NCT03737110Phase 3Completed

Study to Assess the Efficacy and Safety of Rilonacept Treatment in Participants With Recurrent Pericarditis

Study sponsor: Kiniksa Pharmaceuticals (UK), Ltd.

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2020-05-29Actual

Enrollment · participants86Actual

Source updated2023-09-06Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Recurrent Pericarditis

Treatments or interventions studied

RilonaceptDrugAlso known as KPL-914, Arcalyst® for Cryopyrin-Associated Periodic Syndromes (CAPS)
PlaceboDrug

Primary outcomes · main study measures

Read the study measures

measure: Time to Pericarditis Recurrence in the RW Period; description: Time to pericarditis recurrence (from randomization to 1st recurrence). Kaplan-Meier. Clinical Events Committee (CEC)-confirmed recurrences used for primary analysis. Recurrence defined as recurrence typical pericarditis pain with supportive objective evidence. CEC-adjudicated recurrences defined as:1) Re-appearance/worsening pericarditis pain (1 NRS ≥ 4) AND elevated CRP (≥1.0 mg/dL) on same day/separated by ≤ 7 days OR 2) Re-appearance/worsening pericarditis pain (1 NRS ≥ 4) AND abnormal CRP (\> 0.5 mg/dL) on same day/separated by ≤ 7 days AND 1 supportive evidence OR 3) Re-appearance/worsening pericarditis pain (no NRS ≥ 4) AND elevated CRP (≥ 1.0 mg/dL) not attributable to other causes AND 1 supportive evidence. Supportive evidence: White blood cell count \> upper limit normal, fever \> 38C, pericardial rub, electrocardiogram changes consistent with pericarditis, new/worsening pericardial effusion (echocardiogram), new/worsening pericardial inflammation (magnetic resonance imaging).; timeFrame: RW Period (mean 24.8 weeks)

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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