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

Relapsing-remitting Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02306811
• Other study ID #: LTS13840
• Secondary ID: 2014-003265-19U1
• Status: Terminated
• Phase: Phase 2
• First received: December 1, 2014
• Last updated: December 20, 2016
• Start date: February 2015
• Est. completion date: July 2016

Study information

• Verified date: December 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

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

Secondary Objective:

To assess the long-term efficacy of vatelizumab

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: July 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Vatelizumab
Pharmaceutical form:solution for infusion Route of administration: intravenous

Locations

Country	Name	City	State
Canada	Investigational Site Number 124001	Greenfield Park
Poland	Investigational Site Number 616001	Lodz
Poland	Investigational Site Number 616003	Lublin
Poland	Investigational Site Number 616004	Lublin
Poland	Investigational Site Number 616002	Szczecin
Russian Federation	Investigational Site Number 643010	Kazan
Russian Federation	Investigational Site Number 643009	Moscow
Russian Federation	Investigational Site Number 643005	Nizhniy Novgorod
Russian Federation	Investigational Site Number 643006	Nizhny Novgorod
Russian Federation	Investigational Site Number 643008	Novosibirsk
Russian Federation	Investigational Site Number 643001	St-Petersburg
Russian Federation	Investigational Site Number 643002	St-Petersburg
United States	Investigational Site Number 840004	Cullman	Alabama
United States	Investigational Site Number 840005	Fort Collins	Colorado
United States	Investigational Site Number 840001	Latham	New York
United States	Investigational Site Number 840007	Ormond Beach	Florida
United States	Investigational Site Number 840003	Round Rock	Texas
United States	Investigational Site Number 840016	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Countries where clinical trial is conducted

United States,  Canada,  Poland,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients experiencing adverse events		from Week 0 to Week 192	Yes
Secondary	Change in total volume of T2 lesions		from Week 0 to Week 84	No
Secondary	Change in number of T1 hypointense lesions		from Week 0 to Week 84	No