Multiple Sclerosis, Relapsing-Remitting
Conditions
Keywords
Multiple Sclerosis, MS
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).
Interventions
DRUGNatalizumab
Natalizumab 300 mg, IV infusion, every 4 weeks in addition to 20 mg of glatiramer acetate SC, daily, for up to 20 weeks.
DRUGPlacebo
Placebo, by IV infusion, every 4 weeks in addition to 20 mg glatiramer acetate, by SC injection, daily, for up to 20 weeks.
Sponsors
Elan Pharmaceuticals
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of development of new active lesions on MRI scans. | Week 20 |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events. | Week 20 |
Outcome results
None listed