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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

January 19, 2010
February 12, 2015
December 2009
April 2012   (final data collection date for primary outcome measure)
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.
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 ]
Complete list of historical versions of study NCT01051817 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 ]
Not Provided
Not Provided
 
POC-MD MRI-based Trial in Relapsing-remitting Multiple Scler
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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Relapsing-remitting Multiple Sclerosis
  • RRMS
  • Drug: AIN457
    infusion 10 mg/Kg
  • Drug: Placebo
    infusion
  • Experimental: AIN457
    Intervention: Drug: AIN457
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
73
April 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

-

Exclusion Criteria:

-

Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Russian Federation,   Ukraine
 
NCT01051817
CAIN457B2201, 2009-011626-34
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
February 2015

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