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 5 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•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);;or;-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.

•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).

发起方