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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT01051817

First received: January 19, 2010

Last updated: February 12, 2015

Last verified: February 2015

History of Changes

Tracking Information

First Received Date ^ICMJE

January 19, 2010

Last Updated Date

February 12, 2015

Start Date ^ICMJE

December 2009

Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Summary of Raw Number of Cumulative Combined Unique Active Lesions in Patients With Relapsing Remitting Multiple Sclerosis by Visit and Treatment [ Time Frame: weeks 4,8,12,16,20,24,28 ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

Effect on the number of combined unique active lesions (CUAL) observed on brain MRI scans [ Time Frame: week 4, 8, 12, 16, 20 and 24 ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01051817 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Raw Number of Cumulative New Gd-T1 Lesions [ Time Frame: MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS). ] [ Designated as safety issue: No ]
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 [ Time Frame: MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS). ] [ Designated as safety issue: No ]
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.

Original Secondary Outcome Measures ^ICMJE

Evaluate safety and tolerability [ Time Frame: first dose administration till week 24 ] [ Designated as safety issue: Yes ]
Effect on number of relapses (derived measures as annualized relapse rate/ proportion of relapse-free patients) [ Time Frame: first dose administration till week 24 ] [ Designated as safety issue: No ]
effect on additional MRI parameters observed on brain MRI scans (new/ all T1-weighted lesions, new / enlarging T2-weighted lesions, new MRI disease activity) [ Time Frame: week 4, 8, 12, 16, 20 and 24 ] [ Designated as safety issue: No ]
determine the proportion of subjects without any new disease activity (no new Gd+ or new/ enlarging T2 MRI lesions, no relapses) [ Time Frame: first dose administration till week 24 ] [ Designated as safety issue: No ]
determine steady state plasma concentration in RRMS patients [ Time Frame: first dose administration till week 24 ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Relapsing-remitting Multiple Sclerosis
RRMS

Intervention ^ICMJE

Drug: AIN457
infusion 10 mg/Kg
Drug: Placebo
infusion

Study Arm (s)

Experimental: AIN457
Intervention: Drug: AIN457
Placebo Comparator: Placebo
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2012

Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Exclusion Criteria:

Gender

Both

Ages

18 Years to 55 Years (Adult)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Czech Republic, Russian Federation, Ukraine

Removed Location Countries

Serbia, Sweden

Administrative Information

NCT Number ^ICMJE

NCT01051817

Other Study ID Numbers ^ICMJE

CAIN457B2201, 2009-011626-34

Has Data Monitoring Committee

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Novartis Pharmaceuticals

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

February 2015

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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