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
- 49
- 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 open-label, single arm, multicenter long-term extension study of WA19926 evaluated the safety and efficacy of tocilizumab (RoActemra/Actemra) in participants with moderate to severe rheumatoid arthritis who completed the 104-week WA19926 core study. Eligible patients received tocilizumab 8 mg/kg intravenously every 4 weeks for up to 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
- •Participants who complete their last WA19926 core study visit (Week 104) and who may benefit from study drug treatment according to the Investigator's assessment
- •No current or recent adverse event or laboratory finding preventing the use of the study drug dose of RoActemra/Actemra 8 mg/kg at baseline visit
- •Women of childbearing potential must agree to use adequate contraception as defined by protocol during the treatment period
排除标准
- •Pregnant females
- •Participants who have withdrawn prematurely from the WA19926 core study for any reason
- •Treatment with any investigational agent or cell-depleting therapies since the last administration of study drug in WA19926
- •Treatment with an anti-tumor necrosis factor (TNF) or anti-interleukin (IL) 1 agent, or a T-cell costimulation modulator since the last administration of study drug in WA19926
- •Immunization with a live/attenuated vaccine since the last administration of study drug in WA19926
- •Diagnosis since last WA19926 visit (Week 104) of rheumatic autoimmune disease other than rheumatoid arthritis
- •Diagnosis since last WA19926 visit (Week 104) of inflammatory joint disease other than rheumatoid arthritis
- •History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, including tocilizumab and its excipients
- •Evidence of severe uncontrolled concomitant disease or disorder
- •Known active or history of recurrent infections
- •Active tuberculosis requiring treatment in the previous 3 years
- •History of alcohol, drug or chemical abuse since inclusion in the WA19926 study
研究组 & 干预措施
Tocilizumab
干预措施: Tocilizumab (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: Up to 112 weeks
An AE is any untoward medical occurrence in a study participant given administered a pharmaceutical product, regardless of the cause of the AE. 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. AESIs included serious infections (including opportunistic infections) and abnormal liver function tests.
Percentage of Adverse Events (AEs) Leading to Dose Modification and AEs Leading to Study Withdrawal
时间窗: Up to 112 weeks
An AE is any untoward medical occurrence in a study participant given administered a pharmaceutical product, regardless of the cause of the AE.
Percentage of Adverse Events With Severity as Mild, Moderate, and Severe
时间窗: Up to 112 weeks
次要结局
- Percent Change From Baseline in the Disease Activity Index 28 Erythrocyte Sedimentation Rate (DAS28-ESR) Over Time(Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92 and 104)
- Percent Change From Baseline in the Simplified Disease Activity Index (SDAI) Over Time(Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92 and 104)
- Change From Baseline in Swollen Joint Count 66 (SJC 66) Over Time(Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92 and 104)
- Percent Change in Participant's Assessment of Pain (VAS) Over Time(Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92 and 104)
- Change From Baseline in Health Assessment Questionnaire (HAQ-DI) Score Over Time(Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92 and 104)
- Change From Baseline in Tender Joint Count 66 (TJC 66) Over Time(Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92 and 104)
- Percentage of Participants With Treatment-Free Remission According to DAS28-ESR/SDAI Remission Criteria(Up to 104 weeks)
- Time to Rheumatoid Arthritis Recurrence in Participants Who Achieved Treatment-Free Remission(Up to 104 weeks)
- Percent Change in Participant's General Assessment of Disease Activity (Severity of Disease) VAS Over Time(Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92 and 104)