NCT01058005

Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis

A Multicenter, Randomized, Open-Label, Parallel-Group, Active-Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon Beta-1a) to Natalizumab in Subjects With Relapsing Remitting Multiple Sclerosis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This was a multicenter, randomized, open-label, parallel-group, active-controlled study. Prior to randomization, participants were to have been treated with glatiramer acetate or interferon β-1a (44 μg). Participants were to be randomized to receive natalizumab, interferon β-1a 44 μg, or glatiramer acetate.

Detailed description

The protocol was amended in 15 March 2011 to discontinue participants' enrollment and efficacy assessments, and to offer the opportunity for participants already enrolled to continue receiving study treatment for their planned participation in the study. The study had been active in several countries for approximately 1 year, and enrollment had been significantly slower than expected. Thus, the decision was made by the Sponsor to terminate the study since current and projected future enrollment rates would not have provided valuable information in a reasonable timeframe. All clinical efficacy and magnetic resonance imaging (MRI) procedures were removed from the protocol, and safety assessments were to be managed through standard of care activities.

Conditions

• Relapsing Remitting Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	BG00002 (natalizumab)	300 mg intravenous injection every 4 weeks
DRUG	interferon beta-1a	44 mcg subcutaneous injection 3 times per week
DRUG	glatiramer acetate	20 mg subcutaneous injection once daily

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2010-01-28
• Last updated: 2014-09-03
• Results posted: 2014-08-13

Locations

42 sites across 13 countries: United States, Australia, Canada, Czechia, Finland, France, Hungary, Italy, Latvia, Poland, Slovenia, Spain, Sweden