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A Phase 2 Study of Interferon Beta-1a (Avonex®) in Ulcerative Colitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00616434
First Posted: February 15, 2008
Last Update Posted: August 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Biogen
Results First Submitted: July 23, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition: Active Ulcerative Colitis
Interventions: Drug: BG9418 (Interferon beta-1a)
Drug: Placebo

  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
Interferon Beta-1a Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks
Placebo Placebo IM injection twice weekly for 12 weeks

Participant Flow:   Overall Study
    Interferon Beta-1a   Placebo
STARTED   62   61 
COMPLETED   56   53 
NOT COMPLETED   6   8 
Adverse Event                5                2 
Physician Decision                0                4 
Withdrawal by Subject                1                1 
Protocol deviation                0                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
Interferon Beta-1a Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks
Placebo Placebo IM injection twice weekly for 12 weeks
Total Total of all reporting groups

Baseline Measures
   Interferon Beta-1a   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 62   61   123 
Age 
[Units: Years]
Mean (Full Range)
 41.1 
 (21 to 64) 
 41.0 
 (20 to 65) 
 41.0 
 (20 to 65) 
Gender 
[Units: Participants]
     
Female   19   26   45 
Male   43   35   78 


  Outcome Measures
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1.  Primary:   Percentage of Participants With a Clinical Response   [ Time Frame: Baseline and Week 8 ]

2.  Secondary:   Number of Participants With Adverse Events (AEs)   [ Time Frame: Up to 16 weeks ]

3.  Secondary:   Percentage of Participants With a Decrease on Simple Clinical Colitis Activity Index (SCCAI) of ≥3 Points at Week 8   [ Time Frame: Baseline and Week 8 ]


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



Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT00616434     History of Changes
Obsolete Identifiers: NCT00750490
Other Study ID Numbers: 108UC201
2007-004867-22 ( EudraCT Number )
First Submitted: February 5, 2008
First Posted: February 15, 2008
Results First Submitted: July 23, 2014
Results First Posted: August 13, 2014
Last Update Posted: August 13, 2014