A MULTICENTER, OPEN-LABEL, SINGLE ARM, LONG-TERM EXTENSION STUDY OF WA19926 TO DESCRIBE SAFETY DURING TREATMENT WITH TOCILIZUMAB IN PATIENTS WITH EARLY, MODERATE TO SEVERE RHEUMATOID ARTHRITIS
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)
研究概览
简要总结
This extension study of WA19926 will assess the long-term safety and the efficacy of RoActemra/Actemra (tocilizumab) treatment in participants with rheumatoid arthritis. Participants who have completed the core study WA19926 are eligible to participate. Participants will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. The anticipated time on study drug is 104 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participants, >/=18 years of age who have completed the core study WA19926 and according to the investigator may benefit from RoActemra/Actemra treatment
- •No current or recent adverse event or laboratory finding preventing the use of the study drug dose at baseline
- •Receiving treatment on an outpatient basis
排除标准
- •Females who are pregnant
- •Participants who have prematurely withdrawn from the core study WA19926 for any reason
- •Treatment with any investigational drug since the last administration of the study drug in the core study WA19926
- •Treatment with an anti-tumor necrosis (TNF), anti-interleukin 1 agent or T-cell costimulation modulator since the last administration of the study drug in the core study WA19926
- •Immunization with live/attenuated vaccine since the last administration of the study drug in the core study WA19926
- •Diagnosis since the last WA19926 visit of rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis
- •Abnormal laboratory values
研究组 & 干预措施
RoActemra/Actemra single arm
干预措施: tocilizumab [RoActemra/Actemra] (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)
时间窗: End of Study (Week 104 or early withdrawal)
An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant. Adverse Events of Special Interest for this study were: Serious and/or medically significant infections; myocardial infarction/Acute coronary syndrome; Gastrointestinal perforation; Malignancies; Anaphylaxis/hypersensitivity reactions; Demyelinating disorders; Stroke and Serious and/or medically significant bleeding and hepatic events.
次要结局
- Number of Participants With Remission, Low, Medium, and High Disease Activity, as Measured by Disease Activity Index 28 Erythrocyte Sedimentation Rate (DAS28-ESR)(Screening and End of Study (Week 104 or early withdrawal))
- Number of Participants With Decreased, Unchanged, and Increased Swollen Joint Count (SJC)(Week 12 and Week 104)
- Number of Participants With Decreased, Unchanged, and Increased Participants Global Assessment of Disease Activity(Week 12 and Week 104)
- Health Assessment Questionnaire Disability Index (HAQ-DI)(End of Study (Week 104 or early withdrawal))
- Number of Participants With Remission, Low, Medium, and High Disease Activity, as Measured by Simplified Disease Activity Index (SDAI)(Screening and End of Study (Week 104 or early withdrawal))
- Number of Participants With Decreased, Unchanged, and Increased Tender Joint Count (TJC)(Week 12 and Week 104)
- Time to Rheumatoid Arthritis (RA) Flare(End of Study (Week 104 or early withdrawal))
- Number of Participants With Decreased, Unchanged, and Increased Participant Global Assessment of Pain(Week 12 and Week 104)