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About
This was a randomized, partially blinded, placebo-controlled, non-confirmatory study to assess the effects of a single infusion of VAY736 on disease activity as measured by brain MRI scans in patients with relapsing-remitting multiple sclerosis (RRMS).
Full description
The study was planned to be conducted in approximately 96 patients. However, after enrolling 8 patients, the recruitment was terminated based on strategic considerations.
Enrollment
Sex
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Inclusion and exclusion criteria
Key inclusion criteria:
Male and female patients aged 18 to 55 years.
Diagnosis of MS as defined by the 2010 revised McDonald criteria (Polman et al 2011).
A relapsing-remitting course of disease with:
An Expanded Disability Status Scale (EDSS) score of 0-5.0 inclusive at screening.
No evidence of a relapse within 30 days prior to randomization.
Key exclusion criteria:
Primary purpose
Allocation
Interventional model
Masking
8 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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