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Interferon-beta1a (AVONEX) Treatment of Ulcerative Colitis
This study has been completed.
Study NCT00048347   Information provided by National Institutes of Health Clinical Center (CC)

First Received on October 29, 2002.   Last Updated on August 30, 2010   History of Changes
Results First Received: July 6, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Ulcerative Colitis
Intervention: Drug: AVONEX

  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
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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
Avonex 30 µg IM every week for 12 weeks

Participant Flow:   Overall Study
    Avonex  
STARTED     18  
COMPLETED     16  
NOT COMPLETED     2  
Screen failure                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Avonex 30 µg IM every week for 12 weeks

Baseline Measures
    Avonex  
Number of Participants  
[units: participants]
 		  18  
Age  
[units: participants]
 		 
<=18 years     1  
Between 18 and 65 years     16  
>=65 years     1  
Age  
[units: years]
Mean ± Standard Deviation 		  39.4  ± 4.3  
Gender  
[units: participants]
 		 
Female     8  
Male     10  
Region of Enrollment  
[units: participants]
 		 
United States     18  



  Outcome Measures

1.  Primary:   Percent of Participants With at Least a 3 Point Drop in the Short Clinical Colitis Score (SCCAI)   [ Time Frame: Baseline, Week 12 ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
While this study was designed as a proof-of-concept pilot trial to correlate changes in IL-13 and other cytokines with clinical response, efficacy was measured. The efficacy estimate is limited by the open-label design.  


Results Point of Contact:  
Name/Title: Peter Mannon, MD
Organization: NIAID
phone: 205-934-4726
e-mail: pmannon@uab.edu


Publications:
Duchmann R, May E, Heike M, Knolle P, Neurath M, Meyer zum Buschenfelde KH. T cell specificity and cross reactivity towards enterobacteria, bacteroides, bifidobacterium, and antigens from resident intestinal flora in humans. Gut. 1999 Jun;44(6):812-8.


Responsible Party: Peter Mannon, M.D./National Institute of Allergy and Infectious Diseases, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00048347     History of Changes
Other Study ID Numbers: 030019, 03-I-0019
Study First Received: October 29, 2002
Results First Received: July 6, 2010
Last Updated: August 30, 2010
Health Authority: United States: Federal Government





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