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Anakinra for Behcet s Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01441076
First Posted: September 27, 2011
Last Update Posted: May 12, 2017
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):
National Institutes of Health Clinical Center (CC) ( National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) )
Results First Submitted: April 5, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Autoimmune Connective Tissue Disorder
Immune System Diseases
Intervention: Drug: Anakinra

  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
Anakinra Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily

Participant Flow:   Overall Study
    Anakinra
STARTED   6 
COMPLETED   4 
NOT COMPLETED   2 



  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.
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Reporting Groups
  Description
Anakinra Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily

Baseline Measures
   Anakinra 
Overall Participants Analyzed 
[Units: Participants]
 6 
Age 
[Units: Participants]
Count of Participants
 
LTE18      0   0.0% 
BTWN      6 100.0% 
GTE65      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      5  83.3% 
Male      1  16.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic      0   0.0% 
Not Hispanic or Latino      6 100.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Hawaiian      0   0.0% 
Black      1  16.7% 
White      4  66.7% 
More than one race      1  16.7% 
Unknown or Not Reported      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Clinical Remission From Months 3-6   [ Time Frame: Monthly study visits from months 3-6 during the trial ]

2.  Secondary:   Behcet's Disease Related Quality of Life (BDRQOL) Assessment Score   [ Time Frame: Month 6 study visit ]

3.  Secondary:   Behcet's Syndrome Activity Scale (BSAS) Score   [ Time Frame: Month 6 study visit ]

4.  Secondary:   Behcets Disease Current Activity Form (BDCAF) Score   [ Time Frame: Month 6 study visit ]

5.  Secondary:   Number of Genital Ulcers by Physician Evaluation   [ Time Frame: Month 6 study visit ]

6.  Secondary:   Number of Oral Ulcers by Physician Evaluation   [ Time Frame: Month 6 study visit ]

7.  Secondary:   Patient Global Score   [ Time Frame: Month 6 study visit ]

8.  Secondary:   Physician Global Score   [ Time Frame: Month 6 study visit ]

9.  Secondary:   Behcet's Disease Related Quality of Life (BDRQOL) Assessment Score   [ Time Frame: Baseline ]

10.  Secondary:   Behcet's Syndrome Activity Scale (BSAS) Score   [ Time Frame: Baseline ]

11.  Secondary:   Behcets Disease Current Activity Form (BDCAF) Score   [ Time Frame: Baseline ]

12.  Secondary:   Number of Genital Ulcers by Physician Evaluation   [ Time Frame: Baseline ]

13.  Secondary:   Number of Oral Ulcers by Physician Evaluation   [ Time Frame: Baseline ]

14.  Secondary:   Patient Global Score   [ Time Frame: Baseline ]

15.  Secondary:   Physician Global Score   [ Time Frame: Baseline ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Grayson, Peter
Organization: National Inst of Arthritis and Musculoskeletal and Skin Diseases
phone: +1 301 827 9187
e-mail: peter.grayson@nih.gov


Publications:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) )
ClinicalTrials.gov Identifier: NCT01441076     History of Changes
Other Study ID Numbers: 110241
11-AR-0241 ( Other Identifier: National Institute of Health )
First Submitted: September 24, 2011
First Posted: September 27, 2011
Results First Submitted: April 5, 2016
Results First Posted: May 12, 2017
Last Update Posted: May 12, 2017