Trial record 1 of 1 for:    Randomized Treatment Interruption of Natalizumab
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Treatment Interruption of Natalizumab (RESTORE)

This study has been completed.
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01071083
First received: February 17, 2010
Last updated: September 12, 2013
Last verified: November 2012
Results First Received: October 25, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Relapsing Remitting Multiple Sclerosis
Interventions: Drug: natalizumab
Drug: interferon beta 1-a
Drug: methylprednisolone
Other: IV placebo
Drug: glatiramer acetate

  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
Date of first treatment: 31 March 2010. Date of study completion: 02 November 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
175 subjects were enrolled, all 175 were randomized.

Reporting Groups
  Description
Intravenous Placebo placebo matching natalizumab, intravenous every 4 weeks
Natalizumab 300 mg intravenous every 4 weeks
Interferon β-1a 30 ug intramuscular once per week
Glatiramer Acetate 20 mg subcutaneous once daily
Methylprednisolone 1000 mg intravenous every 4 weeks

Participant Flow:   Overall Study
    Intravenous Placebo     Natalizumab     Interferon β-1a     Glatiramer Acetate     Methylprednisolone  
STARTED     42     45     17     17     54  
COMPLETED     35     43     12     15     46  
NOT COMPLETED     7     2     5     2     8  
Adverse Event                 1                 0                 1                 0                 1  
Withdrawal by Subject                 3                 0                 2                 0                 3  
Physician Decision                 1                 0                 0                 1                 1  
Early Rescue                 1                 0                 0                 0                 1  
Subject Moved                 0                 1                 0                 0                 0  
Images Not Usable (Motion)                 0                 1                 0                 0                 0  
Did Not Meet Eligibility Criteria                 0                 0                 1                 1                 1  
Did Not Want Per Protocol Treatment                 0                 0                 1                 0                 1  
Subject Refused to Continue                 1                 0                 0                 0                 0  



  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 intravenous every 4 weeks
Intravenous Placebo placebo matching natalizumab, intravenous every 4 weeks
Interferon β-1a 30 ug intramuscular once per week
Glatiramer Acetate 20 mg subcutaneous once daily
Methylprednisolone 1000 mg intravenous every 4 weeks
Total Total of all reporting groups

Baseline Measures
    Natalizumab     Intravenous Placebo     Interferon β-1a     Glatiramer Acetate     Methylprednisolone     Total  
Number of Participants  
[units: participants]
  45     42     17     17     54     175  
Age  
[units: Years]
Mean ± Standard Deviation
  41.2  ± 9.70     40.0  ± 10.36     45.1  ± 9.92     44.1  ± 7.85     40.1  ± 9.96     41.2  ± 9.85  
Gender  
[units: Participants]
           
Female     37     31     14     14     39     135  
Male     8     11     3     3     15     40  



  Outcome Measures
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1.  Primary:   Time Course to Return of Radiological and/or Clinical Evidence of Multiple Sclerosis Activity, as Measured by the Percentage of Subjects Who Met Magnetic Resonance Imaging (MRI) and/or Clinical Relapse Rescue Criteria.   [ Time Frame: 28 Weeks ]

2.  Secondary:   Time Course to Return of Radiological Activity, as Measured by the Percentage of Subjects Who Met Magnetic Resonance Imaging (MRI) Rescue Criteria.   [ Time Frame: 28 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
No text entered.


  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 Medical Director
Organization: Biogen Idec Inc
phone: 1-617-679-2000
e-mail: neurologyclinicaltrials@biogenidec.com


No publications provided


Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01071083     History of Changes
Other Study ID Numbers: 101MS205
Study First Received: February 17, 2010
Results First Received: October 25, 2012
Last Updated: September 12, 2013
Health Authority: United States: Food and Drug Administration