An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study

Genzyme Corporation0 个研究点目标入组 1,500 人开始时间: 2009年10月5日最近更新: 2016年5月2日

适应症

试验速览

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•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:
•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

•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 psychosis
•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).

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