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Rilonacept to Improve Artery Function in Patients With Atherosclerosis

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ClinicalTrials.gov Identifier: NCT00417417
Recruitment Status : Completed
First Posted : January 1, 2007
Results First Posted : April 13, 2010
Last Update Posted : April 30, 2012
Sponsor:
Information provided by (Responsible Party):
Richard Cannon, National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Coronary Artery Disease
Atherosclerosis
Inflammation
Endothelial Dysfunction
Interventions Drug: Rilonacept
Drug: Placebo
Enrollment 10
Recruitment Details Patients with coronary artery disease were recruited from the Clinical Center outpatient clinic, and began in January, 2007.
Pre-assignment Details  
Arm/Group Title Rilonacept Placebo
Hide Arm/Group Description rilonacept 320 mg injected every 2 weeks x4 administrations. placebo injected every two weeks x 4 administrations
Period Title: Overall Study
Started 4 6
Completed 4 6
Not Completed 0 0
Arm/Group Title Rilonacept Placebo Total
Hide Arm/Group Description rilonacept 320 mg injected every 2 weeks x4 administrations. placebo injected every two weeks for two months Total of all reporting groups
Overall Number of Baseline Participants 4 6 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 6 participants 10 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
  50.0%
2
  33.3%
4
  40.0%
>=65 years
2
  50.0%
4
  66.7%
6
  60.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 6 participants 10 participants
64  (11) 71  (10) 69  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 6 participants 10 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
4
 100.0%
6
 100.0%
10
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 6 participants 10 participants
4 6 10
C-reactive protein  
Mean (Standard Deviation)
Unit of measure:  mg/L
Number Analyzed 4 participants 6 participants 10 participants
3.6  (1.8) 3.9  (1.1) 3.8  (1.5)
1.Primary Outcome
Title C-Reactive Protein (CRP)
Hide Description C-reactive protein levels in subjects randomized to rilonacept versus placebo injections.
Time Frame 2 wks following last drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Rilonacept Placebo
Hide Arm/Group Description:
rilonacept 320 mg x 4 administrations over 8 weeks.
Placebo x 4 injections over 8 weeks
Overall Number of Participants Analyzed 4 6
Mean (Standard Deviation)
Unit of Measure: mg/L
3.7  (3.6) 4.6  (2.7)
2.Other Pre-specified Outcome
Title Brachial Artery Flow-mediated Dilation
Hide Description Brachial artery flow-mediated dilation in respone to 5 minutes of forearm ischemia
Time Frame Two weeks following final administration of drug
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol
Arm/Group Title Rilonacept Placebo
Hide Arm/Group Description:
Rilonacept 320 mg subcutaneously x4 over 8 weeks
Placebo subcutaneous injection x 4 over 8 weeks
Overall Number of Participants Analyzed 4 6
Mean (Standard Deviation)
Unit of Measure: percent change
6.3  (4.8) 6.5  (3.6)
Time Frame Two years.
Adverse Event Reporting Description 81 year-old man experienced viral upper respiratory infection following the second injection of the study drug. Because of rapid resolution of symptoms, he continued to receive the final two study injections, without incident. This adverse event was reported to the DSMB, the IRB, the FDA and Regeneron on April 16, 2007.
 
Arm/Group Title Rilonacept Placebo
Hide Arm/Group Description rilonacept 320 mg injected every 2 weeks x4 administrations. placebo injected every two weeks for two months
All-Cause Mortality
Rilonacept Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Rilonacept Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      1/6 (16.67%)    
Respiratory, thoracic and mediastinal disorders     
Upper respiratory infection  [1]  0/4 (0.00%)  0 1/6 (16.67%)  1
Indicates events were collected by systematic assessment
[1]
81 year-old man who experienced viral upper respiratory infection following the second injection of placebo. Because of rapid resolution of symptoms, he continued to receive the final two study injections, without incident.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rilonacept Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      0/6 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Richard O. Cannon III, MD
Organization: NHLBI/NIH
Phone: 301-496-9895
Responsible Party: Richard Cannon, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00417417     History of Changes
Other Study ID Numbers: 070055
07-H-0055 ( Other Identifier: NIH Clinical Center protocol 07-H-0055 )
First Submitted: December 29, 2006
First Posted: January 1, 2007
Results First Submitted: September 14, 2009
Results First Posted: April 13, 2010
Last Update Posted: April 30, 2012