Trial Outcomes & Findings for Rilonacept to Improve Artery Function in Patients With Atherosclerosis (NCT NCT00417417)

NCT ID: NCT00417417

Last Updated: 2012-04-30

Results Overview

C-reactive protein levels in subjects randomized to rilonacept versus placebo injections.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 10 participants
• Primary outcome timeframe: 2 wks following last drug administration
• Results posted on: 2012-04-30

Participant Flow

Patients with coronary artery disease were recruited from the Clinical Center outpatient clinic, and began in January, 2007.

Participant milestones

Measure	Rilonacept rilonacept 320 mg injected every 2 weeks x4 administrations.	Placebo placebo injected every two weeks x 4 administrations
Overall Study STARTED	4	6
Overall Study COMPLETED	4	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rilonacept to Improve Artery Function in Patients With Atherosclerosis

Baseline characteristics by cohort

Measure	Rilonacept n=4 Participants rilonacept 320 mg injected every 2 weeks x4 administrations.	Placebo n=6 Participants placebo injected every two weeks for two months	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Age Continuous	64 years STANDARD_DEVIATION 11 • n=5 Participants	71 years STANDARD_DEVIATION 10 • n=7 Participants	69 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	6 participants n=7 Participants	10 participants n=5 Participants
C-reactive protein	3.6 mg/L STANDARD_DEVIATION 1.8 • n=5 Participants	3.9 mg/L STANDARD_DEVIATION 1.1 • n=7 Participants	3.8 mg/L STANDARD_DEVIATION 1.5 • n=5 Participants

PRIMARY outcome

Timeframe: 2 wks following last drug administration

Population: per protocol

C-reactive protein levels in subjects randomized to rilonacept versus placebo injections.

Outcome measures

Measure	Rilonacept n=4 Participants rilonacept 320 mg x 4 administrations over 8 weeks.	Placebo n=6 Participants Placebo x 4 injections over 8 weeks
C-Reactive Protein (CRP)	3.7 mg/L Standard Deviation 3.6	4.6 mg/L Standard Deviation 2.7

OTHER_PRE_SPECIFIED outcome

Timeframe: Two weeks following final administration of drug

Population: Per protocol

Brachial artery flow-mediated dilation in respone to 5 minutes of forearm ischemia

Outcome measures

Measure	Rilonacept n=4 Participants rilonacept 320 mg x 4 administrations over 8 weeks.	Placebo n=6 Participants Placebo x 4 injections over 8 weeks
Brachial Artery Flow-mediated Dilation	6.3 percent change Standard Deviation 4.8	6.5 percent change Standard Deviation 3.6

Adverse Events

Rilonacept

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Rilonacept n=4 participants at risk rilonacept 320 mg injected every 2 weeks x4 administrations.	Placebo n=6 participants at risk placebo injected every two weeks for two months
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	0.00% 0/4 • Two years. 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.	16.7% 1/6 • Number of events 1 • Two years. 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.

Other adverse events

Adverse event data not reported

Additional Information

Richard O. Cannon III, MD

NHLBI/NIH

Phone: 301-496-9895

Email: cannonr@nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place