A Phase 2 interventional study of Anakinra and Placebo in Acute Pericarditis, sponsored by Virginia Commonwealth University. Terminated at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2021-02-23.
Sponsored by Virginia Commonwealth University · Phase 2, Interventional, and Treatment
The goal of this study is to determine the safety and efficacy of anakinra for the treatment of acute pericarditis when initiated within 6 hours of diagnosis and continued for 3 or 7 days.
Acute pericarditis is a clinical syndrome characterized by a profound inflammation of the membrane tissue that surrounds, supports and protects the heart. Acute pericarditis can be caused by a variety of infectious and non-infectious agents, but it most commonly either follows a viral infection of the upper respiratory tract or has no apparent cause.
Acute pericarditis occurs rather abruptly in previously healthy individuals, generally a child or young adult. Most cases of acute pericarditis resolve within a few days with non-steroidal anti-inflammatory drugs. However, patients experience severe chest pain and are at high risk for life-threatening complications involving the pericardium, such as pericardial tamponade. Acute pericarditis is diagnosed in 1 in 20 (5%) ED visits for chest pain.
Anakinra (Kineret) has been shown to treat and cure refractory and recurrent pericarditis. This study is aimed at determining whether anakinra is also effective as first line treatment in acute pericarditis.
54 studies on the registry are indexed under Pericarditis; 23 are open to participants now.
This study's enrollment of 5 is below the median of 60 across 29 interventional studies indexed under Pericarditis.
Browse Pericarditis studies →Virginia Commonwealth University is the lead sponsor of 648 studies on the registry; 80 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 64 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
100 mg subcutaneous injection
Drug: Anakinra
100 mg NaCl 0.9% subcutaneous injection
Drug: 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) - anakinra 100 mg subcutaneous injections daily for 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
Pain Score
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".
Time frame: Baseline to 6 hours
Pain Score
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".
Time frame: Baseline to 24 hours
| Milestone | Anakinra (3 Days) Then Anakinra (4 Days) | Anakinra (3 Days) Then Placebo (4 Days) |
|---|---|---|
| Started | 2 | 3 |
| Completed | 2 | 3 |
| Not completed | 0 | 0 |
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".
| units on a scale | All Patients |
|---|---|
| Pain Score | -3 (-3 to -2) |
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".
| units on a scale | All Patients |
|---|---|
| Pain Score | -4 (-4.25 to 4) |
Collected over 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Anakinra (3 Days) Then Anakinra (4 Days) | 0/2 (0%) | 0/2 (0%) | 1/2 (50%) |
| Anakinra (3 Days) Then Placebo (4 Days) | 0/3 (0%) | 3/3 (100%) | 1/3 (33.3%) |
| Event | Anakinra (3 Days) Then Anakinra (4 Days) | Anakinra (3 Days) Then Placebo (4 Days) |
|---|---|---|
| Thrombophlebitis - After completion of anakinraVascular disorders | 0/2 | 1/3 |
| Coronary vasospasm - After completion of anakinraCardiac disorders | 0/2 | 1/3 |
| Resistant pericarditis - After completion of anakinraCardiac disorders | 0/2 | 1/3 |
| Event | Anakinra (3 Days) Then Anakinra (4 Days) | Anakinra (3 Days) Then Placebo (4 Days) |
|---|---|---|
| Injection site reactions - While taking anakinraSkin and subcutaneous tissue disorders | 1/2 | 1/3 |
| Age, Categorical(Participants) | Anakinra (3 Days) Then Anakinra (4 Days) | Anakinra (3 Days) Then Placebo (4 Days) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 3 | 5 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Anakinra (3 Days) Then Anakinra (4 Days) | Anakinra (3 Days) Then Placebo (4 Days) | Total |
|---|---|---|---|
| Mean | 42 ± 9 | 40 ± 16 | 41 ± 12 |
| Sex: Female, Male(Participants) | Anakinra (3 Days) Then Anakinra (4 Days) | Anakinra (3 Days) Then Placebo (4 Days) | Total |
|---|---|---|---|
| Female | 1 | 0 | 1 |
| Male | 1 | 3 | 4 |
| Race (NIH/OMB)(Participants) | Anakinra (3 Days) Then Anakinra (4 Days) | Anakinra (3 Days) Then Placebo (4 Days) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 1 | 2 | 3 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Anakinra (3 Days) Then Anakinra (4 Days) | Anakinra (3 Days) Then Placebo (4 Days) | Total |
|---|---|---|---|
| United States | 2 | 3 | 5 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is terminated, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Interleukin 1 Receptor Antagonist Protein
Virginia Commonwealth University →