None listed
Conditions
Interventions
All study subjects will receive up to 13 IV infusions (1 every 4 weeks) of natalizumab
Sponsors
Biogen Idec
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
Must be an MS subject who completed Study C-1801 or C-1802 and completed a Dosing Suspension Safety Evaluation (neurological examination and an MRI scan); must be considered by the Investigator to be free of signs and symptoms suggestive of PML based on medical history, physical examination, or laboratory testing (results from the Dosing Suspension Safety Evaluation from Study C-1808 may be used); must be willing to discontinue and remain free from concomitant immunosuppressive or immunomodulatory treatment (including IFNb and GA) for the duration of the study.
Exclusion criteria
Considered by the Investigator to be immunocompromised or have a history of organ transplant; history of persistent anti-natalizumab antibodies, based upon testing from prior natalizumab studies; history of severe allergic or anaphylactic reactions or known drug hypersensitivity; discontinued natalizumab in a previous study due to allergic reaction or any other SAE considered to be related to natalizumab treatment; discontinued study drug in Study C-1801 or C-1802 because of an AE or due to reasons other than significant disease progression (as defined in the C-1801 and C-1802 protocols).
Outcome results
None listed