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

Tracking Information
First Submitted Date ICMJE	January 19, 2010
First Posted Date ICMJE	January 20, 2010
Results First Submitted Date	February 12, 2015
Results First Posted Date	February 27, 2015
Last Update Posted Date	February 27, 2015
Study Start Date ICMJE	December 2009
Actual Primary Completion Date	April 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: February 12, 2015)	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.
Original Primary Outcome Measures ICMJE; (submitted: January 19, 2010)	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 ]
Change History	Complete list of historical versions of study NCT01051817 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: February 12, 2015)	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.
Original Secondary Outcome Measures ICMJE; (submitted: January 19, 2010)	Evaluate safety and tolerability [ Time Frame: first dose administration till week 24 ]; Effect on number of relapses (derived measures as annualized relapse rate/ proportion of relapse-free patients) [ Time Frame: first dose administration till week 24 ]; 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 ]; 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 ]; determine steady state plasma concentration in RRMS patients [ Time Frame: first dose administration till week 24 ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	POC-MD MRI-based Trial in Relapsing-remitting Multiple Scler
Official Title ICMJE	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
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
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition ICMJE	Relapsing-remitting Multiple Sclerosis; RRMS
Intervention ICMJE	Drug: AIN457 infusion 10 mg/Kg; Drug: Placebo infusion
Study Arms	Experimental: AIN457 Intervention: Drug: AIN457; Placebo Comparator: Placebo Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: April 27, 2012)	73
Original Estimated Enrollment ICMJE; (submitted: January 19, 2010)	88
Actual Study Completion Date	April 2012
Actual Primary Completion Date	April 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Exclusion Criteria:
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 55 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Czech Republic, Russian Federation, Ukraine
Removed Location Countries	Serbia, Sweden
Administrative Information
NCT Number ICMJE	NCT01051817
Other Study ID Numbers ICMJE	CAIN457B2201; 2009-011626-34
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Novartis ( Novartis Pharmaceuticals )
Study Sponsor ICMJE	Novartis Pharmaceuticals
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account	Novartis
Verification Date	February 2015
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP