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

• Register: ClinicalTrials.gov
• Last refreshed on: 9 January 2017
• Main ID: NCT02306811
• Date of registration: 01/12/2014
• Prospective Registration: Yes
• Primary sponsor: Genzyme, a Sanofi Company
• Public title: Efficacy and Safety of Vatelizumab in Patients Who Completed Treatment in Study DRI13839
• Scientific title: A Long-Term Follow-up Study Assessing the Safety and Efficacy of Vatelizumab in Multiple Sclerosis (MS) Patients Who Completed Treatment in Study DRI13839
• Date of first enrolment: February 2015
• Target sample size: 62
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02306811
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Canada, Poland, Russian Federation, United States

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Relapsing-remitting Multiple Sclerosis

Intervention(s)

Drug: Vatelizumab

Primary Outcome(s)

Proportion of patients experiencing adverse events [Time Frame: from Week 0 to Week 192]

Secondary Outcome(s)

Change in total volume of T2 lesions [Time Frame: from Week 0 to Week 84]

Change in number of T1 hypointense lesions [Time Frame: from Week 0 to Week 84]

Secondary ID(s)

2014-003265-19

U1111-1160-6120

LTS13840

Source(s) of Monetary Support

Please refer to primary and secondary sponsors