NCT00097760CompletedPhase 2
Safety Study of Natalizumab in Combination With Glatiramer Acetate (GA)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Biogen
- Enrollment
- 110
- Primary Endpoint
- Rate of development of new active lesions on MRI scans.
Study Overview
Brief Summary
The purpose of this study is to determine if natalizumab in combination with Glatiramer Acetate (GA) is safe and effective in delaying progression of individuals diagnosed with relapsing-remitting Multiple Sclerosis (MS).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of MS as defined by McDonald et al., criteria # 1-4
- •Between the ages of 18 and 55, inclusive
- •Baseline EDSS score between 0.0 and 5.0, inclusive
- •Have been treated with GA for at least the 12 months prior to randomization
Exclusion Criteria
- •Primary progressive, secondary progressive or progressive relapsing MS
- •MS relapse has occurred within the 50 days prior to randomization
- •A clinically significant infectious illness
- •History of, or abnormal lab result indicative of significant disease that would preclude the administration of a recombinant humanized antibody immunomodulating agent or GA for 20 weeks.
Arms & Interventions
Group 2
Placebo Comparator
Placebo, by IV infusion, every 4 weeks in addition to 20 mg glatiramer acetate, by SC injection, daily, for up to 20 weeks.
Intervention: Placebo (Drug)
Group 1
Experimental
Natalizumab 300 mg, IV infusion, every 4 weeks in addition to 20 mg of glatiramer acetate SC, daily, for up to 20 weeks.
Intervention: Natalizumab (Drug)
Outcomes
Primary Outcomes
Rate of development of new active lesions on MRI scans.
Time Frame: Week 20
Secondary Outcomes
- Incidence and severity of adverse events.(Week 20)
Investigators
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