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01
Overview
Phase 2, randomised, double-blind trial in relapsing-remitting multiple sclerosis (RRMS) comparing Rituximab with Placebo (2 arms). Primary endpoints: Total number of gadolinium-enhancing lesions observed on brain MRI scans at 24 weeks and Safety and tolerability of rituximab at 48 weeks. Started Dec 2004; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Rituximab
Rituximab 1000 mg IV on Days 1 and 15
Placebo
Placebo IV on Days 1 and 15
03
Who it enrols
Adults 18-55 with Relapsing Remitting MS, EDSS 0-5.0, and at least one relapse in the prior year. Excludes PPMS, SPMS, prior Rituximab, and recent use of other MS therapies.
04
Endpoints
Primary
Total number of gadolinium-enhancing lesions observed on brain MRI scans
Safety and tolerability of rituximab
Secondary
Efficacy of rituximab compared with placebo
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