A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy of gevokizumab 60mg subcutaneously every 4 weeks over 24 weeks in the treatment of patients with polymyositis, dermatomyositis or necrotizing autoimmune myophaty disease

Institut de Recherches Internationales Servier (IRIS)0 个研究点目标入组 40 人开始时间: 2013年6月12日最近更新: 2015年12月22日

适应症

试验速览

暂无简介。

•- Active polymyositis or dermatomyositis or necrotizing autoimmune myophaty intolerant or resistant or dependent to systemic oral corticosteroids,
•- Disease diagnosis duration =10 years,
•- With a stable background treatment of oral corticosteroid if any and / or a stable dose of immunosuppressive agent if any.
•- Male or female, age = 18 (or legal age of majority in the country),
•- Weight = 40 kg and = 125 kg 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 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•- Juvenile dermatomyositis, drug induced myositis, severity criteria such as severe cardiovascular or pulmonary involvement or myositis damage, congenital myophathy, necrotizing myopathy, inclusion body myositis, cancer- associated myositis or DM diagnosed for less than 1 year,
•- Impossibility to perform muscle biopsy for PM and DM sine dermatitis and NAM patients (if required),
•- Non-ambulatory patients,
•- Fibromyalgia of type I,
•- Joint disease or other musculoskeletal condition,
•- Active TB disease,
•- History of severe allergic or anaphylactic reactions to monoclonal antibodies,
•- History of malignancy within 5 years prior to selection,
•- Known immunodeficiency,
•- Infectious disease,
•- Pregnancy, breastfeeding or possibility to become pregnant during the study

发起方

Institut de Recherches Internationales Servier (IRIS)