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The Multicenter, Open-label, Single-use Autoinjector Convenience Study

This study has been completed.
Sponsor:
Information provided by:
EMD Serono
ClinicalTrials.gov Identifier:
NCT00958009
First received: August 12, 2009
Last updated: August 2, 2013
Last verified: August 2013
Results First Received: December 1, 2010  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Multiple Sclerosis
Intervention: Device: Rebidose®

  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
109 subjects were recruited from 12 US clinics in the US during the trial period Oct 2009 to April 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects who signed informed consent and satisfied the eligibility critera at screening returned to the clinic on study day 1 to begin treatment. All subjects participating in the trial received Rebif 44 mcg subcutaneious (sc, three times per week (tiw) using the single-use autoinjector (SA).

Reporting Groups
  Description
RMS Subject Disposition Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication

Participant Flow:   Overall Study
    RMS Subject Disposition  
STARTED     109  
COMPLETED     107  
NOT COMPLETED     2  
Adverse Event                 1  
Subject found device difficult to use                 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
RMS Subject Disposition Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication

Baseline Measures
    RMS Subject Disposition  
Number of Participants  
[units: participants]
  109  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     109  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  46.0  ± 9.32  
Gender  
[units: participants]
 
Female     76  
Male     33  
Region of Enrollment  
[units: participants]
 
United States     109  



  Outcome Measures
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1.  Primary:   Proportion of Relapsing Multiple Sclerosis (RMS) Subjects Rating the Single-use Autoinjector as 'Easy to Use' or 'Very Easy to Use' for Self-injection in a User Trial Questionnaire   [ Time Frame: at 12 weeks ]

2.  Secondary:   Multiple Secondary Endpoints Were Assessed, Based on Questions From the User Trial Questionnaire Related to the Single-use Autoinjector Device Use-related Outcomes.   [ Time Frame: at 12 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
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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: Fernando Dangond, MD
Organization: EMD Serono, Inc.
phone: 781-681-2348
e-mail: Fernando.dangond@emdserono.com


No publications provided


Responsible Party: Fernando Dangond, , Senior Director, Medical Affairs Neurology, EMD Serono, Inc.
ClinicalTrials.gov Identifier: NCT00958009     History of Changes
Other Study ID Numbers: 29651
Study First Received: August 12, 2009
Results First Received: December 1, 2010
Last Updated: August 2, 2013
Health Authority: United States: Food and Drug Administration