An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab
An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab
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:
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.
Inclusion Criteria:
Exclusion Criteria:
Phoenix, Arizona, United States
Berkeley, California, United States
Los Angeles, California, United States
Washington D.C., District of Columbia, United States
Des Moines, Iowa, United States
Detroit, Michigan, United States
Grand Rapids, Michigan, United States
New York, New York, United States
Winston-Salem, North Carolina, United States
Providence, Rhode Island, United States
Auchenflower QLD, Australia
Århus C, Denmark
Wermsdorf, Germany
Sittard-Geleen, Netherlands
Poznan, Poland
Novosibirsk, Russia
Pyatigorsk, Russia
Saint Petersburg, Russia
Kharkiv, Ukraine
Kiev, Ukraine
Kiev-21, Ukraine