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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02306811
Recruitment Status : Terminated (Study discontinued based on planned interim analysis of the primary endpoint. Not linked to any safety concern.)
First Posted : December 3, 2014
Last Update Posted : December 21, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Description
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Brief Summary:

Primary Objective:

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

Secondary Objective:

To assess the long-term efficacy of vatelizumab


Condition or disease Intervention/treatment Phase
Relapsing-remitting Multiple Sclerosis Drug: Vatelizumab Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : February 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: 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 Name: 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 Name: SAR339658


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients experiencing adverse events [ Time Frame: from Week 0 to Week 192 ]

Secondary Outcome Measures :
  1. Change in total volume of T2 lesions [ Time Frame: from Week 0 to Week 84 ]
  2. Change in number of T1 hypointense lesions [ Time Frame: from Week 0 to Week 84 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02306811


Locations
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Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
More Information
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Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT02306811    
Other Study ID Numbers: LTS13840
2014-003265-19 ( EudraCT Number )
U1111-1160-6120 ( Other Identifier: UTN )
First Posted: December 3, 2014    Key Record Dates
Last Update Posted: December 21, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
 Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases