Treatment of Acute Pericarditis With Anakinra

NCT03224585 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: HM20008638
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

1. 1.to determine the efficacy of anakinra with respect to chest pain resolution
2. 2.to determine the safety of anakinra with respect to adverse drug events

Conditions

Acute Pericarditis

Keywords

anakinra; Kineret; pericarditis

Outcome Measures

Primary Outcomes (1)

• 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".

  Baseline to 6 hours

Secondary Outcomes (1)

• Pain Score

  Baseline to 24 hours

Study Arms (2)

Anakinra

EXPERIMENTAL

100 mg subcutaneous injection

Drug: Anakinra

Placebo

PLACEBO COMPARATOR

100 mg NaCl 0.9% subcutaneous injection

Drug: Placebo

Interventions

Anakinra DRUG

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

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥12 years in presence of a parent able to provide consent or age \>18 years
• First or recurrent episode of acute pericarditis, defined as the presence of at least 2 of the following:
• Chest pain (suggestive of pericarditis and not explained by another condition)
• Pericardial friction rub on physical exam
• ST-segment elevation and/or PR depression on ECG
• New or worsening pericardial effusion
• Pain of moderate-to-severe intensity (pain score ≥6 on a scale of 0-10 where 0 is no pain at all and 10 is the worst pain ever experienced) at time on enrollment
• Ability to provide written informed consent if 18 years or older or to provide assent in presence of parental consent if 12-17 years of age

You may not qualify if:

• Pericarditis due to known bacterial or fungal infection
• Pericarditis due to known malignancy
• Pericarditis after cardiac surgery
• Tamponade or need for pericardiocentesis for diagnostic/therapeutic purposes
• Pregnancy or breastfeeding
• Hypersensitivity to anakinra, latex or products derived from Escherichia coli
• Chronic pain syndrome or chronic use of analgesic drugs

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

• Wohlford GF, Buckley LF, Vecchie A, Kadariya D, Markley R, Trankle CR, Chiabrando JG, de Chazal HM, Van Tassell B, Abbate A. Acute Effects of Interleukin-1 Blockade Using Anakinra in Patients With Acute Pericarditis. J Cardiovasc Pharmacol. 2020 Jul;76(1):50-52. doi: 10.1097/FJC.0000000000000847.

  PMID: 32398478 DERIVED

MeSH Terms

Conditions

Pericarditis

Interventions

Interleukin 1 Receptor Antagonist Protein

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Antonio Abbate, MD, PhD
• Organization: VCU Health

antonio.abbate@vcuhealth.org

804-828-0513

Study Officials

• Antonio Abbate, MD, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2017
• First Posted: July 21, 2017
• Study Start: May 11, 2018
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: February 23, 2021
• Results First Posted: February 23, 2021

Record last verified: 2021-02

Locations

US (1)