NCT00097760

Natalizumab in Combination With Glatiramer Acetate (GA) in Patients With Relapsing-Remitting Multiple Sclerosis

Safety Study of Natalizumab in Combination With Glatiramer Acetate (GA)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if natalizumab in combination with Glatiramer Acetate (GA) is safe and effective in delaying progression of individuals diagnosed with relapsing-remitting Multiple Sclerosis (MS).

Conditions

• Multiple Sclerosis, Relapsing-Remitting

Interventions

Type	Name	Description
DRUG	Natalizumab	Natalizumab 300 mg, IV infusion, every 4 weeks in addition to 20 mg of glatiramer acetate SC, daily, for up to 20 weeks.
DRUG	Natalizumab	Natalizumab, 300 mg IV infusion, every 4 weeks for up to 20 weeks.
DRUG	Placebo	Placebo, by IV infusion, every 4 weeks in addition to 20 mg glatiramer acetate, by SC injection, daily, for up to 20 weeks.

Timeline

• Start date: 2003-06-01
• Primary completion: 2004-03-01
• Completion: 2004-03-01
• First posted: 2004-12-01
• Last updated: 2009-06-18