Subcutaneous and Intramuscular Natalizumab in Subjects with Multiple Sclerosis (MS)

Trial Status
Open for Enrollment

What is the Purpose of this Study?
To compare the PK and pharmacodynamics of a range of single subcutaneious (SC) and intramuscular injection (IM) doses of natalizumab to IV administration of 300 mg natalizumab in MS subjects.

Who is Eligible to Participate?
Patients aged 18-65 with SPMS without superimposed relapses, and who are willing to remain free from concomitant immunosuppressive or immunomodulatory treatment for the duration of the study and who do not meet any exclusionary criteria which will be addressed in further detail by the study coordinator.

What is involved in this Study?
This is an open label, dose ranged study. The ratio will be 1:1:1 to receive a single dose of SC, IM, or IV 300mg. The study will evaluate 5 treatment groups. Group 1: 300 mg IV, Group 2: 300 mg IM, Group 3: 300 mg SC, Group 4: 200 mg SC and Group 5: dose and route will be determined after review of preliminary PK and PD data from the 300 mg treatment groups.

How long is the Study?
The study is approximately 40 weeks, with 28 weeks of treatment.

For More Information Contact: Lynne E. Flynn, CCRC, study coordinator, at 602-258-2863 or lynneflynn@pnal.net or call the Main line at 602-258-3354