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A Prospective Study Looking at the Use of Rebif® in Subjects With Clinically Isolated Syndrome (CIS-ON)

This study has been completed.
Sponsor:
Collaborator:
EMD Serono Canada Inc.
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT00287079
First received: February 2, 2006
Last updated: December 2, 2013
Last verified: December 2013
Results First Received: February 2, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Clinically Isolated Syndrome
Interventions: Drug: Rebif®
Other: No Treatment

  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
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Reporting Groups
  Description
Rebif 44 Mcg Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
No Treatment Participants in this group did not receive any treatment.

Participant Flow:   Overall Study
    Rebif 44 Mcg     No Treatment  
STARTED     32     3  
COMPLETED     10     2  
NOT COMPLETED     22     1  
Qualifying relapse                 12                 1  
Non-qualifying relapse                 1                 0  
Adverse Event                 5                 0  
Protocol Violation                 1                 0  
Unspecified                 3                 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
Rebif 44 Mcg Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
No Treatment Participants in this group did not receive any treatment.
Total Total of all reporting groups

Baseline Measures
    Rebif 44 Mcg     No Treatment     Total  
Number of Participants  
[units: participants]
  32     3     35  
Age  
[units: years]
Mean ± Standard Deviation
  36.30  ± 9.68     35.30  ± 13.32     35.80  ± 11.50  
Gender  
[units: participants]
     
Female     19     3     22  
Male     13     0     13  



  Outcome Measures
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1.  Primary:   Time in Month to Clinical Definite Multiple Sclerosis (CDMS) From Kaplan-Meier Estimates   [ Time Frame: Up to Week 96 ]

2.  Secondary:   Percentage of Participants Who Converted to Clinical Definite Multiple Sclerosis (CDMS)   [ Time Frame: Up to Week 96 ]

3.  Secondary:   Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)   [ Time Frame: Up to Week 96 ]


  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: Merck KGaA Communication Center
Organization: Merck Serono, a division of Merck KGaA
phone: +49-6151-72-5200
e-mail: service@merckgroup.com


No publications provided


Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT00287079     History of Changes
Other Study ID Numbers: IMP 26222
Study First Received: February 2, 2006
Results First Received: February 2, 2012
Last Updated: December 2, 2013
Health Authority: Canada: Health Canada