An interventional study of Anakinra in Recurrent Pericarditis, sponsored by Azienda Ospedaliero, Universitaria Ospedali Riuniti. Recruiting at 1 site in Italy. Per ClinicalTrials.gov, last updated 2024-04-16.
Sponsored by Azienda Ospedaliero, Universitaria Ospedali Riuniti · Not applicable, Interventional, and Prevention
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.
Recurrent pericarditis (RP) is a specific pathology of the pericardium included within the pericardial syndromes by the guidelines of the European Society of Cardiology (ESC). The latter defines RP as pericarditis occurring after a symptom-free interval of 4-6 weeks from a documented first episode of acute pericarditis; the recurrences rate may range from 15 to 30%, with a significant increment of 50% in patients treated with corticosteroids or not treated with colchicine. The diagnosis of recurrences follows the same criteria utilized for acute pericarditis, and a viral etiology can often be demonstrated.
The pathogenesis of RP is still debated, but they are self-sustained by an autoinflammatory/ autoimmune amplified response following an exogenous or endogenous trigger. In this context, the cytokine interleukin 1 (IL-1) has been implicated as a key mediator of RP. Anakinra, an IL-1 antagonist, is of particular interest because it limits the self-sustained pathway of RP and may reduce the recurrences. The current 2015 ESC guidelines for the diagnosis and management of pericardial diseases recommend anakinra in cases of proven infection-negative, corticosteroid-dependent RP not responsive to colchicine, but it remains debated the duration of the therapy and when to start its tapering. In this context, cardiac magnetic resonance (CMR) imaging has recently emerged as an interesting imaging biomarker capable of detecting pericardial inflammation, proving pericardial edema and late gadolinium enhancement (LGE), and distinguishing three defined pericardial inflammation phases: acute (edema and LGE), subacute (only LGE) and burned-out (no edema nor LGE).
To overcome the 2015 ESC guidelines limitations, the investigators sought to determine the utility of serial CMR imaging for guidance of therapy management in patients treated with anakinra due to RP, compared with the c-reactive protein (CRP) assay alone, as currently recommended.
54 studies on the registry are indexed under Pericarditis; 23 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 29 interventional studies indexed under Pericarditis.
Browse Pericarditis studies →Azienda Ospedaliero, Universitaria Ospedali Riuniti is the lead sponsor of 8 studies on the registry; 4 are open to participants now.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Anakinra, an IL-1 antagonist, is particularly interesting because it limits the self-sustained pathway of recurrent pericarditis and may reduce the recurrences
Recurrences of pericarditis
Recurrences of pericarditis during Anakinra reduction regimen of therapy
Time frame: 6 month
Plan to share: Undecided
Ran from Jan 2018 to primary completion in May 2022, 52 months.
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Studies of the drug tested here: Interleukin 1 Receptor Antagonist Protein
Azienda Ospedaliero, Universitaria Ospedali Riuniti