Multiple Sclerosis
Conditions
Brief summary
The primary objective of this study is to determine the safety and the immunogenicity of extended treatment with natalizumab when administered at a dose of 300 mg intravenously (IV) to subjects with multiple sclerosis (MS) who have completed natalizumab Studies C-1801, C-1802, or C-1803.
Interventions
DRUGNatalizumab
Natalizumab 300 mg by IV infusion, every 4 weeks, for up to 24 months
Sponsors
Biogen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must give written informed consent. * Must be an MS subject who has completed natalizumab Study C-1801, C-1802 or C-1803
Exclusion criteria
* History of, or available abnormal laboratory results, indicative of any significant disease that would preclude treatment. * History of severe allergic or anaphylactic reactions or known drug hypersensitivity * A clinically significant infectious illness within 30 days prior to study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety endpoints under consideration will be the incidence of adverse events, changes in laboratory evaluations, vital signs, and physical examinations. The incidence of development of antibodies to natalizumab will also be assessed. | Month 24 |
Secondary
| Measure | Time frame |
|---|---|
| EDSS scores and assessments of relapse. | Month 24 |
Countries
United States
Outcome results
None listed