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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01051817
First Posted: January 20, 2010
Last Update Posted: February 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
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

Condition Intervention Phase
Relapsing-remitting Multiple Sclerosis RRMS Drug: AIN457 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  • 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.


Enrollment: 73
Study Start Date: December 2009
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AIN457 Drug: AIN457
infusion 10 mg/Kg
Placebo Comparator: Placebo Drug: Placebo
infusion

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01051817


Locations
Czech Republic
Novartis Investigative Site
Hradec Kralove, Czech Republic, 500 05
Novartis Investigative Site
Ostrava-Moravska Ostrava, Czech Republic
Novartis Investigative Site
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
Russian Federation
Novartis Investigative Site
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
Ukraine
Novartis Investigative Site
Kharkiv, Ukraine, 61068
Novartis Investigative Site
Kharkiv, Ukraine
Novartis Investigative Site
Kiev, Ukraine, 03110
Novartis Investigative Site
Kiev, Ukraine
Novartis Investigative Site
Odessa, Ukraine, 65025
Novartis Investigative Site
Vinnitsya, Ukraine, 21005
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01051817     History of Changes
Other Study ID Numbers: CAIN457B2201
2009-011626-34
First Submitted: January 19, 2010
First Posted: January 20, 2010
Results First Submitted: February 12, 2015
Results First Posted: February 27, 2015
Last Update Posted: February 27, 2015
Last Verified: February 2015

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
relapsing-remitting multiple sclerosis
RRMS

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases