Status:
TERMINATED
Efficacy and Safety of Vatelizumab in Patients Who Completed Treatment in Study DRI13839
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Relapsing-remitting Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Primary Objective: To assess the long-term safety of vatelizumab in MS patients Secondary Objective: To assess the long-term efficacy of vatelizumab
Detailed Description
The maximum study duration per patient will be 192 weeks, including a Treatment Period of 96 weeks and Post-treatment Safety Follow-up Period of 96 weeks.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients who completed the 12-week treatment period in DRI13839.
- Exclusion criteria:
- Any clinically significant or ongoing adverse events, or laboratory abnormalities from DRI13839 that per Investigator judgment would adversely affect the patient's participation in the long-term extension study.
- Confirmed platelet count below the lower limit of normal at any time during DRI13839.
- Pregnancy or breast-feeding.
- Other protocol defined exclusion criteria may apply.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT02306811
Start Date
February 1 2015
End Date
July 1 2016
Last Update
December 21 2016
Active Locations (18)
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1
Investigational Site Number 840004
Cullman, Alabama, United States, 35058
2
Investigational Site Number 840005
Fort Collins, Colorado, United States, 80528
3
Investigational Site Number 840007
Ormond Beach, Florida, United States, 32174
4
Investigational Site Number 840001
Latham, New York, United States, 12210