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Natalizumab (Tysabri) Re-Initiation of Dosing (STRATA)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT00297232
First received: February 27, 2006
Last updated: June 16, 2016
Last verified: May 2015
Results First Received: April 21, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Relapsing-Remitting Multiple Sclerosis
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
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 final data.

Note: In the Participant Flow table, 'progressive multifocal leukoencephalopathy' is abbreviated to 'PML'. and John Cunningham virus is abbreviated to 'JCV'.


Reporting Groups
  Description
Natalizumab 300 mg intravenous (IV) infusions once every 4 weeks for up to 480 weeks

Participant Flow:   Overall Study
    Natalizumab
STARTED   1094 
COMPLETED   489 
NOT COMPLETED   605 
Lack of Efficacy                7 
Lost to Follow-up                10 
Adverse Event                63 
Voluntary Withdrawal                120 
Subject was Noncompliant                9 
Death                9 
Anti-natalizumab Positive                8 
Switched to Commercial Tysabri                22 
Disease Progression                8 
Fear of PML                10 
Anti-JCV Antibody Positive                13 
Miscellaneous                5 
Sponsor Decision                34 
Subject Relocated                7 
Subject Withdrew Consent                37 
Persistently Positive Antibodies                11 
Investigator Withdrew From Program                19 
Did Not Enroll to Week 264                34 
Did Not Enroll to Week 480                17 
No data available after Week 264                161 
Other                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
Natalizumab 300 mg IV infusions once every 4 weeks for up to 480 weeks

Baseline Measures
   Natalizumab 
Overall Participants Analyzed 
[Units: Participants]
 1094 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.4  (8.12) 
Age, Customized 
[Units: Years]
 
20 to 29 years   98 
30 to 39 years   347 
40 to 49 years   454 
50 to 59 years   195 
Gender 
[Units: Participants]
 
Female   755 
Male   339 


  Outcome Measures
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1.  Primary:   Time to 24-week Confirmed Expanded Disability Status Scale (EDSS) Progression   [ Time Frame: up to 480 weeks ]

2.  Primary:   Time to 48-week Confirmed EDSS Progression   [ Time Frame: up to 480 weeks ]

3.  Primary:   Time to 24-week Confirmed EDSS Improvement Where Baseline ≥ 2.0   [ Time Frame: Up to 480 weeks ]


  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
Sponsor decided to terminate the study prior to all subjects reaching Week 480 as the primary objective was deemed to have been met and only approximately 45% of the original STRATA population remained in the study at the time of study termination.


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


Publications of Results:

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT00297232     History of Changes
Other Study ID Numbers: 101-MS-321
Study First Received: February 27, 2006
Results First Received: April 21, 2015
Last Updated: June 16, 2016
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Denmark: Danish Medicines Agency
Italy: Ethics Committee
Switzerland: Swissmedic
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Ireland: Irish Medicines Board
Australia: Department of Health and Ageing Therapeutic Goods Administration
Spain: Spanish Agency of Medicines
New Zealand: Medsafe
Czech Republic: State Institute for Drug Control
Greece: National Organization of Medicines
Sweden: Medical Products Agency
Hungary: National Institute of Pharmacy
Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Israel: Ethics Commission
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Finland: Finnish Medicines Agency
Turkey: Ministry of Health
Germany: Paul-Ehrlich-Institut
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)