Natalizumab in Combination With Glatiramer Acetate (GA) in Patients With Relapsing-Remitting Multiple Sclerosis
Phase 2
Completed
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Interventions
- Drug: Placebo
- Registration Number
- NCT00097760
- Lead Sponsor
- Biogen
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 Natalizumab Natalizumab 300 mg, IV infusion, every 4 weeks in addition to 20 mg of glatiramer acetate SC, daily, for up to 20 weeks. Group 2 Placebo Placebo, by IV infusion, every 4 weeks in addition to 20 mg glatiramer acetate, by SC injection, daily, for up to 20 weeks.
- Primary Outcome Measures
Name Time Method Rate of development of new active lesions on MRI scans. Week 20
- Secondary Outcome Measures
Name Time Method Incidence and severity of adverse events. Week 20