an extension protocol for multiple sclerosis patients who participated in genzyme-sponsored studies of alemtuzumab

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: this open-label, rater-blinded extension study enrolled participants who had relapsing-remitting multiple sclerosis (rrms) and who participated in one of three prior genzyme-sponsored studies of alemtuzumab (camms223 \[nct00050778\], camms323 \[nct00530348\] also known as care-ms i, or camms324 \[nct00548405\] also known as care-ms ii). the purposes of this study were: 1. to examine the long term safety and efficacy of alemtuzumab treatment in participants who received alemtuzumab as their study treatment in one of the prior studies. 2. to examine the safety and efficacy of initial alemtuzumab treatment in this study for participants who received rebif® (interferon beta-1a) as their study treatment in one of the prior studies. 3. to determine the safety and efficacy of additional "as needed" alemtuzumab treatment courses. this applied both to participants who received alemtuzumab for the first time in one of the prior studies or for the first time in this extension study.

alemtuzumab treatment was on a fixed schedule of two treatment courses a year apart for participants who received rebif® in one of the prior genzyme-sponsored studies of alemtuzumab or on an as needed schedule (e.g. due to documented evidence of resumed multiple sclerosis \[ms\] activity) for participants who had already completed a fixed schedule of treatment with alemtuzumab in one of the prior genzyme-sponsored studies. there was no comparison treatment in this study. all participants were required to return to their study site every 3 months for neurologic and other assessments. in addition, safety-related laboratory tests and surveys were performed at least monthly. participation in the extension study was at least 48 months from enrollment. study duration could be extended to allow participants to remain in the study until a follow-up study was available in their country or through month 60 (month 72 in usa), whichever occurred first.

Eligibility criteria:
inclusion criteria: * 1.received alemtuzumab in camms323 or camms324, completed the 2-year study period, and had not subsequently received disease modifying treatments (other than glatiramer acetate or interferon beta); or * 2.received rebif® in camms323 or camms324, completed the 2-year study period, and had not subsequently received alternative disease modifying treatments (other than glatiramer acetate or another interferon beta); or * 3.participated in camms223. * note: criteria 1 and 2 above meant that participants 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 were not eligible for inclusion in the extension study. participants who enrolled in camms324 after participation in camms223 must meet criteria 1 or 2 to be eligible for inclusion in the extension study. exclusion criteria: * any alemtuzumab participant from camms223, camms323, or camms324 who had received alemtuzumab off-label (ie, outside of one of the prior genzyme-sponsored studies), or was participating in any other investigational study, unless approved by genzyme. in addition, these participants must be screened for disqualifying safety concerns before receiving alemtuzumab retreatment. * any rebif® participants from camms223, camms323, or camms324 who met any of the following criteria. in addition, these participants must be screened for disqualifying safety concerns before receiving alemtuzumab treatment. a) did not wish to receive alemtuzumab; b) ongoing participation in any other investigational study, unless approved by genzyme; c) had 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 participants only).

Keywords: multiple sclerosis