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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

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 ] [ 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.


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). ] [ 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.


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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-

Exclusion Criteria:

-

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01051817

Locations
Czech Republic
Novartis Investigative Site
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
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
Novartis Investigative Site
Kiev, Ukraine, 03110
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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01051817     History of Changes
Other Study ID Numbers: CAIN457B2201, 2009-011626-34
Study First Received: January 19, 2010
Results First Received: February 12, 2015
Last Updated: February 12, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
relapsing-remitting multiple sclerosis
RRMS

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

ClinicalTrials.gov processed this record on May 05, 2015