Randomized open label controlled trial to study Safety and Effect of itolizumab (antiCD6) in Relapsing Remitting Multiple Sclerosis.

Center of Molecular Immunology (CIM)0 个研究点目标入组 40 人开始时间: 2015年5月22日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Open. Control group: Active. Assignment: Parallel. Purpose: Treatment

•1. Able and willing to give written informed consent.
•2.Diagnosis of RRMS, as defined by revised Mc Donald Criteria.
•3.MS for at least 1 year.
•4.Currently on treatment with interferon beta-1b (IFNß) within 12 month before randomization.
•5.Active RRMS, defined by:
•= 1 clinical relapse, at 12 previous months on treatment with IFNß.
•= 1 gadolinium-enhancing lesión by magnetic resonance imaging (MRI) scans, at baseline.
•= 1 new T2-hyperintense lesions or FLAIR, compared with previous MRI scans
•6.Clinical stability within 30 days before randomization (without steroids).
•7.Expanded Disability Status Scale (EDSS) 0 - 5, at baseline.
•8.Normal laboratory values at screening:
•–Hemoglobin-men = 12.0 g/dl, women = 11.0 g/dl; Leucocytes > 5x109 L, Platelets count >150x109/L, Neutrophils > 1.8 x 109/L, Lymphocytes > 1.2x109 cel/mL, .
•–kidney function: creatinine < < 113 µmol/L.
•-Liver function: TGP < 49 U/l y TGO < 46 U/l); ?-glutamiltransferasa (GGT), men = 65 U/l, women = 45 U/l)
•9.Male or female, aged 18-55 years (both inclusive), no preference will be made based on skin color.

•1. Has diagnosis of primary or secondary progressive or progressive relapsing MS
•2.Current use of systemic steroids or immunosuppressive medications within 1 month before randomization
•3.Evidence of significant uncontrolled concomitant disease which in the investigator's opinion would preclude patient participation
•4.History of malignancy.
•5.History of sistemic chronic or acute infection which in the investigator's opinion would preclude patient participation
•6.Patients who have been previously treated with monoclonal antibody.
•7.History of allergy to chemical or biologicl compounds similar to the experimental product.
•8.Pregnancy, childbirth and / or breastfeeding.
•9.Patients who refuse to use contraception during the study.
•10.Patients with intellectual or psychological dysfunction that not allow to understand and compliance with study requirements, according to the Principal Investigator

发起方

Center of Molecular Immunology (CIM)