EUCTR2009-010788-18-GB进行中（未招募）1 期
An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,314
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
入选标准
- •Patients must meet ONE of the following criteria to participate in the
- •Extension Study:
- •-Received alemtuzumab in CAMMS323 or CAMMS324, completed the 2-
- •year study period, and have not subsequently received disease
- •modifying treatments (other than glatiramer acetate or interferon beta);
- •-Received Rebif® in CAMMS323 or CAMMS324, completed the 2-year
- •study period, and have not subsequently received alternative disease
- •modifying treatments (other than glatiramer acetate or another
- •interferon beta); or
- •-Participated in CAMMS223.
- •NOTE: Criteria 1 and 2 above mean that patients who enrolled in
- •CAMMS323 or CAMMS324 but did not complete the 2-year study period
- •or went on to receive non-study drug DMTs after randomization are not eligible for inclusion in the Extension Study. Patients who enrolled in
- •CAMMS324 after participation in CAMMS223 must meet criteria 1 or 2 to be eligible for inclusion in the Extension Study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1500
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Any alemtuzumab patient from CAMMS223, CAMMS323, or CAMMS324
- •who has received alemtuzumab off-label (ie, outside of one of the prior
- •Genzyme-sponsored studies) or is participating in any other
- •investigational study, unless approved by Genzyme. In addition, these
- •patients must be screened for disqualifying safety concerns before
- •receiving alemtuzumab retreatment.
- •Any Rebif® patient from CAMMS223, CAMMS323, or CAMMS324 who
- •meets any of the following criteria. In addition, these patients must be
- •screened for disqualifying safety concerns before receiving alemtuzumab treatment.
- •a)Does not wish to receive alemtuzumab;
- •b) Ongoing participation in any other investigational study , unless
- •approved by Genzyme;
- •c)Has received alemtuzumab off-label (ie, outside of one of the prior
- •Genzyme-sponsored studies);
- •d)Known bleeding disorder or therapeutic anticoagulation;
- •e)Diagnosis of idiopathic thrombocytopenia purpura or other
- •autoimmune hematologic abnormality;
- •f)History of malignancy, except basal cell skin carcinoma;
- •g)Intolerance of pulsed corticosteroids, especially a history of steroid
- •h)Significant Autoimmune disorder (other than MS);
- •i)Major psychiatric disorder or epileptic seizures not adequately
- •controlled by treatment;
- •j)Active infection or high risk for infection
- •k)Unwilling to use a reliable and acceptable contraceptive method during
- •and for at least 6 months following each alemtuzumab treatment cycle
- •(fertile patients only).
研究者
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