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NCT02306811

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

NCT ID: NCT02306811

Last Updated: 2016-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-07-31

Brief Summary

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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

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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

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Relapsing-remitting Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vatelizumab Dose 1

Vatelizumab dose 1 every 4 weeks (Q4W) for 96 weeks

Group Type EXPERIMENTAL

Vatelizumab

Intervention Type DRUG

Pharmaceutical form:solution for infusion

Route of administration: intravenous

Vatelizumab Dose 2

Vatelizumab dose 2 every 4 weeks (Q4W) for 96 weeks

Group Type EXPERIMENTAL

Vatelizumab

Intervention Type DRUG

Pharmaceutical form:solution for infusion

Route of administration: intravenous

Vatelizumab Dose 3

Vatelizumab dose 3 every 4 weeks (Q4W) for 96 weeks

Group Type EXPERIMENTAL

Vatelizumab

Intervention Type DRUG

Pharmaceutical form:solution for infusion

Route of administration: intravenous

Vatelizumab Dose 4

Vatelizumab dose 4 every 4 weeks (Q4W) for 96 weeks

Group Type EXPERIMENTAL

Vatelizumab

Intervention Type DRUG

Pharmaceutical form:solution for infusion

Route of administration: intravenous

Interventions

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Vatelizumab

Pharmaceutical form:solution for infusion

Route of administration: intravenous

Intervention Type DRUG

Other Intervention Names

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SAR339658

Eligibility Criteria

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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.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Investigational Site Number 840004

Cullman, Alabama, United States

Site Status

Investigational Site Number 840005

Fort Collins, Colorado, United States

Site Status

Investigational Site Number 840007

Ormond Beach, Florida, United States

Site Status

Investigational Site Number 840001

Latham, New York, United States

Site Status

Investigational Site Number 840003

Round Rock, Texas, United States

Site Status

Investigational Site Number 840016

San Antonio, Texas, United States

Site Status

Investigational Site Number 124001

Greenfield Park, , Canada

Site Status

Investigational Site Number 616001

Lodz, , Poland

Site Status

Investigational Site Number 616004

Lublin, , Poland

Site Status

Investigational Site Number 616003

Lublin, , Poland

Site Status

Investigational Site Number 616002

Szczecin, , Poland

Site Status

Investigational Site Number 643010

Kazan', , Russia

Site Status

Investigational Site Number 643009

Moscow, , Russia

Site Status

Investigational Site Number 643006

Nizhny Novgorod, , Russia

Site Status

Investigational Site Number 643005

Nizhny Novgorod, , Russia

Site Status

Investigational Site Number 643008

Novosibirsk, , Russia

Site Status

Investigational Site Number 643002

Saint Petersburg, , Russia

Site Status

Investigational Site Number 643001

Saint Petersburg, , Russia

Site Status

Countries

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United States Canada Poland Russia

Other Identifiers

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2014-003265-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1160-6120

Identifier Type: OTHER

Identifier Source: secondary_id

LTS13840

Identifier Type: -

Identifier Source: org_study_id