Natalizumab Re-Initiation of Dosing

This study has been completed.
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00306592
First received: January 31, 2006
Last updated: December 20, 2009
Last verified: December 2009
Results First Received: June 30, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Sclerosis, Relapsing-Remitting
Intervention: Drug: Natalizumab

  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
First treatment: 30 March 2006; Study completion: 18 February 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
404 subjects started in study 101MS322. They are included in the total of 1094 subjects described in this presentation of combined data from studies 101MS321 and 101MS322.

Reporting Groups
  Description
300 mg Natalizumab IV Monthly All study participants

Participant Flow:   Overall Study
    300 mg Natalizumab IV Monthly  
STARTED     1094 [1]
COMPLETED     1028  
NOT COMPLETED     66  
[1] 404 subjects started in Study 101MS322 and are included in the combined study data.



  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
300 mg Natalizumab IV Monthly All study participants

Baseline Measures
    300 mg Natalizumab IV Monthly  
Number of Participants  
[units: participants]
  1094  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     1094  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  41.4  ± 8.12  
Gender  
[units: participants]
 
Female     755  
Male     339  
Region of Enrollment  
[units: participants]
 
United States     356  
Canada     48  
Australia     24  
Belgium     19  
Czech Republic     107  
Denmark     9  
Finland     10  
France     64  
Germany     22  
Greece     4  
Hungary     47  
Ireland     8  
Israel     10  
Italy     16  
Netherlands     52  
New Zealand     9  
Poland     122  
Spain     31  
Sweden     23  
Switzerland     11  
Turkey     29  
United Kingdom     73  



  Outcome Measures
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1.  Primary:   Number of Subjects With Adverse Events   [ Time Frame: 48 weeks ]

2.  Primary:   Number of Subjects With Hypersensitivity-Related Adverse Events   [ Time Frame: 48 weeks ]

3.  Primary:   Number of Subjects With Persistent Antibodies to Natalizumab   [ Time Frame: 48 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Biogen Idec Study Medical Director
Organization: Biogen Idec
phone: +1 617 679 2000
e-mail: neurologyclinicaltrials@biogenidec.com


No publications provided


Responsible Party: Biogen Idec MD, Biogen Idec, Inc.
ClinicalTrials.gov Identifier: NCT00306592     History of Changes
Other Study ID Numbers: 101-MS-322
Study First Received: January 31, 2006
Results First Received: June 30, 2009
Last Updated: December 20, 2009
Health Authority: United States: Food and Drug Administration
Canada: Health Canada