An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: alemtuzumab
Intervention description: Alemtuzumab 12 mg/day IV infusion on 5 consecutive days if the participants had no prior alemtuzumab exposure (ie, first treatment course). All subsequent treatment courses were for 3 days only.
Intervention MeSH terms: Alemtuzumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 1314.0
Sex: All
Healthy volunteers: No
Keywords: Multiple Sclerosis

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.
    

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).