A safety open-label study of Gevokizumab in the treatment of patients with chronic non-infectious Uveitis disease, an eXtension study. The EYEGUARD-X study.

Institut de Recherches Internationales Servier0 个研究点目标入组 300 人开始时间: 2014年8月7日最近更新: 2015年12月14日

适应症

试验速览

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•- either completed participation to one of the following : CL3-78989-002 double masked period or open label extension, or X052130/CL3-78989-005 double masked period or open label period, or X052131/CL3-78989-006 double masked period or open label period, or currently benefiting from gevokizumab compassionate use after participation in gevokizumab uveitis studies,
•- Able to receive the first injection of gevokizumab within 6 weeks after the last study drug administration. In some exceptional cases when the time period since last study drug administration in previous studies is more than 6 weeks, patients should be considered in the investigator's opinion in stable ophtalmological conditions at the inclusion visit.
•- Male or female, age =18 (or legal age of majority in the country) at selection
•- For subjects with reproductive potential, a willingness to use highly effective contraceptive measures
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 270
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•- Meeting criteria for discontinuation of any of gevokizumab uveitis previous study.
•- Infectious uveitis and masquerade syndrome.
•- History of severe allergic or anaphylactic reaction to study drug administration during previous study or to gevokizumab or any of its excipient.
•- Currently active Infectious disease.

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