Trial Outcomes & Findings for Treatment of Acute Pericarditis With Anakinra (NCT NCT03224585)

Last Updated: 2021-02-23

Results Overview

Change from baseline in visual analog pain score from 0 to 10. For this visual analog pain scale, the patient is asked to rate their pain from 0 to 10. A score of 0 represents "no pain", a score of 5 represents "moderate pain", and 10 represents "worst pain".

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

Baseline to 6 hours

Results posted on

2021-02-23

Participant Flow

Participant milestones

Participant milestones
Measure	Anakinra (3 Days) Then Anakinra (4 Days) Period 1 (Time 0-72 hours) - this will be an open-label phase during which all subjects meeting enrollment criteria will receive anakinra 100 mg subcutaneously injections daily for 3 days. Period 2 (Time 72 hours to 7 days) - anakinra 100 mg subcutaneous injections daily for 4 days	Anakinra (3 Days) Then Placebo (4 Days) Period 1 (Time 0-72 hours) - this will be an open-label phase during which all subjects meeting enrollment criteria will receive anakinra 100 mg subcutaneously injections daily for 3 days. Period 2 (Time 72 hours to 7 days) - placebo 100 mg saline subcutaneous injections daily for 4 days
Overall Study STARTED	2	3
Overall Study COMPLETED	2	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Acute Pericarditis With Anakinra

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Anakinra (3 Days) Then Anakinra (4 Days) n=2 Participants 100 mg subcutaneous injection Anakinra: Period 1 (Time 0-72 hours) - this will be an open-label phase during which all subjects meeting enrollment criteria will receive anakinra 100 mg subcutaneously injections daily for 3 days. Period 2 (Time 72 hours to 7 days) - anakinra 100 mg subcutaneous injections daily for 4 days	Anakinra (3 Days) Then Placebo (4 Days) n=3 Participants 100 mg NaCl 0.9% subcutaneous injection Placebo: Period 1 (Time 0-72 hours) - this will be an open-label phase during which all subjects meeting enrollment criteria will receive anakinra 100 mg subcutaneously injections daily for 3 days. Period 2 (Time 72 hours to 7 days) - placebo 100 mg saline subcutaneous injections daily for 4 days	Total n=5 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	3 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	42 years STANDARD_DEVIATION 9 • n=5 Participants	40 years STANDARD_DEVIATION 16 • n=7 Participants	41 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 6 hours

Outcome measures

Outcome measures
Measure	All Patients n=5 Participants This group includes all patients enrolled in the clinical trial
Pain Score	-3 units on a scale Interval -3.0 to -2.0

SECONDARY outcome

Timeframe: Baseline to 24 hours

Outcome measures

Outcome measures
Measure	All Patients n=5 Participants This group includes all patients enrolled in the clinical trial
Pain Score	-4 units on a scale Interval -4.25 to 4.0

Adverse Events

Anakinra (3 Days) Then Anakinra (4 Days)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Anakinra (3 Days) Then Placebo (4 Days)

Serious events: 3 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Anakinra (3 Days) Then Anakinra (4 Days) n=2 participants at risk Period 1 (Time 0-72 hours) - this will be an open-label phase during which all subjects meeting enrollment criteria will receive anakinra 100 mg subcutaneously injections daily for 3 days. Period 2 (Time 72 hours to 7 days) - anakinra 100 mg subcutaneous injections daily for 4 days	Anakinra (3 Days) Then Placebo (4 Days) n=3 participants at risk Period 1 (Time 0-72 hours) - this will be an open-label phase during which all subjects meeting enrollment criteria will receive anakinra 100 mg subcutaneously injections daily for 3 days. Period 2 (Time 72 hours to 7 days) - placebo 100 mg saline subcutaneous injections daily for 4 days
Vascular disorders Thrombophlebitis - After completion of anakinra	0.00% 0/2 • 30 days Adverse events assessed via daily physician examination and routine labs	33.3% 1/3 • Number of events 1 • 30 days Adverse events assessed via daily physician examination and routine labs
Cardiac disorders Coronary vasospasm - After completion of anakinra	0.00% 0/2 • 30 days Adverse events assessed via daily physician examination and routine labs	33.3% 1/3 • Number of events 1 • 30 days Adverse events assessed via daily physician examination and routine labs
Cardiac disorders Resistant pericarditis - After completion of anakinra	0.00% 0/2 • 30 days Adverse events assessed via daily physician examination and routine labs	33.3% 1/3 • Number of events 1 • 30 days Adverse events assessed via daily physician examination and routine labs

Other adverse events

Other adverse events
Measure	Anakinra (3 Days) Then Anakinra (4 Days) n=2 participants at risk Period 1 (Time 0-72 hours) - this will be an open-label phase during which all subjects meeting enrollment criteria will receive anakinra 100 mg subcutaneously injections daily for 3 days. Period 2 (Time 72 hours to 7 days) - anakinra 100 mg subcutaneous injections daily for 4 days	Anakinra (3 Days) Then Placebo (4 Days) n=3 participants at risk Period 1 (Time 0-72 hours) - this will be an open-label phase during which all subjects meeting enrollment criteria will receive anakinra 100 mg subcutaneously injections daily for 3 days. Period 2 (Time 72 hours to 7 days) - placebo 100 mg saline subcutaneous injections daily for 4 days
Skin and subcutaneous tissue disorders Injection site reactions - While taking anakinra	50.0% 1/2 • Number of events 1 • 30 days Adverse events assessed via daily physician examination and routine labs	33.3% 1/3 • Number of events 1 • 30 days Adverse events assessed via daily physician examination and routine labs

Additional Information

Antonio Abbate, MD, PhD

VCU Health

Phone: 804-828-0513

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place