Long-term, Interventional, Open Label Extension Study Evaluating the Safety of Tocilizumab Treatment in Patients With Polyarticular-course Juvenile Idiopathic Arthritis Who Completed the Global, Multinational Trial (WA19977)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 6
- 主要终点
- Number of Participants With Adverse Events of Special Interest and Study-Drug Related Adverse Events
研究概览
简要总结
This long-term, open-label extension study will evaluate the safety of RoActemra/Actemra (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who completed the WA19977 core study. Patients aged 9-18 years with at least JIA ACR30 clinical response to RoActemra/Actemra in the core study will be eligible to receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. Anticipated time on study treatment is 104 weeks.
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
- 9 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 9 to 18 years of age who completed visit 33 (week 104) of WA19977 study with at least JIA ACR30 clinical response to RoActemra/Actemra relative to baseline in WA19977, with no AEs, SAEs or conditions that lead to unacceptable risk of continued treatment
- •Scheduled to receive first RoActemra/Actemra infusion in this study between 4 and 6 weeks after the last IV infusion in the core study
- •Females of child-bearing potential and males with female partners of child-bearing potential must agree to use effective contraception as defined by protocol
排除标准
- •Patients with, according to investigator judgment, not satisfactory benefit from RoActemra/Actemra therapy within WA19977
- •Treatment with any investigational agent since the last administration of study drug in the core study WA19977 or current participation in another clinical trial except WA19977
- •Patient developed any other autoimmune rheumatic disease or overlap syndrome other than the permitted polyarticular-course JIA subsets: rheumatoid factor positive or negative JIA or extended oligoarticular JIA
- •Patient is pregnant , lactating, or intending to become pregnant during the study and up to 12 weeks after the last administration of study drug
- •Any significant concomitant disease or medical or surgical condition
- •History of significant allergic or infusion reactions to prior biologic therapy
- •Known current active acute, subacute, chronic or history of recurrent infection; patients suffering from ongoing active infections with Epstein Barr virus, herpes zoster or recurrent history of urinary tract infection can be included after the (acute) infection has been excluded or subsided
- •Positive for latent tuberculosis (TB)
- •Currently active asthma for which the patient has required the use of oral or parenteral corticosteroids for >/= 2 weeks within 6 months prior to entering the study
- •Inadequate hepatic, renal or bone marrow function
研究组 & 干预措施
RoActemra/Actemra
干预措施: tocilizumab [RoActemra/Actemra] (Drug)
结局指标
主要结局
Number of Participants With Adverse Events of Special Interest and Study-Drug Related Adverse Events
时间窗: Baseline and every 4 weeks up to Week 76 and Final Follow-Up Visit (up to 82 weeks)
Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first day of tocilizumab administration until 4 weeks after administration of the last dose of tocilizumab. AEs of special interest were Infections (including all opportunistic infections and non-serious infections as defined by those treated with IV anti-infectives), Myocardial infarction/Acute coronary syndrome, Gastrointestinal perforations and related events, Malignancies, Anaphylaxis/Hypersensitivity reactions, Demyelinating disorders, Stroke. Bleeding events, Hepatic events and Macrophage activation syndrome (MAS).
Number of AEs of Special Interest and Study Drug Related AEs
时间窗: Baseline and every 4 weeks up to Week 76 and Final Follow-Up Visit (up to 82 weeks)
AEs and SAEs were recorded from the first day of tocilizumab administration until 4 weeks after administration of the last dose of tocilizumab.
次要结局
- CHAQ-DI Score(Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72, and Final Follow-Up Visit (up to 82 weeks))
- Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit(Baseline, Weeks 12, 24, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks))
- Percentage of Participants With Inactive Disease by Visit(Baseline, Weeks 12, 24, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks))
- Percentage of Participants Achieving Clinical Remission (CR) at Each Visit(Baseline, Screening, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76 and Final Follow-Up Visit (up to 82 weeks))
- Physicians Assessment of Global Activity (VAS)(Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks))
- Parent or Participant's Assessment of Global Activity (VAS)(Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks))
- Number of Joints With Active Arthritis(Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks))
- Number of Joints With Lack of Motion(Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks))
- Erythrocyte Sedimentation Rate(Baseline, Weeks 4, 8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76 and Final Follow-Up Visit (up to 82 weeks))
- Parent or Participant's Assessment of Pain (VAS)(Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72, and Final Follow-Up Visit (up to 82 weeks))
- CRP Levels(Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76 and Final Follow-Up Follow-Up Visit (up to 82 weeks))