An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab

This open-label, rater-blinded extension study will enroll patients who have 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 are: 1. To examine the long term safety and efficacy of alemtuzumab treatment in patients 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 patients who received Rebif® (interferon beta-1a) as their study treatment in one of the prior studies. 3. To determine if and when further alemtuzumab treatment is needed, and the safety and efficacy of this "as needed" treatment. This applies both to patients who received alemtuzumab for the first time in one of the prior studies or for the first time in this extension study.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • biological : alemtuzumab
  • biological : alemtuzumab

Phase: Phase 3

Eligibility

Ages Eligible For Study:

N/A - N/A

Inclusion Criteria

- 1.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 - 2.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 - 3.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.

External Links

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Contact information

Primary Contact:

Jeffrey Dunn, MD 650-736-4310

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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