NCT02306811

Efficacy and Safety of Vatelizumab in Patients Who Completed Treatment in Study DRI13839

A Long-Term Follow-up Study Assessing the Safety and Efficacy of Vatelizumab in Multiple Sclerosis (MS) Patients Who Completed Treatment in Study DRI13839

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsing-remitting Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Vatelizumab	Pharmaceutical form:solution for infusion Route of administration: intravenous

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-04-01
• Completion: 2016-07-01
• First posted: 2014-12-03
• Last updated: 2016-12-21

Locations

18 sites across 4 countries: United States, Canada, Poland, Russia