Therapy Management in Patients Treated With Anakinra Due to Recurrent Pericarditis

NCT06071156 | Recruiting

• 1 other identifier: CCPC- 003/18
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the utility of serial cardiac magnetic resonance (CMR) imaging for guidance of therapy management in patients treated with anakinra due to recurrent pericarditis (RP), compared with c-reactive protein (CRP) assay alone.

Conditions

Recurrent Pericarditis

Keywords

Anakinra; Cardiac magnetic resonance; Late gadolinium enhancement; C-reactive protein

Outcome Measures

Primary Outcomes (1)

• Recurrences of pericarditis

  Recurrences of pericarditis during Anakinra reduction regimen of therapy

  6 month

Study Arms (2)

CMR-guided therapy management,

ACTIVE COMPARATOR

The scheme of Anakinra treatment was three months at full dosage, the next three months of therapy at full dosage every other day, and the last three months at halved dosage every other day until the end of treatment. Cardiac magnetic resonance \[no pericardial edema and/or late gadolinium enchantment (LGE)\] guided each anakinra dose reduction. If the tests were positive for ongoing pericardial inflammation \[pericardial edema present or LGE present\], the reduction was postponed, and one more month of therapy was administered before the reduction.

Drug: Anakinra

CRP-guided therapy management,

ACTIVE COMPARATOR

The scheme of Anakinra treatment was three months at full dosage, the next three months of therapy at full dosage every other day, and the last three months at halved dosage every other day until the end of treatment. Laboratory tests \[C-reactive protein (CRP) \<0.6 mg/dL\] guided each anakinra dose reduction. If the tests were positive for ongoing systemic inflammation (CRP \> 0.6 mg/dL), the reduction was postponed, and one more month of therapy was administered before the reduction.

Drug: Anakinra

Interventions

Anakinra DRUG

Anakinra, an IL-1 antagonist, is particularly interesting because it limits the self-sustained pathway of recurrent pericarditis and may reduce the recurrences

CMR-guided therapy management,; CRP-guided therapy management,

Eligibility Criteria

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

You may qualify if:

• Adult patients treated with anakinra 100 mg/die if ≥ 18 years old, and
• Pediatric patients treated with anakinra 2 mg/kg/die if \< 18 years old
• Pediatric and adult patients treated with anakinra due to corticosteroid-dependent or not responsive to colchicine or non-steroidal anti-inflammatory drugs (NSAIDs) recurrent pericarditis

You may not qualify if:

• Ongoing infection (proved within serology)
• Refuse to participate in the trial

Sponsors & Collaborators

• Azienda Ospedaliero, Universitaria Ospedali Riuniti: lead

Study Sites (1)

CCPC

Ancona, The Marches, 60123, Italy

RECRUITING

Related Publications (6)

• Adler Y, Charron P, Imazio M, Badano L, Baron-Esquivias G, Bogaert J, Brucato A, Gueret P, Klingel K, Lionis C, Maisch B, Mayosi B, Pavie A, Ristic AD, Sabate Tenas M, Seferovic P, Swedberg K, Tomkowski W; ESC Scientific Document Group. 2015 ESC Guidelines for the diagnosis and management of pericardial diseases: The Task Force for the Diagnosis and Management of Pericardial Diseases of the European Society of Cardiology (ESC)Endorsed by: The European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2015 Nov 7;36(42):2921-2964. doi: 10.1093/eurheartj/ehv318. Epub 2015 Aug 29. No abstract available.

  PMID: 26320112 RESULT

• Imazio M, Andreis A, De Ferrari GM, Cremer PC, Mardigyan V, Maestroni S, Luis SA, Lopalco G, Emmi G, Lotan D, Marcolongo R, Lazaros G, De Biasio M, Cantarini L, Dagna L, Cercek AC, Pivetta E, Varma B, Berkson L, Tombetti E, Iannone F, Prisco D, Caforio ALP, Vassilopoulos D, Tousoulis D, De Luca G, Giustetto C, Rinaldi M, Oh JK, Klein AL, Brucato A, Adler Y. Anakinra for corticosteroid-dependent and colchicine-resistant pericarditis: The IRAP (International Registry of Anakinra for Pericarditis) study. Eur J Prev Cardiol. 2020 Jun;27(9):956-964. doi: 10.1177/2047487319879534. Epub 2019 Oct 15.

  PMID: 31610707 RESULT

• Cremer PC, Lin D, Luis SA, Petersen J, Abbate A, Jellis CL, Kwon D, Brucato A, Fang F, Insalaco A, LeWinter M, Lewis BS, Zou L, Nicholls SJ, Klein AL, Imazio M, Paolini JF; RHAPSODY Investigators. Pericardial late gadolinium enhancement and time to recurrence: a substudy from RHAPSODY, a phase 3 clinical trial of rilonacept in recurrent pericarditis. Eur Heart J Imaging Methods Pract. 2023 May 26;1(1):qyad003. doi: 10.1093/ehjimp/qyad003. eCollection 2023 May.

  PMID: 39044797 RESULT

• Conte E, Agalbato C, Melotti E, Marchetti D, Schillaci M, Ratti A, Ippolito S, Pancrazi M, Perone F, Dalla Cia A, Pepi M, Pontone G, Imazio M, Brucato A, Chetrit M, Klein A, Andreini D. The Contemporary Role of Cardiac Computed Tomography and Cardiac Magnetic Resonance Imaging in the Diagnosis and Management of Pericardial Diseases. Can J Cardiol. 2023 Aug;39(8):1111-1120. doi: 10.1016/j.cjca.2023.01.030. Epub 2023 Feb 3.

  PMID: 36740019 RESULT

• Kumar A, Sato K, Verma BR, Ala CK, Betancor J, Yzeiraj E, Lin L, Mohananey D, Qamruddin S, Kontzias A, Bolen MA, Imazio MM, Kwon DH, Hachamovitch R, Klein AL. Quantitative assessment of pericardial delayed hyperenhancement helps identify patients with ongoing recurrences of pericarditis. Open Heart. 2018 Dec 16;5(2):e000944. doi: 10.1136/openhrt-2018-000944. eCollection 2018.

  PMID: 30613419 RESULT

• Bianco F, Bucciarelli V, Coretti F, Cataldi S, Damadei F, Raffaelli E, Schicchi N, Omenetti A, Lattanzi B, Berton E, Chiara Surace F, Baldinelli A, Breda L, Cazzato S, Catassi C, Dello Russo A, Gallina S. Serial cardiac magnetic resonance imaging for guidance of therapy management in patients treated with anakinra due to recurrent pericarditis. Eur Heart J Imaging Methods Pract. 2024 Mar 28;2(1):qyae019. doi: 10.1093/ehjimp/qyae019. eCollection 2024 Jan.

  PMID: 39045200 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

Central Study Contacts

Francesco Bianco, M.D., Ph.D.

CONTACT

+390715965517; francesco.bianco@ospedaliriuniti.marche.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist

Model Details: 1:1 randomization

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 6, 2023
• Study Start: January 1, 2018
• Primary Completion: May 5, 2022
• Study Completion: January 31, 2025
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

IT (1)