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
- 15
- 主要终点
- Percentage of Participants With Any Adverse Event (AE)
研究概览
简要总结
This open-label, single arm, multicenter long-term extension study will evaluate the safety and efficacy of tocilizumab (RoActemra/Actemra) in participants with moderate to severe rheumatoid arthritis who have completed the 104-week WA19926 core study. Eligible participants will receive 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, at baseline or later if they are in remission DAS28 at Week 104 of WA19926, according to the Investigator's assessment
- •No current or recent adverse event or laboratory finding preventing the use of the study drug dose of tocilizumab 8 mg/kg at baseline visit
- •Women of childbearing potential must agree to use adequate contraception as defined by protocol during and up to 3 months after treatment
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- •Participants who have withdrawn prematurely from the WA19926 core study for any reason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
Tocilizumab 8 milligrams per kilogram (mg/kg) administered intravenously once every 4 weeks during a minimum of 104 weeks.
干预措施: Tocilizumab (Drug)
结局指标
主要结局
Percentage of Participants With Any Adverse Event (AE)
时间窗: Up to 160 weeks
An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any AE that is fatal; life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; congenital anomaly/birth defect in a neonate/infant or significant medical event in the Investigator's judgment. AE of special interest (AESI) includes serious and/or medically significant infectious; myocardial infarction(MI) / acute coronary syndrome (ACS); gastrointestinal (GI) perforation; anaphylaxis / hypersensitivity reactions; demyelinating disorders; stroke; serious and/or medically significant bleeding events; serious and/or medically significant hepatic events; malignancies malignant.
次要结局
- Percentage of Participants With at Least One Clinical Remission Period(Up to approximately 148 weeks)
- Percentage of Participants With at Least One Drug-Free Period(Up to approximately 148 weeks)
- Cumulative Time of Remission Per Participant Over the Extension Study Period(Up to approximately 148 weeks)
- Percentage of Participants With at Least 1 Rheumatoid Arthritis (RA) Flare(Up to approximately 148 weeks)
- Time to RA Flare Following Remission or Drug-Free Remission(Up to approximately 148 weeks)
- Change From Day 1 in DAS28-ESR Scores Over Time(Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140)
- Change From Day 1 in Simplified Disease Activity Index (SDAI) Scores Over Time(Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140)
- Change From Day 1 in Tender Joint Count Based on 28 Joints (TJC28) Over Time(Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140)
- Change From Day 1 in Swollen Joint Count Based on 28 Joints (SJC28) Over Time(Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140)
- Erythrocyte Sedimentation Rate (ESR) Over Time(Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140)
- C-reactive Protein (CRP) Level(Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140)
- Participants' Global Assessment of Pain (VAS) Score(Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140)
- Participants' Global Assessment of Disease Activity (VAS) Score(Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140)
- Physicians' Global Assessment of Disease Activity (VAS) Score(Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140)
- Percentage of Participants With Health Assessment Questionnaire Disability Index (HAQ-DI) Remission(Baseline and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128 140)
- Percentage of Participants With Clinically Meaningful Improvement From Baseline in HAQ-DI(Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140)