Study:
An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab
Rationale:
n/a
Purpose:
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.
Study Status: Active, not recruiting
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Multiple Sclerosis, Relapsing-Remitting |
Biological: alemtuzumab
Biological: alemtuzumab |
Phase 3 |
Verified by
Genzyme
February, 2013
Sponsored by: Genzyme
Information provided by: Genzyme
ClinicalTrials.gov identifier: NCT00930553
Study Type: Interventional
Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Cleveland Clinic Foundation
Cleveland, Ohio
United States
Medical Monitor., Study Director