A randomized, double-masked, placebo-controlled study of the efficacy of gevokizumab in the treatment of patients with Behçet?s Disease uveitis

aboratorios Servier S.L.0 个研究点目标入组 110 人开始时间: 2012年10月2日最近更新: 2015年10月12日

适应症

试验速览

暂无简介。

•- Behçet?s disease diagnosis fulfilling the International Study Group Classification Criteria.
•- History of Behçet?s disease uveitis with ocular involvement of the posterior segment.
•- Patients with a stable backgroud treatment of oral corticosteroid and at least one immunosuppressive drug.
•- 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 95
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•- Infectious uveitis, uveitis due to causes other than Behçet?s disease.
•- Monocular vision
•- Presence of severe cataract or severe posterior capsular opacification.
•- Contraindication to mydriasis or presence of posterior synechiae.
•- Active TB disease.
•- History of severe allergic or anaphylactic reactions to monoclonal antibodies
•- History of malignancy within 5 years prior to Selection.
•- Infectious disease.
•- Known immunodeficiency.

发起方

aboratorios Servier S.L.