Primary Objective: To assess the long-term safety of vatelizumab in MS patients Secondary Objective: To assess the long-term efficacy of vatelizumab
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
62
Pharmaceutical form:solution for infusion Route of administration: intravenous
Investigational Site Number 840004
Cullman, Alabama, United States
Investigational Site Number 840005
Fort Collins, Colorado, United States
Proportion of patients experiencing adverse events
Time frame: from Week 0 to Week 192
Change in total volume of T2 lesions
Time frame: from Week 0 to Week 84
Change in number of T1 hypointense lesions
Time frame: from Week 0 to Week 84
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Investigational Site Number 840007
Ormond Beach, Florida, United States
Investigational Site Number 840001
Latham, New York, United States
Investigational Site Number 840003
Round Rock, Texas, United States
Investigational Site Number 840016
San Antonio, Texas, United States
Investigational Site Number 124001
Greenfield Park, Canada
Investigational Site Number 616001
Lodz, Poland
Investigational Site Number 616004
Lublin, Poland
Investigational Site Number 616003
Lublin, Poland
...and 8 more locations