Long-term, Interventional, Open Label Extension Study Evaluating the Safety of Tocilizumab Treatment in Patients With Polyarticular-course Juvenile Idiopathic Arthritis From France Who Completed the Global, Multinational Trial (WA19977)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 7
- 主要终点
- Number of Participants With Any Adverse Events and Any Serious 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 will continue 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
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who completed visit 33 (week 104) of WA19977 study and who may benefit from study drug treatment according to the investigator's assessment
- •Patients have to receive the first RoActemra/Actemra infusion in this study at the Week 8 visit at the latest
- •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
- •Patient developed any other autoimmune rheumatic disease or overlap syndrome other than the permitted polyarticular-course Juvenile Idiopathic Arthritis (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
- •Currently active primary or secondary immunodeficiency
- •Any infections with contraindications to RoActemra/Actemra therapy according to investigator judgment
- •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 Any Adverse Events and Any Serious Adverse Events
时间窗: Approximately 2 years
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.
Number of Participants With Adverse Events of Special Interest
时间窗: Approximately 2 years
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. The AEs of special interests included gingival bleeding, tooth abscess, acarodermatitis, ear infection, gastroenteritis, herpes zoster ophthalmic, lice infestation, nasopharyngitis, oral fungal infection, oral herpes, pharyngitis, rhinitis, sinusitis, tonsillitis, tracheitis, tracheobronchitis, urinary tract infection, menorrhagia, asthma, epistaxis, and hematoma.
Number of Participants With Adverse Events Related to Tocilizumab
时间窗: Approximately 2 years
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. Relatedness of any AEs was reported as possibly related, probably related, or remotely related to TCZ.
次要结局
- Mean Duration of Study Follow-Up(Approximately 2 years)
- Number of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology Response 50/70(Weeks 12, 24, 36, 48, 60, 72, 84, and 108)
- Number of Participants Achieving Clinical Remission(Weeks 24, 36, 48, 72, and 108)
- Mean Exposure to Study Treatment(Approximately 2 years)
- Number of Participants With AEs Leading to TCZ Modification, AEs Leading to Death, Anaphylaxis or Serious Hypersensitivity and Deaths(Approximately 2 years)
- Number of Participants With Clinically Significant Abnormal Laboratory Parameters(Approximately 2 years)
- Number of Joints With Limitation of Motion(Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108)
- Number of Participants With Inactive Disease(Weeks 24, 36, 48, 72, and 108)
- Number of Painful Joints(Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108)
- Number of Participants With Abnormality in Physical Examinations(Approximately 2 years)
- Number of Joints With Active Range of Motion(Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108)
- Physician's Global Assessment of Disease Activity(Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108)
- Parent/Patient's Global Assessment of Disease Activity(Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108)
- Parent/Patient's Discomfort Index (Pain)(Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108)
- Number of Participants With a Minimally Important Improvement in the Childhood Health Assessment Questionnaire-Disability Index(Weeks 12, 24, 36, 48, 60, 72, 84, and 108)
- Number of Swollen Joints(Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108)