A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409)
Phase 4
Completed
- Conditions
- MSMultiple sclerosis10012303
- Registration Number
- NL-OMON42054
- Lead Sponsor
- Sanofi-aventis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 3
Inclusion Criteria
- Patient has completed at least 48 months of the Extension Study CAMMS03409
- Signed written informed consent form
Exclusion Criteria
- Patient participating in another investigational interventional study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate long-term safety of alemtuzumab.</p><br>
- Secondary Outcome Measures
Name Time Method <p>* To evaluate long term efficacy of alemtuzumab<br /><br>* To evaluate the safety profile of patients who received other disease<br /><br>modifying therapy following alemtuzumab treatment<br /><br>* To evaluate patient-reported quality of life (QoL) outcomes and health<br /><br>resource utilization of patients who received alemtuzumab<br /><br>* To evaluate as needed re-treatment with alemtuzumab and other disease<br /><br>modifying therapies</p><br>