Study to investigate the immune response to influenza vaccine in patients with multiple sclerosis on teriflunomide treatment and using a population of patients with multiple sclerosis as a reference - TERIVA

sanofi-aventis recherche & developpement0 个研究点目标入组 120 人开始时间: 2011年5月31日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Male or female patients =18 and <60 years with relapsing forms of multiple sclerosis
•- treated for at least 6 months with 7 and 14 mg teriflunomide or
•- treated with a stable dose of IFN-ß-1 for at least 6 months
•Patients having signed the specific informed consent form for this study
•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 120
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Having concomitant infectious pathology at the time of vaccination
•MS relapse within 1 month before vaccination
•Systemic corticosteroids within 1 month before the vaccination
•Any contraindication to influenza vaccine
•Any vaccination within the last 6 months.
•Prior use of any investigational drug or participation to a clinical trial within 1 year only for patients under interferon Beta-1
•Prior or concomitant use (for a minimum of 1 year before study entry) of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate, mycophenolate, natalizumab (Tysabri®) leflunomide or fingolimod or other immunomodulator/immunosupressant in development
•Prior or concomitant use of Glatiramer acetate within 1 year before study entry
•Prior or concomitant use of intravenous immunoglobulins within 3 months before study entry
•Pregnant or breast feeding women
•Women of childbearing potential without adequate contraception

发起方

sanofi-aventis recherche & developpement