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Rebif® Pregnancy Registry

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT00338741
First received: June 16, 2006
Last updated: August 23, 2011
Last verified: August 2011
History of Changes
Results First Received: April 30, 2010  
Study Type: Observational
Study Design: Observational Model: Case Control;   Time Perspective: Prospective
Condition: Multiple Sclerosis

  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
35 physicians in clinical practice in the United States participated in the Registry. Physicians were practicing obstetricians and neurologists who evaluated the subjects as part of their clinical practices.Between 30 Sep 2002 to 15 Feb 2008, 207 subjects were contacted about the Registry. Enrollment was terminated on 07 Dec 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Rebif Exposed Pregnancies Women with multiple sclerosis (MS) who were exposed to Rebif (interferon-beta [IFN-beta]-1a) during pregnancy or within one week of conception
Non-Rebif Exposed Pregnancies Women with MS who had not received any IFN-beta therapy during pregnancy or within 90 days of conception

Participant Flow:   Overall Study
    Rebif Exposed Pregnancies     Non-Rebif Exposed Pregnancies  
STARTED     34 [1]   2  
COMPLETED     32     2  
NOT COMPLETED     2     0  
Lost to Follow-up                 2                 0  
[1] 2 subjects signed a consent form but no data were received for either subject



  Baseline Characteristics
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Reporting Groups
  Description
Rebif Exposed Pregnancies Women with multiple sclerosis (MS) who were exposed to Rebif (interferon-beta [IFN-beta]-1a) during pregnancy or within one week of conception
Non-Rebif Exposed Pregnancies Women with MS who had not received any IFN-beta therapy during pregnancy or within 90 days of conception
Total Total of all reporting groups

Baseline Measures
    Rebif Exposed Pregnancies     Non-Rebif Exposed Pregnancies     Total  
Number of Participants  
[units: participants]
 		  34     2     36  
Age  
[units: participants]
 		     
<=18 years     1     0     1  
Between 18 and 65 years     33     2     35  
>=65 years     0     0     0  
Gender  
[units: participants]
 		     
Female     34     2     36  
Male     0     0     0  
Region of Enrollment  
[units: participants]
 		     
United States     34     2     36  



  Outcome Measures
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1.  Primary:   Spontaneous Abortion   [ Time Frame: Up to 9 months ]
  Show Outcome Measure 1

2.  Secondary:   Fetal Death/Stillbirth   [ Time Frame: Up to 10 months ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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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.


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
Despite a consistent and exhaustive expenditure of resources over 5 years only 36 subjects were enrolled into the Registry, a number which precludes meaningful statistical analysis of the potential risks of Rebif® during pregnancy.  


Results Point of Contact:  
Name/Title: Liz Gedney/Clinical Trial Leader
Organization: EMD Serono
phone: +781 681-2179


No publications provided


Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT00338741     History of Changes
Other Study ID Numbers: 23888
Study First Received: June 16, 2006
Results First Received: April 30, 2010
Last Updated: August 23, 2011
Health Authority: United States: Food and Drug Administration