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

December 20, 2016 updated by: Genzyme, a Sanofi Company

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Greenfield Park, Canada, J4V 2J2
        • Investigational Site Number 124001
  • Poland
      • Lodz, Poland, 93-121
        • Investigational Site Number 616001
      • Lublin, Poland, 20-090
        • Investigational Site Number 616004
      • Lublin, Poland, 20-718
        • Investigational Site Number 616003
      • Szczecin, Poland, 70-215
        • Investigational Site Number 616002
  • Russian Federation
      • Kazan, Russian Federation, 420021
        • Investigational Site Number 643010
      • Moscow, Russian Federation, 107150
        • Investigational Site Number 643009
      • Nizhniy Novgorod, Russian Federation, 603155
        • Investigational Site Number 643005
      • Nizhny Novgorod, Russian Federation, 603076
        • Investigational Site Number 643006
      • Novosibirsk, Russian Federation, 630087
        • Investigational Site Number 643008
      • St-Petersburg, Russian Federation, 197089
        • Investigational Site Number 643002
      • St-Petersburg, Russian Federation, 197376
        • Investigational Site Number 643001
  • United States
    • Alabama
      • Cullman, Alabama, United States, 35058
        • Investigational Site Number 840004
    • Colorado
      • Fort Collins, Colorado, United States, 80528
        • Investigational Site Number 840005
    • Florida
      • Ormond Beach, Florida, United States, 32174
        • Investigational Site Number 840007
    • New York
      • Latham, New York, United States, 12210
        • Investigational Site Number 840001
    • Texas
      • Round Rock, Texas, United States, 78681
        • Investigational Site Number 840003
      • San Antonio, Texas, United States, 78258
        • Investigational Site Number 840016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vatelizumab Dose 1
Vatelizumab dose 1 every 4 weeks (Q4W) for 96 weeks
Drug: Vatelizumab

Pharmaceutical form:solution for infusion

Route of administration: intravenous

Other Names:
  • SAR339658
Experimental: Vatelizumab Dose 2
Vatelizumab dose 2 every 4 weeks (Q4W) for 96 weeks
Drug: Vatelizumab

Pharmaceutical form:solution for infusion

Route of administration: intravenous

Other Names:
  • SAR339658
Experimental: Vatelizumab Dose 3
Vatelizumab dose 3 every 4 weeks (Q4W) for 96 weeks
Drug: Vatelizumab

Pharmaceutical form:solution for infusion

Route of administration: intravenous

Other Names:
  • SAR339658
Experimental: Vatelizumab Dose 4
Vatelizumab dose 4 every 4 weeks (Q4W) for 96 weeks
Drug: Vatelizumab

Pharmaceutical form:solution for infusion

Route of administration: intravenous

Other Names:
  • SAR339658

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients experiencing adverse events
Time Frame: from Week 0 to Week 192
from Week 0 to Week 192

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in total volume of T2 lesions
Time Frame: from Week 0 to Week 84
from Week 0 to Week 84
Change in number of T1 hypointense lesions
Time Frame: from Week 0 to Week 84
from Week 0 to Week 84

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genzyme, a Sanofi Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

December 1, 2014

First Submitted That Met QC Criteria

December 1, 2014

First Posted (Estimate)

December 3, 2014

Study Record Updates

Last Update Posted (Estimate)

December 21, 2016

Last Update Submitted That Met QC Criteria

December 20, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LTS13840
  • 2014-003265-19 (EudraCT Number)
  • U1111-1160-6120 (Other Identifier: UTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Relapsing-remitting Multiple Sclerosis

Clinical Trials on Vatelizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe