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NCT01051817 Clinical Trial

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

Relapsing-remitting Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01051817
Other study ID # CAIN457B2201
Secondary ID 2009-011626-34
Status Completed
Phase Phase 2
First received January 19, 2010
Last updated February 12, 2015
Start date December 2009
Est. completion date April 2012

Study information
Verified date February 2015
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 73
Est. completion date April 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• AIN457
infusion 10 mg/Kg
• Placebo
infusion

Locations
Country Name City State
Czech Republic Novartis Investigative Site Hradec Kralove
Czech Republic 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 Novartis Investigative Site Teplice
Russian Federation Novartis Investigative Site Kazan
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Nizhny Novgorod
Russian Federation Novartis Investigative Site Smolensk
Ukraine Novartis Investigative Site Kharkiv
Ukraine Novartis Investigative Site Kharkiv
Ukraine Novartis Investigative Site Kiev
Ukraine Novartis Investigative Site Kiev
Ukraine Novartis Investigative Site Odessa
Ukraine Novartis Investigative Site Vinnitsya

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Czech Republic,  Russian Federation,  Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. weeks 4,8,12,16,20,24,28 No
Secondary 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. MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS). No
Secondary 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. MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS). No
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