Clinical trial NCT02306811: Efficacy and Safety of Vatelizumab in Patients Who Completed Treatment in Study DRI13839
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Relapsing-remitting Multiple Sclerosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2014-12-03
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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.

Primary outcomes:
measure: Proportion of patients experiencing adverse events
timeFrame: from Week 0 to Week 192
Secondary outcomes:
measure: Change in total volume of T2 lesions
timeFrame: from Week 0 to Week 84
measure: Change in number of T1 hypointense lesions
timeFrame: from Week 0 to Week 84
Other outcomes:
Locations:
city: Cullman
country: United States
facility: Investigational Site Number 840004
state: Alabama
city: Fort Collins
country: United States
facility: Investigational Site Number 840005
state: Colorado
city: Ormond Beach
country: United States
facility: Investigational Site Number 840007
state: Florida
city: Latham
country: United States
facility: Investigational Site Number 840001
state: New York
city: Round Rock
country: United States
facility: Investigational Site Number 840003
state: Texas
city: San Antonio
country: United States
facility: Investigational Site Number 840016
state: Texas
city: Greenfield Park
country: Canada
facility: Investigational Site Number 124001
city: Lodz
country: Poland
facility: Investigational Site Number 616001
city: Lublin
country: Poland
facility: Investigational Site Number 616004
city: Lublin
country: Poland
facility: Investigational Site Number 616003
city: Szczecin
country: Poland
facility: Investigational Site Number 616002
city: Kazan
country: Russian Federation
facility: Investigational Site Number 643010
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643009
city: Nizhniy Novgorod
country: Russian Federation
facility: Investigational Site Number 643005
city: Nizhny Novgorod
country: Russian Federation
facility: Investigational Site Number 643006
city: Novosibirsk
country: Russian Federation
facility: Investigational Site Number 643008
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643002
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: