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

• Status: Terminated
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

To assess the long-term safety of vatelizumab in MS patients

Secondary Objective:

To assess the long-term efficacy of vatelizumab

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genzyme, a Sanofi Company

Criteria

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.