A Study to Evaluate the Safety and Efficacy of Rituximab in Adults With Primary Progressive Multiple Sclerosis

Sponsor
Genentech, Inc.
Study ID
NCT00087529
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • placebo — DRUG
    Intravenous repeating dose
  • rituximab — DRUG
    Intravenous repeating dose

Study Details

This is a Phase II/III, randomized, double-blind, parallel group, placebo controlled, multicenter study to evaluate the safety and efficacy of rituximab in adults with PPMS. The study will enroll approximately 435 subjects at up to 60 sites in the United States and Canada.

Key Dates

Start date
Jun 30, 2004
Status verified
Aug 2015
Primary completion
Oct 31, 2007

Study Design

Enrollment
439 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
  • Placebo Comparator: 2

Primary Outcome Measure

Time to Confirmed Disease Progression (CDP) [ Time Frame: 96 weeks (from Screening to Week 96, and at least 12 weeks after initial progression) ]

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