NCT01405820

Exploratory Study of the Safety, Tolerability and Efficacy of Multiple Regimens of Natalizumab in Adult Participants With Relapsing Multiple Sclerosis (MS)

A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 290 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to explore the effects of multiple regimens of natalizumab on disease activity and safety in participants with relapsing-remitting Multiple Sclerosis (RRMS).

Detailed description

This is a a dose and frequency (but not route of administration) blinded, prospective, randomized, dose-ranging study in patients with RRMS who have received natalizumab for at least 12 months according to the local prescribing guidelines. The study will explore dosing of natalizumab by subcutaneous and intravenous routes. Participants will be randomly assigned to 1 of 6 dosing regimens, blinded to natalizumab dose, but not route, for 60 weeks of treatment.

Conditions

• Relapsing-Remitting Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	natalizumab IV	natalizumab for IV Infusion
DRUG	natalizumab SC	natalizumab for Subcutaneous Injection
DRUG	IV Placebo	Intravenous placebo to natalizumab
DRUG	SC Placebo	Subcutaneous placebo to natalizumab

Timeline

• Start date: 2011-08-01
• Primary completion: 2014-04-01
• Completion: 2014-10-01
• First posted: 2011-07-29
• Last updated: 2015-08-21
• Results posted: 2015-07-29

Locations

64 sites across 5 countries: Belgium, France, Germany, Italy, Spain