Natalizumab Re-Initiation of Dosing

This study has been completed.
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00306592
First received: January 31, 2006
Last updated: May 1, 2014
Last verified: May 2014
Results First Received: June 30, 2009  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Sclerosis, Relapsing-Remitting
Intervention: Biological: BG00002 (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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.

Reporting Groups
  Description
Natalizumab Study 101-MS-322 (NCT00306592) Open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
Natalizumab Study 101-MS-321 (NCT00297232) Open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 268 weeks. (Week 52 through Week 480 of Study 101-MS-321 (NCT00297232) is considered to be the Long-Term Treatment Period).

Participant Flow:   Overall Study
    Natalizumab Study 101-MS-322 (NCT00306592)     Natalizumab Study 101-MS-321 (NCT00297232)  
STARTED     404     690  
Completed at 24 Weeks     207     0  
Completed Between 24 and 48 Weeks     85     0  
Completed at 48 Weeks     81     632  
Entered 101-MS-321 Extension Study     22     0 [1]
COMPLETED     373     632  
NOT COMPLETED     31     58  
Adverse Event                 8                 15  
Lost to Follow-up                 1                 0  
Noncompliance                 0                 2  
Persistent Antibodies                 6                 3  
Voluntary                 10                 6  
Not Specified                 5                 10  
Unknown                 1                 2  
48-week Treatment Period Ongoing                 0                 20  
[1] pertains to participants transitioning from 101-MS-322 (NCT00306592) study only



  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.
Participants from 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) are combined.

Reporting Groups
  Description
300 mg Natalizumab IV Monthly All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.

Baseline Measures
    300 mg Natalizumab IV Monthly  
Number of Participants  
[units: participants]
  1094  
Age  
[units: years]
Mean ± Standard Deviation
  41.4  ± 8.12  
Age, Customized  
[units: participants]
 
≥ 18 to < 20 years     0  
≥ 20 to < 30 years     98  
≥ 30 to < 40 years     347  
≥ 40 to < 50 years     454  
≥ 50 to < 59 years     195  
>/= 60 years     0  
Gender  
[units: participants]
 
Female     755  
Male     339  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious AEs (SAEs)   [ Time Frame: Baseline through Week 48 ]

2.  Primary:   Number of Participants With Hypersensitivity-related Adverse Events   [ Time Frame: Baseline through Week 48 ]

3.  Primary:   Number of Participants With Antibodies to Natalizumab   [ Time Frame: Baseline (Week 0), Week 4, Week 24 (test was repeated after 8 weeks if positive, to confirm persistence) ]


  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: Biogen Idec Study Medical Director
Organization: Biogen Idec
e-mail: clinicaltrials@biogenidec.com


No publications provided


Responsible Party: Biogen Idec
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: May 1, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada