دورية أكاديمية
Intravenous dosing of tocilizumab in patients younger than two years of age with systemic juvenile idiopathic arthritis: results from an open-label phase 1 clinical trial
العنوان: | Intravenous dosing of tocilizumab in patients younger than two years of age with systemic juvenile idiopathic arthritis: results from an open-label phase 1 clinical trial |
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المؤلفون: | Navita L. Mallalieu, Sunethra Wimalasundera, Joy C. Hsu, Wendy Douglass, Chris Wells, Inmaculada Calvo Penades, Ruben Cuttica, Hans-Iko Huppertz, Rik Joos, Yukiko Kimura, Diana Milojevic, Margalit Rosenkranz, Kenneth Schikler, Tamas Constantin, Carine Wouters |
المصدر: | Pediatric Rheumatology Online Journal, Vol 17, Iss 1, Pp 1-10 (2019) |
بيانات النشر: | BMC, 2019. |
سنة النشر: | 2019 |
المجموعة: | LCC:Pediatrics LCC:Diseases of the musculoskeletal system |
مصطلحات موضوعية: | Biological therapy, Inflammation, Juvenile idiopathic arthritis, Pharmacokinetics, Pediatrics, RJ1-570, Diseases of the musculoskeletal system, RC925-935 |
الوصف: | Abstract Background The anti–interleukin-6 receptor-alpha antibody tocilizumab was approved for intravenous (IV) injection in the treatment of patients with systemic juvenile idiopathic arthritis (sJIA) aged 2 to 17 years based on results of a randomized controlled phase 3 trial. Tocilizumab treatment in systemic juvenile idiopathic arthritis (sJIA) patients younger than 2 was investigated in this open-label phase 1 trial and compared with data from the previous trial in patients aged 2 to 17 years. Methods Patients younger than 2 received open-label tocilizumab 12 mg/kg IV every 2 weeks (Q2W) during a 12-week main evaluation period and an optional extension period. The primary end point was comparability of pharmacokinetics during the main evaluation period to that of the previous trial (in patients aged 2–17 years), and the secondary end point was safety; pharmacodynamics and efficacy end points were exploratory. Descriptive comparisons for pharmacokinetics, pharmacodynamics, safety, and efficacy were made with sJIA patients aged 2 to 17 years weighing |
نوع الوثيقة: | article |
وصف الملف: | electronic resource |
اللغة: | English |
تدمد: | 1546-0096 02982439 |
Relation: | http://link.springer.com/article/10.1186/s12969-019-0364-z; https://doaj.org/toc/1546-0096 |
DOI: | 10.1186/s12969-019-0364-z |
URL الوصول: | https://doaj.org/article/7f02982439724267a0d9a1e6ca5fa34f |
رقم الأكسشن: | edsdoj.7f02982439724267a0d9a1e6ca5fa34f |
قاعدة البيانات: | Directory of Open Access Journals |
تدمد: | 15460096 02982439 |
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DOI: | 10.1186/s12969-019-0364-z |