标签更改摘要
- Safety and effectiveness in pediatric patients have not been established.
- Effectiveness for the treatment of relapsing form of multiple sclerosis in pediatric patients 10 to 17 years was not established in an adequate and well-controlled clinical study in 166 patients (109 patients received once daily doses of Aubagio and 57 patients received placebo) for up to 96 weeks.
- Pancreatitis has been reported in adults in the postmarketing setting, but appears to occur at higher frequency in the pediatric population. In this pediatric study, cases of pancreatitis were reported in 1.8% (2/109) of patients who received Aubagio compared to no patients in the placebo group. All patients in the pediatric trial recovered or were recovering after treatment discontinuation and accelerated elimination procedure.
- Additionally, elevated or abnormal blood creatine phosphokinase was reported in 6.4% of pediatric patients who received Aubagio compared to no patients in the placebo group.
- Information on clinical trial.
- Postmarketing study.
学习类型
Efficacy,Safety,Pharmacokinetic,Tolerability
研究设计
Multicenter,Randomized,Placebo,Double-Blind,Parallel Group,Phase 3
国家
United States,Belgium,Bulgaria,Canada,China,Estonia,France,Greece,Israel,Lebanon,Lithuania,Macedonia,Morocco,Netherlands,Portugal,Russian Federation,Serbia,Spain,Tunisia,Turkey,Ukraine,United Kingdom