Rilonacept for Recurrent Pericarditis

(RESONANCE Trial)

Not currently recruiting at 34 trial locations
AR
JC
Overseen ByJoAnn Clair, PhD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Kiniksa Pharmaceuticals International, plc
Must be taking: RP medications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on individuals with recurrent pericarditis (RP), a condition where the heart's lining becomes inflamed multiple times. The trial aims to understand RP's impact on daily life and health and to evaluate the effectiveness of rilonacept, an anti-inflammatory medication, in real-world settings. Eligible participants must have a doctor-confirmed diagnosis of RP and either currently experience symptoms or have been symptom-free for a while. Those currently affected should have had at least one RP episode in the past three years, while symptom-free individuals should have had no episodes for at least three years.

As a Phase 3 trial, this study represents the final step before FDA approval, allowing participants to contribute to validating a promising treatment.

What is the safety track record for rilonacept?

Studies have shown that rilonacept is safe for people with recurring heart inflammation, known as pericarditis. Research indicates that rilonacept quickly reduces pain and swelling and helps improve quality of life. The FDA has already approved this drug for treating recurrent pericarditis, confirming its safety for this use. Participants in studies who took rilonacept experienced fewer flare-ups than those who did not, suggesting it is generally well-tolerated.12345

Why are researchers excited about this trial?

Unlike other treatments for recurrent pericarditis, which often involve anti-inflammatory medications or corticosteroids, this trial focuses on understanding the natural history of the condition in both pediatric and adult patients. Researchers are excited about this trial because it aims to gather comprehensive data that can lead to better understanding and management of recurrent pericarditis. By studying the progression and characteristics of the condition in various age groups, this registry could pave the way for more personalized and effective treatment strategies in the future.

What evidence suggests that rilonacept might be an effective treatment for recurrent pericarditis?

Research has shown that rilonacept can help treat recurring pericarditis. In one study, rilonacept quickly eased pericarditis episodes and helped patients use fewer steroids. Another study found that this treatment reduced the chances of pericarditis returning. Patients experienced less pain, less swelling, and an improved quality of life. Overall, rilonacept has effectively reduced symptoms and prevented recurrences.56789

Who Is on the Research Team?

JF

John F Paolini, MD, PhD

Principal Investigator

Kiniksa Pharmaceuticals Corp

Are You a Good Fit for This Trial?

Inclusion Criteria

ACTIVE RP PATIENTS
Physician-confirmed (or confirmation in medical records) diagnosis of RP defined as an initial, acute, episode and at least one pericarditis recurrence after the initial acute episode
Experienced at least one pericarditis episode in the 3 years prior to inclusion
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observation

Participants are observed to document RP-related clinical, health-related quality of life, and economic burden, and to generate data on the impact of rilonacept

5 years

Follow-up

Participants are monitored for changes in clinical outcomes and adverse events

5 years

What Are the Treatments Tested in This Trial?

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kiniksa Pharmaceuticals International, plc

Lead Sponsor

Trials
3
Recruited
1,500+

Kiniksa Pharmaceuticals (UK), Ltd.

Industry Sponsor

Trials
3
Recruited
610+

Citations

Phase 3 Trial of Interleukin-1 Trap Rilonacept in Recurrent ...Rilonacept therapy also led to rapid resolution of pericarditis episodes and successful weaning from glucocorticoids. The trial results were consistent ...
Sustained Pericarditis Recurrence Risk Reduction With ...Rilonacept, a once‐weekly interleukin‐1 alpha and beta cytokine trap, reduced pericarditis recurrence in the phase 3 study, RHAPSODY.
Efficacy and safety of rilonacept for recurrent pericarditisRilonacept led to rapid and sustained improvement in pain, inflammation (CRP and pericarditis manifestations) and HRQOL.
ARCALYST (rilonacept) RHAPSODY Clinical Trial ResultsIn the RW period (primary efficacy end point)*: ARCALYST significantly reduced the risk of pericarditis recurrence. · 7% (2 of 30) of patients treated with ...
Expanding the Patient Pool for RilonaceptRecurrent pericarditis complicates 15%-30% of acute pericarditis cases despite initial anti-inflammatory treatment.
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/33229362/
Efficacy and safety of rilonacept for recurrent pericarditisRilonacept led to rapid and sustained improvement in pain, inflammation (CRP and pericarditis manifestations) and HRQOL.
What is Recurrent Pericarditis?ARCALYST® (rilonacept) is an interleukin-1 blocker indicated for: Treatment of Recurrent Pericarditis (RP) and reduction in risk of recurrence in adults and ...
Page 1 of 21 This label may not be the latest approved by FDA ...ARCALYST is indicated for the treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and pediatric patients 12 years and older.
RILONACEPT IN RECURRENT PERICARDITISThese data provide first evidence of rilonacept efficacy and safety in idiopathic RP. Updated data will be presented.
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