 142 µmol/L (1.6 mg/dL) in female patients and > 168 µmol/L (1.9 mg/dL) in male patients and no active renal disease
- •13.ALT (SGPT) or AST (SGOT) > 1.5 x ULN
- •14. Platelet count < 100 x 10e9/L (100,000/mm3)
- •15.Hemoglobin < 85 g/L (8.5 g/dL; 5.3 mmol/L)
- •16.WBC count < 1.0 x 10e9/L (1000/mm3), absolute neutrophil count < 1.0 x 10e9/L (1000/mm3). Patients enrolled prior to amendment based on a lower ANC threshold may continue to stay in the study, if deemed appropriate by the investigator.
- •17.Absolute lymphocyte count < 0.5 x 109/L (500/mm3)
- •18.Positive hepatitis B surface antigen or hepatitis C antibody
- •19.Total bilirubin > ULN
- •20.Triglycerides > 10 mmol/L (> 900 mg/dL) at screening (non-fasted or fasting)
研究者
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进行中（未招募）
不适用
Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ACT-RAYRheumatoid ArthritisEUCTR2008-001847-20-NLF Hoffmann-La Roche Ltd470