Status:
COMPLETED
Rilonacept to Improve Artery Function in Patients With Atherosclerosis
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Coronary Artery Disease
Atherosclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will determine whether an experimental drug called Rilonacept can improve artery function in patients with atherosclerosis, a disease in which fatty deposits in arteries cause the vessels t...
Detailed Description
Rilonacept (Interleukin-1 Trap) has been developed as an antagonist of the cytokine IL-1 in the treatment of rheumatoid arthritis and other inflammatory diseases. IL-1 causes leukocyte accumulation by...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Male and non-pregnant female subjects over 18 years of age
- Diagnosis of atherosclerotic CAD by coronary angiography
- High sensitivity C-reactive protein (hsCRP) between 2.0 and 10.0 g/L, inclusive with percent change in CRP from Visit 1 to Visit 2 of less than 50% to +100%.
- Taking a HMG-CoA reductase inhibitor -For men and women of childbearing potential, willingness to utilize adequate contraception
- Willing, at time of study enrollment, to return for all clinic visits specified in the protocol and complete all study-related procedures.
- EXCLUSION CRITERIA:
- BMI (body mass index) greater than 49.9 kg/m2 at Screening Visit 1 -Vascular intervention within 60 days prior to Screening Visit 1.
- Infection, use of systemic antibiotics, or clinically significant trauma (including surgery) within 30 days prior to Screening Visit 1.
- History or evidence of acute coronary syndrome within 60 days prior to Screening Visit 1.
- Acute or chronic inflammatory condition other than atherosclerosis
- Recently diagnosed diabetes mellitus
- Clinical evidence of congestive heart failure NYHA Class III-IV
- History of hypersensitivity other than localized injection site reaction to any biologic agent.
- Use of a thiazolidinedione
- Use of immunosuppressive or immunomodulatory medication (use of an inhaled glucocorticoid is permitted).
- Prior use of an immunomodulatory biologic drug within the last 6 months except immunizations and biologics used as standard care in cardiac care settings.
- Received a live/live attenuated vaccine within 90 days prior to Screening Visit 1 or other immunization within 30 days prior to Screening Visit 1.
- Prior or planned organ transplant recipient.
- Severe respiratory disease
- A history of tuberculosis infection, history of a positive skin test for tuberculosis, or a chest radiograph at Screening Visit 1 consistent with prior tuberculosis infection
- Positive result (5 mm or more in duration at 48 to 72 hours post-placement) of the PPD 5 TU placed at Screening Visit 2
- History or presence of malignancy (except for successfully treated basal cell carcinoma of the skin or in situ carcinoma of the cervix) within the past 5 years.
- HIV positive.
- Hepatitis B surface antigen or Hepatitis C antibody positive
- ALT, AST or alkaline phosphatase greater than twice the upper limit of the normal range, serum creatinine or total bilirubin greater than 1.5 times the upper limit of normal at Screening Visit 1.
- Hemoglobin less than 11.0 gm/dL, white blood cell (WBC) count less than 3,000/mm3, neutrophil count less than 2000/mm3 or platelet count less than 100,000/mm3 at Screening Visit 1.
- Participation in any clinical research study evaluating another investigational drug or therapy within 30 days prior to Screening Visit 1.
- History of substance abuse
- Elective surgery or vascular intervention planned to occur during the study.
- Any medical condition which would interfere with participation in the study, interfere with interpretation of study outcome measures, or place the subject at risk.
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00417417
Start Date
December 1 2006
End Date
April 1 2008
Last Update
April 30 2012
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892