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

Primary Purpose

Relapsing-remitting Multiple Sclerosis, RRMS

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AIN457
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing-remitting Multiple Sclerosis focused on measuring relapsing-remitting multiple sclerosis, RRMS

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-

Exclusion Criteria:

-

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AIN457

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Summary of Raw Number of Cumulative Combined Unique Active Lesions in Patients With Relapsing Remitting Multiple Sclerosis by Visit and Treatment
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

Raw Number of Cumulative New Gd-T1 Lesions
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
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.

Full Information

First Posted
January 19, 2010
Last Updated
February 12, 2015
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01051817
Brief Title
POC-MD MRI-based Trial in Relapsing-remitting Multiple Scler
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing-remitting Multiple Sclerosis, RRMS
Keywords
relapsing-remitting multiple sclerosis, RRMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AIN457
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AIN457
Intervention Description
infusion 10 mg/Kg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
infusion
Primary Outcome Measure Information:
Title
Summary of Raw Number of Cumulative Combined Unique Active Lesions in Patients With Relapsing Remitting Multiple Sclerosis by Visit and Treatment
Description
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.
Time Frame
weeks 4,8,12,16,20,24,28
Secondary Outcome Measure Information:
Title
Raw Number of Cumulative New Gd-T1 Lesions
Description
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.
Time Frame
MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS).
Title
Raw Number of Cumulative New Gd-T2 Lesions
Description
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.
Time Frame
MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Ostrava-Moravska Ostrava
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Ostrava
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Praha 10
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Praha 2
ZIP/Postal Code
128 08
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Teplice
ZIP/Postal Code
415 29
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Kazan
ZIP/Postal Code
420021
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
129128
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Nizhny Novgorod
ZIP/Postal Code
603155
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Novartis Investigative Site
City
Kharkiv
Country
Ukraine
Facility Name
Novartis Investigative Site
City
Kiev
ZIP/Postal Code
03110
Country
Ukraine
Facility Name
Novartis Investigative Site
City
Kiev
Country
Ukraine
Facility Name
Novartis Investigative Site
City
Odessa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Novartis Investigative Site
City
Vinnitsya
ZIP/Postal Code
21005
Country
Ukraine

12. IPD Sharing Statement

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

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