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

February 12, 2015 updated by: Novartis Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Hradec Kralove, Czech Republic, 500 05
        • Novartis Investigative Site
      • Ostrava, Czech Republic
        • Novartis Investigative Site
      • Ostrava-Moravska Ostrava, Czech Republic
        • Novartis Investigative Site
      • Praha 10, Czech Republic
        • Novartis Investigative Site
      • Praha 2, Czech Republic, 128 08
        • Novartis Investigative Site
      • Teplice, Czech Republic, 415 29
        • Novartis Investigative Site
  • Russian Federation
      • Kazan, Russian Federation, 420021
        • Novartis Investigative Site
      • Moscow, Russian Federation, 129128
        • Novartis Investigative Site
      • Nizhny Novgorod, Russian Federation, 603155
        • Novartis Investigative Site
      • Smolensk, Russian Federation, 214019
        • Novartis Investigative Site
  • Ukraine
      • Kharkiv, Ukraine, 61068
        • Novartis Investigative Site
      • Kharkiv, Ukraine
        • Novartis Investigative Site
      • Kiev, Ukraine
        • Novartis Investigative Site
      • Kiev, Ukraine, 03110
        • Novartis Investigative Site
      • Odessa, Ukraine, 65025
        • Novartis Investigative Site
      • Vinnitsya, Ukraine, 21005
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

-

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
infusion
Experimental: AIN457
Drug: AIN457
infusion 10 mg/Kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
weeks 4,8,12,16,20,24,28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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.
MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS).
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).
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.
MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

January 19, 2010

First Submitted That Met QC Criteria

January 19, 2010

First Posted (Estimate)

January 20, 2010

Study Record Updates

Last Update Posted (Estimate)

February 27, 2015

Last Update Submitted That Met QC Criteria

February 12, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAIN457B2201
  • 2009-011626-34

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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