Open-label, Multicenter, Randomized, Parallel Study to Investigate pk, pd, Efficacy and Safety of Tocilizumab (TCZ, RO4877533) Following Subcutaneous Administration of TCZ 162 mg Weekly or Every Other Week in Combination With Methotrexate in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 主要终点
- Pharmacokinetics of TCZ after QW or Q2W sc administration
研究概览
简要总结
This open-label randomized 2arm study will investigate the pharmacokinetics, pharmacodynamics, efficacy and safety of subcutaneously administered tocilizumab in patients with rheumatoid arthritis who have shown an inadequate response to methotrexate. Patients will be randomized to receive tocilizumab 162 mg sc either weekly or every other week, in combination with methotrexate, for 12 weeks. Assessments will be made at regular intervals during treatment and on the 3 weeks of follow-up.Target sample size is < 50 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults 18 - 75 years of age
- •active rheumatoid arthritis of >/= 6 months duration
- •inadequate response to at least 12 weeks of methotrexate, the last 8 prior to baseline on stable dose
- •swollen joint count (SJC)>/=4, tender joint count (TJC)>/=6 at screening and baseline
- •DMARDs and anti-TNFs, other than methotrexate, withdrawn prior to baseline
- •oral corticosteroids (</= 10mg/day prednisone or equivalent) and NSAIDS on stable dose </= 4 weeks prior to baseline
排除标准
- •rheumatic autoimmune disease other than rheumatoid arthritis
- •prior history or current inflammatory joint disease other than rheumatoid arthritis
- •major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
- •functional class IV by ACR classification
研究组 & 干预措施
1
干预措施: folic acid (Drug)
1
干预措施: methotrexate (Drug)
1
干预措施: tocilizumab [RoActemra/Actemra] (Drug)
2
干预措施: folic acid (Drug)
2
干预措施: methotrexate (Drug)
2
干预措施: tocilizumab [RoActemra/Actemra] (Drug)
结局指标
主要结局
Pharmacokinetics of TCZ after QW or Q2W sc administration
时间窗: multiple sampling after 1st and last dose, weeks 1 and 12, at bi-weekly intervals during treatment and twice on follow-up
Pharmacodynamic responses of CRP
时间窗: sampling in weeks 1 and 2 and at weekly or bi-weekly intervals throughout treatment
Safety and tolerability, including injection site reaction
时间窗: laboratory assessments every 2nd week on treatment and after 3 weeks follow-up, injection site evaluation after 1st, 2nd and last injection.
次要结局
- Efficacy according to ACR and DAS-EULAR parameters(assessments on day 1 of weeks 1, 4, 8 and 12)
- PD responses of IL-6, sIL-6R and anti TCZ antibody(multiple sampling after 1st and last dose, weeks 1 and 12, at bi-weekly intervals during treatment and twice on follow-up)