NCT01051817

POC-MD MRI-based Trial in Relapsing-remitting Multiple Scler

A Randomized, Multi-center, Double-blind, Proof-of-concept Study to Assess the Effect of Multiple Infusion of AIN457 (10 mg/kg) Versus Placebo on Disease Activity as Measured by MRI Scans Over a 24 Week Period in Patients With Relapsing-remitting Multiple Sclerosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

A randomized, multi-center, double-blind, proof-of-concept study to assess the effect of multiple infusions of AIN457 (10 mg/kg) versus placebo on disease activity as measured by MRI scans over a 24 week period in patients with relapsing-remitting multiple sclerosis

Conditions

• Relapsing-remitting Multiple Sclerosis
• RRMS

Interventions

Type	Name	Description
DRUG	AIN457	infusion 10 mg/Kg
DRUG	Placebo	infusion

Timeline

• Start date: 2009-12-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2010-01-20
• Last updated: 2015-02-27
• Results posted: 2015-02-27

Locations

16 sites across 3 countries: Czechia, Russia, Ukraine