Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Results First Received: February 12, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Relapsing-remitting Multiple Sclerosis
RRMS
Interventions: Drug: AIN457
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
AIN457 IV dose 10 mg/kg week 0, 2, 4, 8, 12, 16, and 20.
Placebo Placebo IV week 0, 2, 4, 8, 12, 16, and 20.

Participant Flow:   Overall Study
    AIN457     Placebo  
STARTED     38     35  
COMPLETED     35     26  
NOT COMPLETED     3     9  
Adverse Event                 0                 2  
Abnormal Test Proceedure reults                 0                 1  
Withdrawal by Subject                 3                 5  
Protocol Violation                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
AIN457 IV dose 10 mg/kg week 0, 2, 4, 8, 12, 16, and 20.
Placebo Placebo IV week 0, 2, 4, 8, 12, 16, and 20.
Total Total of all reporting groups

Baseline Measures
    AIN457     Placebo     Total  
Number of Participants  
[units: participants]
  38     35     73  
Age  
[units: years]
Mean ± Standard Deviation
  36.1  ± 9.8     32.7  ± 9.9     34.5  ± 9.95  
Gender  
[units: Participants]
     
Female     21     29     50  
Male     17     6     23  
Ethnicity (NIH/OMB)  
[units: Participants]
     
Hispanic or Latino     3     1     4  
Not Hispanic or Latino     35     34     69  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: Participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     36     33     69  
More than one race     0     0     0  
Unknown or Not Reported     2     2     4  



  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   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). ]

3.  Secondary:   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). ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


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