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Anakinra for Behcet s Disease

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ClinicalTrials.gov Identifier: NCT01441076
Recruitment Status : Completed
First Posted : September 27, 2011
Results First Posted : May 12, 2017
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) )

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
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Anakinra
Hide Arm/Group Description Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
Period Title: Overall Study
Started 6
Completed 4
Not Completed 2
Arm/Group Title Anakinra
Hide Arm/Group Description Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
LTE18
0
   0.0%
BTWN
6
 100.0%
GTE65
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
5
  83.3%
Male
1
  16.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Hispanic
0
   0.0%
Not Hispanic or Latino
6
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 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%
1.Primary Outcome
Title Clinical Remission From Months 3-6
Hide Description Clinical remission was defined as no oral or vaginal ulcers on physical examination for 2 consecutive monthly visits from months 3-6.
Time Frame Monthly study visits from months 3-6 during the trial
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.
Arm/Group Title Anakinra
Hide Arm/Group Description:
Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: Participants
2
2.Secondary Outcome
Title Behcet's Disease Related Quality of Life (BDRQOL) Assessment Score
Hide Description The BDRQOL is a standardized assessment form in Behcet's disease composed of 30 items (answered true or not true) and each item is scored 0 or 1 (scoring range from 0 to 30). A total lower score indicates a better quality of life and a total higher score indicates a worse quality of life.
Time Frame Month 6 study visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.
Arm/Group Title Anakinra
Hide Arm/Group Description:
Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: Units on a scale
9.5
(0 to 22)
3.Secondary Outcome
Title Behcet's Syndrome Activity Scale (BSAS) Score
Hide Description The BSAS is a standardized assessment form in Behcet's disease. The BSAS score comprises 10 items. The total score possible is between 0-100. A total lower score indicates a less syndrome activity and a higher total score indicates more syndrome activity.
Time Frame Month 6 study visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.
Arm/Group Title Anakinra
Hide Arm/Group Description:
Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: Units on a scale
21.3
(0 to 44)
4.Secondary Outcome
Title Behcets Disease Current Activity Form (BDCAF) Score
Hide Description The BDCAF is a standardized assessment form in Behcet's disease to measure patient activity. Scoring is based on the history of new clinical features present over the preceding 4 weeks prior to assessment. The range of score is 0 - 12. A total lower score indicates less disease activity and a higher total score indicates more disease activity.
Time Frame Month 6 study visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.
Arm/Group Title Anakinra
Hide Arm/Group Description:
Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: Units on a scale
5
(4 to 6)
5.Secondary Outcome
Title Number of Genital Ulcers by Physician Evaluation
Hide Description Number of genital ulcers noted by physician evaluation
Time Frame Month 6 study visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.
Arm/Group Title Anakinra
Hide Arm/Group Description:
Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: genital ulcers in participants
0
(0 to 0)
6.Secondary Outcome
Title Number of Oral Ulcers by Physician Evaluation
Hide Description Number of oral ulcers noted by physician evaluation
Time Frame Month 6 study visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.
Arm/Group Title Anakinra
Hide Arm/Group Description:
Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: oral ulcers in participants
0.5
(0 to 2)
7.Secondary Outcome
Title Patient Global Score
Hide Description Global visual analogue scale taken by patients with a range of score of 0-100. Lower scores indicate least symptoms and higher scores indicate worst symptoms faced by the patient.
Time Frame Month 6 study visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.
Arm/Group Title Anakinra
Hide Arm/Group Description:
Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: Units on a scale
51.5
(3 to 91)
8.Secondary Outcome
Title Physician Global Score
Hide Description Global visual analogue scale administered by physicians with a range of score of 0-100. Lower scores indicate least symptoms and higher scores indicate worst symptoms faced by the patient.
Time Frame Month 6 study visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.
Arm/Group Title Anakinra
Hide Arm/Group Description:
Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: Units on a scale
8.5
(7 to 24)
9.Secondary Outcome
Title Behcet's Disease Related Quality of Life (BDRQOL) Assessment Score
Hide Description The BDRQOL is a standardized assessment form in Behcet's disease composed of 30 items (answered true or not true) and each item is scored 0 or 1 (scoring range from 0 to 30). A total lower score indicates a better quality of life and a total higher score indicates a worse quality of life.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.
Arm/Group Title Anakinra
Hide Arm/Group Description:
Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: Units on a scale
16
(10 to 24)
10.Secondary Outcome
Title Behcet's Syndrome Activity Scale (BSAS) Score
Hide Description The BSAS is a standardized assessment form in Behcet's disease. The BSAS score comprises 10 items. The total score possible is between 0-100. A total lower score indicates a less syndrome activity and a higher total score indicates more syndrome activity.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.
Arm/Group Title Anakinra
Hide Arm/Group Description:
Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: Units on a scale
46
(22 to 80.5)
11.Secondary Outcome
Title Behcets Disease Current Activity Form (BDCAF) Score
Hide Description The BDCAF is a standardized assessment form in Behcet's disease to measure patient activity. Scoring is based on the history of new clinical features present over the preceding 4 weeks prior to assessment. The range of score is 0 - 12. A total lower score indicates less disease activity and a higher total score indicates more disease activity.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.
Arm/Group Title Anakinra
Hide Arm/Group Description:
Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: Units on a scale
6
(5 to 11)
12.Secondary Outcome
Title Number of Genital Ulcers by Physician Evaluation
Hide Description Number of genital ulcers noted by physician evaluation
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.
Arm/Group Title Anakinra
Hide Arm/Group Description:
Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: genital ulcers in participants
0
(0 to 3)
13.Secondary Outcome
Title Number of Oral Ulcers by Physician Evaluation
Hide Description Number of oral ulcers noted by physician evaluation
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.
Arm/Group Title Anakinra
Hide Arm/Group Description:
Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: oral ulcers in participants
3.5
(2 to 5)
14.Secondary Outcome
Title Patient Global Score
Hide Description Global visual analogue scale taken by patients with a range of score of 0-100. Lower scores indicate least symptoms and higher scores indicate worst symptoms faced by the patient.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.
Arm/Group Title Anakinra
Hide Arm/Group Description:
Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: Units on a scale
73.5
(9 to 90)
15.Secondary Outcome
Title Physician Global Score
Hide Description Global visual analogue scale administered by physicians with a range of score of 0-100. Lower scores indicate least symptoms and higher scores indicate worst symptoms faced by the patient.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.
Arm/Group Title Anakinra
Hide Arm/Group Description:
Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: Units on a scale
16.5
(12 to 79)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Anakinra
Hide Arm/Group Description Treatment with Anakinra 100mg subcutaneous daily
All-Cause Mortality
Anakinra
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Anakinra
Affected / at Risk (%)
Total   1/6 (16.67%) 
Musculoskeletal and connective tissue disorders   
Chest wall pain  1/6 (16.67%) 
Nervous system disorders   
Presyncope  1/6 (16.67%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary hypertension  1/6 (16.67%) 
Vascular disorders   
Thromboembolic event  1/6 (16.67%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Anakinra
Affected / at Risk (%)
Total   6/6 (100.00%) 
Blood and lymphatic system disorders   
Anemia  1/6 (16.67%) 
Eye disorders   
Blurred vision  1/6 (16.67%) 
Eye disorders - Other, specify  1/6 (16.67%) 
Gastrointestinal disorders   
Abdominal pain  2/6 (33.33%) 
General disorders   
Edema limbs  2/6 (33.33%) 
Fatigue  1/6 (16.67%) 
Immune system disorders   
Allergic reaction  4/6 (66.67%) 
Infections and infestations   
Bronchial Infection  1/6 (16.67%) 
Infections and infestations - Other, specify  1/6 (16.67%) 
Pharyngitis  1/6 (16.67%) 
Rhinitis infective  2/6 (33.33%) 
Upper respiratory infection  2/6 (33.33%) 
Vaginal infection  1/6 (16.67%) 
Vulval infection  1/6 (16.67%) 
Metabolism and nutrition disorders   
Hypoglycemia  1/6 (16.67%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1/6 (16.67%) 
Pain in extremity  1/6 (16.67%) 
Nervous system disorders   
Dizziness  1/6 (16.67%) 
Psychiatric disorders   
Mania  1/6 (16.67%) 
Renal and urinary disorders   
Urinary Frequency  1/6 (16.67%) 
Respiratory, thoracic and mediastinal disorders   
Sore throat  1/6 (16.67%) 
Skin and subcutaneous tissue disorders   
Alopecia  2/6 (33.33%) 
Vascular disorders   
Phlebitis  1/6 (16.67%) 
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
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