EUCTR2009-010788-18-IT进行中（未招募）1 期
An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - ND
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Received alemtuzumab in CAMMS323 or CAMMS324, completed the 2-year study period, and have NOT subsequently received DMTs (other than glatiramer acetate or interferon beta) 2. Received SC IFNB-1a in CAMMS323 or CAMMS324, completed the 2-year study period, and have NOT subsequently received alternative DMTs (other than glatiramer acetate or another interferon beta) 3. Participated in CAMMS223
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Alemtuzumab treated patients: 1)Any patient who has received alemtuzumab off-label (ie, outside of one of the prior Genzyme studies) will be excluded from participating in this study. 2)Ongoing participation in any other investigational study, unless approved by Genzyme. Iin addition, alemtuzumab patients must be screened for disqualifying safety concerns (ref. prot. Sect. 9.2.3) before receiving retreatment. SC IFNB-1a treated patients: 1)Does not wish to receive alemtuzumab 2)Ongoing participation in any other investigational study 3)Has received alemtuzumab off-label (ie, outside of one of the prior Genzyme studies) 4)Known bleeding disorder (eg,dysfibrinogenemia,factor IX deficiency,hemophilia,Von Willebrand`s disease,Disseminated Intravascular Coagulation,fibrinogen deficiency,or other clotting factor deficiency) or therapeutic anticoagulation 5)Diagnosis of ITP,or other autoimmune hematologic abnormality.Patients who were diagnosed with ITP per the protocol definition in one of the prior studies can still be considered for the extension study if the ITP was not considered to be autoimmune. Such situations require prior approval by Genzyme 6)History of malignancy, except basal cell skin carcinoma 7)Intolerance of pulsed corticosteroids, especially a history of steroid psychosis 8)Significant autoimmune disease including but not limited to: immune cytopenias,rheumatoid arthritis,systemic lupus erythematosus,other connective tissue disorders,vasculitis,inflammatory bowel disease,severe psoriasis, or anti-GBM disease (also known as Goodpasture s disease) 9)Major psychiatric disorder or epileptic seizures not adequately controlled by treatment 10)Infection with hepatitis B or C virus, seropositivity for HIV 11)History of invasive fungal infections 12)Unwilling to agree to use a reliable and acceptable contraceptive method throughout the study period (fertile patients only). Reliable and effective contraceptive method(s) include: intrauterine device (IUD),hormonal-based contraception,surgical sterilization,abstinence or double-barrier contraception (condom and occlusive cap [diaphragm or cervical cap with spermicide])
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