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

Phase 2

Completed

• Conditions: Relapsing-remitting Multiple Sclerosis; RRMS
• Interventions: Drug: Placebo; Drug: AIN457

• Registration Number: NCT01051817
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-01-19
• Study First Submitted QC: 2010-01-19
• Study First Posted: 2010-01-20
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2015-02
• Results First Submitted: 2015-02-12
• Results First Submitted QC: 2015-02-12
• Last Update Submitted: 2015-02-12
• Results First Posted: 2015-02-27
• Last Update Posted: 2015-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
AIN457	AIN457	-

Primary Outcome Measures

Name	Time	Method
Summary of Raw Number of Cumulative Combined Unique Active Lesions in Patients With Relapsing Remitting Multiple Sclerosis by Visit and Treatment	weeks 4,8,12,16,20,24,28	Combined unique active lesions (CUAL) observed on brain MRI scans performed every 4th week from week 4 to week 24 in patients with relapsing-remitting multiple sclerosis (RRMS). CUAL is defined as: new gadolinium (Gd)-enhancing lesions on T1-weighted, or new or enlarging lesions on T2-weighted MRI scans, without double counting.

Secondary Outcome Measures

Name	Time	Method
Raw Number of Cumulative New Gd-T1 Lesions	MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS).	The summary of raw number of cumulative new Gadolinium-enhanced T1 lesions observed on brain MRI scans performed every 4th week from WK 4 to WK 28. The end-point is week 24.
Raw Number of Cumulative New Gd-T2 Lesions	MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS).	The summary of raw number of cumulative new Gadolinium-enhanced T2 lesions observed on brain MRI scans performed every 4th week from WK 4 to WK 28. The endpoint is week 24.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇺🇦 Vinnitsya, Ukraine