NCT01416155

Extension Study to Evaluate Safety and Efficacy of Natalizumab in Japanese Participants With Relapsing-Remitting Multiple Sclerosis

A Long-Term, Open-Label, Multicenter, Extension Study to Evaluate Safety and Efficacy of BG00002 in Japanese Subjects With Relapsing-Remitting Multiple Sclerosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to further evaluate the long-term safety and tolerability profiles of BG00002 (natalizumab) in Japanese participants with relapsing-remitting multiple sclerosis (RRMS). The secondary objective of this study is to further evaluate the long-term efficacy profile of BG00002 in Japanese participants with RRMS.

Detailed description

This is a multicenter, long-term, open-label, extension study in participants who have successfully completed Study 101MS203 (NCT01440101).

Conditions

• Relapsing-Remitting Multiple Sclerosis
• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	natalizumab

Timeline

• Start date: 2010-10-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2011-08-12
• Last updated: 2016-01-14
• Results posted: 2016-01-14

Locations

22 sites across 1 country: Japan