Efficacy and Safety of Vatelizumab in Patients Who Completed Treatment in Study DRI13839
| Status: | Terminated |
|---|---|
| Conditions: | Neurology, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/22/2016 |
| Start Date: | February 2015 |
| End Date: | July 2016 |
A Long-Term Follow-up Study Assessing the Safety and Efficacy of Vatelizumab in Multiple Sclerosis (MS) Patients Who Completed Treatment in Study DRI13839
Primary Objective:
To assess the long-term safety of vatelizumab in MS patients
Secondary Objective:
To assess the long-term efficacy of vatelizumab
To assess the long-term safety of vatelizumab in MS patients
Secondary Objective:
To assess the long-term efficacy of vatelizumab
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.
weeks and Post-treatment Safety Follow-up Period of 96 weeks.
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.
We found this trial at
7
sites
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