PK and PD Study of Natalizumab in Pediatric Subjects With RRMS
PK and PD Study of Natalizumab in Pediatric Subjects With RRMS
The primary objective of the study is to determine the pharmacokinetic (PK) profile of
 multiple doses of natalizumab in pediatric subjects with relapsing-remitting multiple
 sclerosis (RRMS). The secondary objectives are as follows: to characterize the
 pharmacodynamic (PD) profile of natalizumab (as defined by α4 integrin binding) and to
 explore the safety and tolerability of multiple doses of natalizumab in the pediatric
 population.
Key Inclusion Criteria:

 - Rapidly evolving severe relapsing remitting multiple sclerosis, defined by 2 or more
 disabling relapses in 1 year, and with 1 or more gadolinium-enhancing lesions on brain MRI
 or a significant increase in T2 lesion load, as compared to a previous recent magnetic
 resonance imaging (MRI)

 Key Exclusion Criteria:

 -  History of, or abnormal laboratory values indicative of, significant medical,
 neurologic (other than MS), or psychiatric disorders that might preclude participation
 in the study in the opinion of the Investigator.

 -  Prior natalizumab therapy.

 NOTE: Other protocol defined Inclusion/Exclusion criteria may apply