EUCTR2013-005212-98-GB进行中（未招募）1 期
ONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH POLYARTICULAR-COURSE AND SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 104
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- Completion of either of the JIGSAW studies, study WA28117 (for patients with pcJIA) or study WA28118 (for patients with sJIA)
- •- Adequate disease control with the use of SC TCZ, as assessed by the investigator
- •- Written informed consent for study participation obtained from the patient (for patients >/= 18 years old) or the patient's parents or guardian, with assent as appropriate by the patient, depending on the level of the patient's understanding
- •- Receipt of the baseline dose of TCZ in this long-term extension study should occur on the same day as the withdrawal visit 1 in the respective JIGSAW study (however, this is not a requirement for participation in this study and patients are still eligible for participation even though they may not immediately transition into the study)
- •- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 6 months after the last dose of TCZ
- •- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm during the treatment period and for at least 6 months after the last dose of TCZ
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 104
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •- Prior discontinuation of intravenous (IV) TCZ because of inadequate clinical response or safety events (including hypersensitivity)
- •- Therapy with biologic agents (except TCZ) in the period between completion of the JIGSAW study and screening for the current study
- •- Concurrent treatment with disease-modifying anti-rheumatic drugs (including methotrexate ), nonsteroidal anti-inflammatory drugs, and oral corticosteroids is permitted at the discretion of the investigator
- •- Use of live or attenuated vaccines and immunosuppressants, such as cyclosporine and cyclophosphamide, is prohibited
- •- Pregnancy or breast-feeding
- •- Any significant concurrent medical or surgical conditions or findings that would jeopardize the patients safety or ability to complete the study, including but not limited to disease of the nervous, renal, hepatic, cardiac, pulmonary, gastric, or endocrine system or any infection
- •- History of alcohol, drug, or chemical abuse within 6 months prior to screening
- •- History of atypical tuberculosis (TB) or active TB requiring treatment within 2 years prior to screening
研究者
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