NCT01347983已完成3 期
Extension Study of Tocilizumab Long Term Treatment of Moderate to Severe Rheumatoid Arthritis Patients
Chugai Pharma Taiwan16 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2011年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 16
- 主要终点
- Proportion of patients with an American College of Rheumatology 70 (ACR70) response
研究概览
简要总结
24 week open-labeled extension study to continue monitoring the same group of patients in the previous MRA230TW phase IIIb trial in order to evaluate the long term efficacy and safety of tocilizumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who had completed at least 5 out of the 7 visits scheduled for weeks 2, 4, 8, 12, 16, 20 and 24 in the tocilizumab Phase IIIb study(MRA230TW).
- •Patients assigned in the Phase IIIb study(MRA230TW), who had received scheduled dose for at least 16 weeks but still failed to achieve adequate treatment response characterized by ACR20
排除标准
- •Patients who have received a major surgery including joint surgery 8 weeks prior to the screening or are scheduled to be operated within 6 months after the enrolment.
- •Patients with rheumatoid autoimmune disease other than RA, including but not limited to SLE(system lupus erythematosus), or significant systemic involvement secondary to RA.
- •Patients who belong to the Class IV of the ACR classification criteria for functional status of RA. (ACR Amended Criteria for the Classification of Functional Capacity in Rheumatoid Arthritis; Class IV: Largely or wholly incapacitated with patient bedridden or confined to wheel chair, permitting little or no self-care).
- •Patients with a history of hypersensitivity to human, humanized or murine monoclonal antibodies or patients with contraindication for them.
- •Patients who currently have or have a history of recurrence of bacterial, viral,fungal, or mycobacterial infections or other infectious diseases; tuberculosis(TB),atypical mycobacterial disease, clinically significant granulomatous disease on chest radiograph, hepatitis B, hepatitis C, or herpes zoster and etc. However, a patient with hand & foot fungal infections can participate.
结局指标
主要结局
Proportion of patients with an American College of Rheumatology 70 (ACR70) response
时间窗: at week 24
次要结局
- Proportion of patients with ACR50 response(at week 24)
- Proportion of patients with ACR20 response(at week 24)
- Mean change from baseline of Swollen joint count(SJC) and Tender joint count(TJC) respectively(at baseline and week 24)
- Mean change from baseline in disease activity using 28-joint modified disease activity score (DAS28)(at baseline and week 24)
- Proportion of patients achieving DAS28 remission (DAS28 < 2.6)(at week 24)
- Adverse event incidence(from baseline to week 24)
- Mean change from baseline to evaluation visits in vital signs(from baseline to week 24)
- Change in Electrocardiogram. From baseline to evaluation visits(from baseline to week 24)
- Mean change from baseline visit to evaluation visits in quantitative hematological exam results.(from baseline to week 24)
- Mean change from baseline visit to evaluation visits in quantitative Biochemical exam of blood results.(from baseline to week 24)
- Mean change from baseline visit to evaluation visits in quantitative serum lipid exam results.(from baseline to week 24)
- Mean change from baseline visit to evaluation visits in quantitative urinalysis results.(from baseline to week 24)
研究者
研究点 (16)
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