Trial Search Results
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:
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.
Stanford is currently not accepting patients for this trial.
Genzyme, a Sanofi Company
- Biological: alemtuzumab
- 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.
- 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).
Ages Eligible for Study
N/A - N/A
Genders Eligible for Study