drugset / Trial / NCT06071156
Therapy Management in Patients Treated With Anakinra Due to Recurrent Pericarditis
RandomizedParallel-groupOpen-labelPrevention
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.
Timeline
- Start
- 2018-01-01
- Primary completion
- 2022-05-05
- Completion
- 2025-01-31
Publications
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Anakinra | Protein / enzyme biologic | 2 mg/kg | — |
| Comparator | Anakinra | Protein / enzyme biologic | 100 mg | — |