NCT01071083

Treatment Interruption of Natalizumab

Randomized Treatment Interruption of Natalizumab

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, rater blinded trial in patients who interrupt treatment with natalizumab with or without being treated with other immunomodulatory drugs, or continue treatment with natalizumab. The main purpose of this study is to find out the following, when participants stop taking natalizumab for 24 weeks: * when MS symptoms return, and * if other drugs for MS may help control MS symptoms during the natalizumab-interruption period. This study will also explore how quickly the effects of natalizumab return after resuming natalizumab dosing.

Conditions

• Relapsing Remitting Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	natalizumab	300 mg intravenous every 4 weeks
DRUG	interferon beta 1-a	30 ug intramuscular once per week
DRUG	methylprednisolone	1000 mg intravenous every 4 weeks
OTHER	IV placebo	placebo intravenous every 4 weeks
DRUG	glatiramer acetate	20 mg subcutaneous once daily

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2010-02-19
• Last updated: 2013-09-19
• Results posted: 2013-01-30

Locations

33 sites across 3 countries: United States, Germany, Spain