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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03737110
Registration number
NCT03737110
Ethics application status
Date submitted
30/10/2018
Date registered
9/11/2018
Date last updated
6/09/2023
Titles & IDs
Public title
Study to Assess the Efficacy and Safety of Rilonacept Treatment in Participants With Recurrent Pericarditis
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Scientific title
Phase 3, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study With Open-label Extension, to Assess the Efficacy and Safety of Rilonacept Treatment in Subjects With Recurrent Pericarditis
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Secondary ID [1]
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2018-002719-87
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Secondary ID [2]
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KPL-914-C002
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Universal Trial Number (UTN)
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Trial acronym
RHAPSODY
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Recurrent Pericarditis
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Condition category
Condition code
Cardiovascular
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Other cardiovascular diseases
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Rilonacept
Treatment: Drugs - Placebo
Experimental: Rilonacept - RI period: single-blind rilonacept 320 mg (or 4.4 mg/kg in pediatric participants) SC, followed by 160 mg (or 2.2 mg/kg in pediatric participants) injections once weekly.
RW period: eligible participants randomized to double-blinded administration of rilonacept 160 mg (or 2.2 mg/kg in pediatric participants) SC injections once weekly. Participants with pericarditis recurrence who meet the protocol criteria for bailout rilonacept (report at least 1 day with pericarditis pain =4 on the 11-point NRS and have 1 CRP value = 1 mg/dL [either on the same day or separated by no more than 7 days]) receive bailout rilonacept (2 open-label injections of 160 mg rilonacept [or 4.4 mg/kg for pediatric participants]) irrespective of randomized treatment assignment and as soon as at least 5 days have passed since the last study drug injection.
LTE period: open-label administration of rilonacept 160 mg (or 2.2 mg/kg in pediatric participants) SC injections once weekly.
Placebo Comparator: Placebo - RI period: single-blind rilonacept 320 mg (or 4.4 mg/kg in pediatric participants) SC, followed by 160 mg (or 2.2 mg/kg in pediatric participants) injections once weekly.
RW period: eligible participants randomized to placebo SC injections once weekly. Participants with pericarditis recurrence who meet the protocol criteria for bailout rilonacept (report at least 1 day with pericarditis pain =4 on the 11-point NRS and have 1 CRP value = 1 mg/dL [either on the same day or separated by no more than 7 days]) receive bailout rilonacept (2 open-label injections of 160 mg rilonacept [or 4.4 mg/kg for pediatric participants]) irrespective of randomized treatment assignment and as soon as at least 5 days have passed since the last study drug injection.
LTE period: open-label administration of rilonacept 160 mg (or 2.2 mg/kg in pediatric participants) SC injections once weekly.
Treatment: Drugs: Rilonacept
Rilonacept 320 mg (or 4.4 mg/kg in pediatric participants =12 and <18 years old) SC , followed by 160 mg (or 2.2 mg/kg in pediatric participants =12 and <18 years old) injections once weekly
Treatment: Drugs: Placebo
Placebo SC injections once weekly
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to Pericarditis Recurrence in the RW Period
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Assessment method [1]
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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).
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Timepoint [1]
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RW Period (mean 24.8 weeks)
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Secondary outcome [1]
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Major Secondary Efficacy Endpoint: Percentage of Participants Who Maintained Clinical Response at Week 16 of the RW Period
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Assessment method [1]
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Participants were asked to select the score that best describes their average level of pericarditis pain over the previous 24 hours using an 11-point numerical rating scale (NRS), where zero (0) indicates 'no pain' and ten (10) indicates 'pain as bad as it could be'. Clinical response was defined as a weekly average of daily pericarditis pain on the NRS = 2.0 and C-reactive protein (CRP) level = 0.5 mg/dL, and on monotherapy of randomized study drug at Week 16.
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Timepoint [1]
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RW Period Week 16
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Secondary outcome [2]
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Major Secondary Efficacy Endpoint: Percentage of Days With No or Minimal Pericarditis Pain at Week 16 of the RW Period
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Assessment method [2]
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Participants were asked to select the score that best describes their average level of pericarditis pain over the previous 24 hours using an 11-point numerical rating scale (NRS), where zero (0) indicates 'no pain' and ten (10) indicates 'pain as bad as it could be'. No or minimal pain was defined as non-missing NRS = 2.
The percentage of days with no or minimal pericarditis pain in the first 16 weeks was calculated for each participant using 16×7 as the denominator. Missing values in pain diary were counted as 0 day with no or minimal pain. Days of using oral rescue therapy or corticosteroid count as 0 day with no or minimal pain. If bailout rilonacept was used, each administration (loading dose or not) was counted as 7 days without qualifying no or minimal pain.
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Timepoint [2]
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RW Period Week 16
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Secondary outcome [3]
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Major Secondary Efficacy Endpoint: Percentage of Participants With Absent or Minimal Pericarditis Symptoms Based on the Patient Global Impression of Pericarditis Severity (PGIPS) at Week 16 of the RW Period
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Assessment method [3]
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Percentage of participants with no or minimal pericarditis symptoms at Week 16, based on the PGIPS, a single-item measure of the participant's impression of the overall severity of pericarditis symptoms at the time the questionnaire is administered using a 7-point rating scale ranging from absent (0=no recurrent pericarditis symptoms) to very severe (6=recurrent pericarditis symptoms that cannot be ignored and markedly limits daily activities).
The exact 95% CI is calculated with randomization strata pooled. Participants who had received bailout rilonacept or rescue medication before the time point were considered nonresponders.
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Timepoint [3]
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RW Period Week 16
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Secondary outcome [4]
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Percentage of Participants Who Maintained Clinical Response at Week 24 of the RW Period
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Assessment method [4]
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Participants were asked to select the score that best describes their average level of pericarditis pain over the previous 24 hours using an 11-point numerical rating scale (NRS), where zero (0) indicates 'no pain' and ten (10) indicates 'pain as bad as it could be'. Clinical response was defined as a weekly average of daily pericarditis pain on the NRS = 2.0 and C-reactive protein (CRP) level = 0.5 mg/dL, and on monotherapy of randomized study drug at Week 24.
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Timepoint [4]
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RW Period Week 24
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Secondary outcome [5]
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Percentage of Participants Who Maintained Clinical Response at Week 8 of the RW Period
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Assessment method [5]
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Participants were asked to select the score that best describes their average level of pericarditis pain over the previous 24 hours using an 11-point numerical rating scale (NRS), where zero (0) indicates 'no pain' and ten (10) indicates 'pain as bad as it could be'. Clinical response was defined as a weekly average of daily pericarditis pain on the NRS = 2.0 and C-reactive protein (CRP) level = 0.5 mg/dL, and on monotherapy of randomized study drug at Week 8.
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Timepoint [5]
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RW Period Week 8
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Secondary outcome [6]
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Percentage of Days With No or Minimal Pericarditis Pain at Week 24 of the RW Period
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Assessment method [6]
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Participants were asked to select the score that best describes their average level of pericarditis pain over the previous 24 hours using an 11-point numerical rating scale (NRS), where zero (0) indicates 'no pain' and ten (10) indicates 'pain as bad as it could be'. No or minimal pain was defined as non-missing NRS = 2.
The percentage of days with no or minimal pericarditis pain in the first 24 weeks was calculated for each participant using 24×7 as the denominator. Missing values in pain diary were counted as 0 day with no or minimal pain. Days of using oral rescue therapy or corticosteroid count as 0 day with no or minimal pain. If bailout rilonacept was used, each administration (loading dose or not) was counted as 7 days without qualifying no or minimal pain.
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Timepoint [6]
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RW Period Week 24
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Secondary outcome [7]
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Percentage of Days With No or Minimal Pericarditis Pain at Week 8 of the RW Period
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Assessment method [7]
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Participants were asked to select the score that best describes their average level of pericarditis pain over the previous 24 hours using an 11-point numerical rating scale (NRS), where zero (0) indicates 'no pain' and ten (10) indicates 'pain as bad as it could be'. No or minimal pain was defined as non-missing NRS = 2.
The percentage of days with no or minimal pericarditis pain in the first 24 weeks was calculated for each participant using 8×7 as the denominator. Missing values in pain diary were counted as 0 day with no or minimal pain. Days of using oral rescue therapy or corticosteroid count as 0 day with no or minimal pain. If bailout rilonacept was used, each administration (loading dose or not) was counted as 7 days without qualifying no or minimal pain.
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Timepoint [7]
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RW Period Week 8
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Secondary outcome [8]
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Percentage of Participants With Absent or Minimal Pericarditis Symptoms at Week 24 of the RW Period Based on the PGIPS
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Assessment method [8]
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Percentage of participants with no or minimal pericarditis symptoms at Week 24, based on the PGIPS, a single-item measure of the participant's impression of the overall severity of pericarditis symptoms at the time the questionnaire is administered using a 7-point rating scale ranging from absent (0=no recurrent pericarditis symptoms) to very severe (6=recurrent pericarditis symptoms cannot be ignored and markedly limits daily activities).
The exact 95% CI is calculated with randomization strata pooled. Participants who had received bailout rilonacept or rescue medication before the time point were considered nonresponders.
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Timepoint [8]
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RW Period Week 24
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Secondary outcome [9]
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Percentage of Participants With Absent or Minimal Pericarditis Symptoms at Week 8 of the RW Period Based on the PGIPS
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Assessment method [9]
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Percentage of participants with no or minimal pericarditis symptoms at Week 16, based on the Patient Global Impression of Pericarditis Severity (PGI-PS). The PGI-PS is a single-item measure of the participant's impression of the overall severity of pericarditis symptoms at the time the questionnaire is administered, using a 7-point rating scale ranging from absent (no recurrent pericarditis symptoms) to very severe (recurrent pericarditis symptoms cannot be ignored).
The exact 95% CI is calculated with randomization strata pooled. Participants who had received bailout rilonacept or rescue medication before the time point were considered nonresponders.
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Timepoint [9]
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RW Period Week 8
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Secondary outcome [10]
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Percentage of Participants Without Pericarditis Recurrence in the First 24 Weeks of the RW Period
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Assessment method [10]
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Pericarditis recurrence is defined as the recurrence of typical pericarditis pain associated with supportive objective evidence of pericarditis. At any time during the RW period, participants who experienced a suspected recurrence of pericarditis symptoms reported to the study site/clinic for a scheduled or unscheduled visit, during which clinical assessments were performed to gather all the necessary diagnostic data to confirm or rule out the presence of pericarditis recurrence. A pericarditis recurrence event adjudication package was then prepared for adjudication by CEC. Kaplan-Meier estimate.
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Timepoint [10]
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up to 24 weeks in the RW Period
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Secondary outcome [11]
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Time to Pericarditis Pain = 4 on the NRS in the RW Period
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Assessment method [11]
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Participants were asked to select the score that best described their average level of pericarditis pain over the previous 24 hours using an 11-point numerical rating scale (NRS), where zero (0) indicates 'no pain' and ten (10) indicates 'pain as bad as it could be'.
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Timepoint [11]
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RW Period (mean 24.8 weeks)
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Secondary outcome [12]
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Time to CRP Level = 1 mg/dL in the RW Period
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Assessment method [12]
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Kaplan-Meier estimate.
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Timepoint [12]
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RW Period (mean 24.8 weeks)
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Secondary outcome [13]
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Time to Pericardial Rub in the RW Period
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Assessment method [13]
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Kaplan-Meier estimate. A pericardial rub (also called a pericardial friction rub) is an audible medical sign used in the diagnosis of pericarditis.
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Timepoint [13]
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RW Period (mean 24.8 weeks)
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Secondary outcome [14]
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Time to Widespread ST-segment Elevation or PR-segment Depression on Electrocardiogram (ECG) in the RW Period
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Assessment method [14]
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Kaplan-Meier estimate. ST-segment elevation and PR-segment depression are ECG changes in the evolution of acute pericarditis.
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Timepoint [14]
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RW Period (mean 24.8 weeks)
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Secondary outcome [15]
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Time to New or Worsening Pericardial Effusion on Echocardiography (ECHO) in the RW Period
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Assessment method [15]
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Pericardial effusion based on ECHO was evaluated by the central laboratory during the RW period. Kaplan-Meier estimate.
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Timepoint [15]
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RW Period (mean 24.8 weeks)
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Secondary outcome [16]
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Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period
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Assessment method [16]
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Pericardial effusion based on ECHO was evaluated by the central laboratory during the RW period. "None or trivial/physiologic" is considered to be normal. The "RW Worst Post-baseline" category denotes the largest size of pericardial effusion category in which a participant was reported at any time during the RW period (post-baseline).
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Timepoint [16]
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RW Period Baseline, RW Period Week 24, RW Period (mean 24.8 weeks)
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Secondary outcome [17]
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Change From RW Period Baseline Over Time in CRP Levels in RW Period
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Assessment method [17]
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Estimated from ANCOVA models including treatment arm as fix effect, baseline value, baseline value by treatment interaction, randomization strata as covariates.
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Timepoint [17]
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RW Period Baseline, RW Period Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 56
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Secondary outcome [18]
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Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period
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Assessment method [18]
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Participants were asked to select the score that best described their average level of pericarditis pain over the previous 24 hours using an 11-point numerical rating scale (NRS), where zero (0) indicates 'no pain' and ten (10) indicates 'pain as bad as it could be'. Estimated from ANCOVA models including treatment arm as fix effect, baseline value, baseline value by treatment interaction, randomization strata as covariates.
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Timepoint [18]
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RW Period Baseline, RW Period Weeks 1-50, 54
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Secondary outcome [19]
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Percentage of Participants With Absent or Minimal Pericarditis Symptoms Over Time After RW Period Week 24 Based on the PGIPS
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Assessment method [19]
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The PGIPS, a single-item measure of the participant's impression of the overall severity of pericarditis symptoms at the time the questionnaire is administered using a 7-point rating scale ranging from absent (0=no recurrent pericarditis symptoms) to very severe (6=recurrent pericarditis symptoms cannot be ignored and markedly limits daily activities).
The exact 95% CI is calculated with randomization strata pooled. Participants who had received bailout rilonacept or rescue medication before the time point were considered nonresponders.
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Timepoint [19]
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RW Period Weeks 32, 40, 48, 56
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Secondary outcome [20]
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Percentage of Participants With Absent or Minimal Pericarditis Activity Over Time in the RW Period Based on the Physician Global Assessment of Pericarditis Activity (PGA-PA)
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Assessment method [20]
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The PGA-PA is a single-item, clinician-reported outcome measure that Investigators use to rate their impression of the patient's overall pericarditis disease activity at the time the assessment is completed, using a rating scale ranging from absent to very severe. The Investigator selected the box that best described a participant's pericarditis activity at the time of occurrence of the assessment: Absent, Minimal, Mild, Moderate, Moderately Severe, Severe, Very Severe.
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Timepoint [20]
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RW Period Baseline, RW Period Weeks 8, 16, 24, 32, 40, 48, 56
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Secondary outcome [21]
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Change From RW Period Baseline in Short Form-36 (SF-36) Physical and Mental Component Scores at RW Period Week 24
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Assessment method [21]
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The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary (PCS) score of the SF-36. Items 5-8 primarily contribute to the mental component summary (MCS) score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best) with higher scores indicating better health. Increases from baseline indicate improvement.
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Timepoint [21]
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RW Period Baseline, RW Period Week 24
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Secondary outcome [22]
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Change From RW Baseline in SF-36 Individual Scores at RW Period Week 24
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Assessment method [22]
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The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scores on each item are summed and averaged (range: 0=worst to 100=best) with higher scores indicating better health. Increases from baseline indicate improvement.
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Timepoint [22]
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RW Period Baseline, RW Period Week 24
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Secondary outcome [23]
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Change From RW Period Baseline in the Short Form Health Survey-6 Domains (SF-6D) Utility Index Score at RW Period Week 24
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Assessment method [23]
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The SF-6D is calculated based on responses to 11 items on the SF-36, that correspond to 6 domains: physical functioning, role participation (combined role-physical and role-emotional), social functioning, bodily pain, mental health, and vitality. Individual respondents can be classified on any of 4 to 6 levels of functioning or limitations for each of 6 domains, thus allowing a respondent to be classified into any of 18,000 possible unique health states. Using a standard gamble technique, each of these health states were mapped onto the SF-6D index score, which ranges from 0.00 (worst possible health state/death) to 1.00 (best possible health state/perfect health).
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Timepoint [23]
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RW Period Baseline, RW Period Week 24
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Secondary outcome [24]
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Change From RW Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value to RW Period Week 24
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Assessment method [24]
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The EQ-5D-5L is a self-reported health status questionnaire that consists of 6 questions used to calculate a health utility score for use in health economic analysis. There are 2 components to the EQ-5D-5L: a 5-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a visual analogue scale (VAS) that measures health state. Individual and index scores range from 0 to 1, with low scores representing a higher level of dysfunction. The VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
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Timepoint [24]
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RW Period Baseline, RW Period Week 24
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Secondary outcome [25]
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Change From RW Period Baseline in Insomnia Severity Index (ISI) Total Score at RW Period Week 24
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Assessment method [25]
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Participant's sleep quality was assessed with the ISI survey questionnaire. The ISI is a 7-item survey, with each question having 5 possible answers (none, mild, moderate, severe, or very severe), scored as 0, 1, 2, 3, or 4, respectively. Scores are summed for a total score, which ranges from 0 to 28. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater insomnia.
Clinical interpretation of the total score is as follows:
0 to 7 = no clinically significant insomnia; 8 to 14 = subthreshold insomnia; 15 to 21 = clinical insomnia (moderate severity); 22 to 28 = clinical insomnia (severe).
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Timepoint [25]
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RW Period Baseline, RW Period Week 24
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Secondary outcome [26]
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Change in ISI Categories From RW Period Baseline to RW Period Week 24
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Assessment method [26]
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Participant's sleep quality was assessed with the ISI survey questionnaire. The ISI is a 7-item survey, with each question having 5 possible answers (none, mild, moderate, severe, or very severe), scored as 0, 1, 2, 3, or 4, respectively. Scores are summed for a total score, which ranges from 0 to 28. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater insomnia.
Clinical interpretation of the total score is as follows:
0 to 7 = no clinically significant insomnia; 8 to 14 = subthreshold insomnia; 15 to 21 = clinical insomnia (moderate severity); 22 to 28 = clinical insomnia (severe).
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Timepoint [26]
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RW Period Baseline (BL), RW Period Week (Wk) 24
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Secondary outcome [27]
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Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period
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Assessment method [27]
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ORT included analgesics, NSAIDs, and/or colchicine. ORT use while waiting for at least 5 days since previous administration of study drug before receiving bailout, or within 5 days before the assessment of pericarditis recurrence, was excluded.
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Timepoint [27]
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0
RW Period (mean 24.8 weeks)
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Secondary outcome [28]
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Percentage of Participants Using ORT for Pericarditis in the First 24 Weeks of RW Period
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Assessment method [28]
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ORT included analgesics, NSAIDs, and/or colchicine.
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Timepoint [28]
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0
RW Period (up to Week 24)
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Secondary outcome [29]
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Percentage of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion on Magnetic Resonance Imaging (MRI) at RW Week 24
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Assessment method [29]
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MRI assessments were performed in a subgroup of participants (MRI substudy) to assess the percentage of participants with:
Pericardial delayed hyperenhancement
Myocardial delayed hyperenhancement
Pericardial effusion
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Timepoint [29]
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0
RW Period Week 24
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Secondary outcome [30]
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0
Time From First Dose to Pain Response in the RI Period
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Assessment method [30]
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Participants were asked to select the score that best described their average level of pericarditis pain over the previous 24 hours using an 11-point numerical rating scale (NRS), where zero (0) indicates 'no pain' and ten (10) indicates 'pain as bad as it could be'. Time to pain response was defined as number of days from first dose to the first day a participant's daily pain NRS was = 2 of the 3 days over which the rolling average daily pain NRS was = 2.
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Timepoint [30]
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0
RI Period (up to 12 weeks)
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Secondary outcome [31]
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Time From First Dose to CRP Normalization in the RI Period
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Assessment method [31]
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Time to CRP normalization, defined as CRP = 0.5 mg/dL, was censored at treatment discontinuation, taking prohibited medication, or Week 12, whichever occurred first.
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Timepoint [31]
0
0
RI Period (up to 12 weeks)
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Secondary outcome [32]
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0
Time From First Dose to Rilonacept Monotherapy in RI Period
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Assessment method [32]
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Time to rilonacept monotherapy was defined as the number of weeks from first dose to the first day of achieving monotherapy.
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Timepoint [32]
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0
RI Period (up to 12 weeks)
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Secondary outcome [33]
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Time From First Dose to Treatment Response in RI Period
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Assessment method [33]
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Time to treatment response is defined as time from first dose to the first day of pain response, and CRP = 0.5 mg/dL within 7 days before or after pain response. Treatment response day will be the first day that the above criterion is met. If pain response occurs before CRP = 0.5 mg/dL, each 3-day rolling average of NRS should be = 2.0 from the day of pain response to the day of CRP = 0.5 mg/dL. The response day will be the day of pain response. If CRP =0.5 mg/dL occurs before pain response, the response day will also be the day of pain response.
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Timepoint [33]
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0
RI Period (up to 12 weeks)
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Secondary outcome [34]
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Percentage of Participants Achieving Clinical Response at RI Period Week 12
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Assessment method [34]
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Participants were asked to select the score that best described their average level of pericarditis pain over the previous 24 hours using an 11-point numerical rating scale (NRS), where zero (0) indicates 'no pain' and ten (10) indicates 'pain as bad as it could be'. Clinical Response was defined as a weekly average of daily pericarditis pain of = 2.0 on the 11-point NRS and CRP level = 0.5 mg/dL and participants must have been able to stop background SOC pericarditis therapy by Week 10.
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Timepoint [34]
0
0
RI Period Week 12
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Secondary outcome [35]
0
0
Percentage of Participants With CRP Normalization at RI Period Week 12
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Assessment method [35]
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0
CRP normalization was defined as CRP = 0.5 mg/dL.
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Timepoint [35]
0
0
RI Period Week 12
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Secondary outcome [36]
0
0
Change From Baseline Over Time in Weekly Average of Pericarditis Pain NRS Score in RI Period
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Assessment method [36]
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0
Participants were asked to select the score that best described their average level of pericarditis pain over the previous 24 hours using an 11-point numerical rating scale (NRS), where zero (0) indicates 'no pain' and ten (10) indicates 'pain as bad as it could be'.
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Timepoint [36]
0
0
RI Period Baseline, RI Period Weeks 1-12
Query!
Secondary outcome [37]
0
0
Change From Baseline Over Time in CRP Levels in RI Period
Query!
Assessment method [37]
0
0
Query!
Timepoint [37]
0
0
RI Period Baseline, RI Period Day 4, Weeks 1, 2, 4, 6, 12
Query!
Secondary outcome [38]
0
0
Percentage of Participants With Resolution of Pericarditis-Related ECHO and ECG Abnormalities at Week 12 of the RI Period
Query!
Assessment method [38]
0
0
Query!
Timepoint [38]
0
0
RI Period Baseline, RI Period Week 12
Query!
Secondary outcome [39]
0
0
Percentage of Days With No or Minimal Pain in the RI Period While on Treatment
Query!
Assessment method [39]
0
0
No or minimal pain is defined as non-missing daily NRS = 2, where participants were asked to select the score that best describes their average level of pericarditis pain over the previous 24 hours using an 11-point NRS, where zero (0) indicates 'no pain' and ten (10) indicates 'pain as bad as it could be'.
Query!
Timepoint [39]
0
0
RI Period (up to Week 12)
Query!
Secondary outcome [40]
0
0
Percentage of Participants With No or Minimal Pericarditis Symptoms Over Time in the RI Period, Based on the PGIPS
Query!
Assessment method [40]
0
0
The PGIPS, a single-item measure of the participant's impression of the overall severity of pericarditis symptoms at the time the questionnaire is administered using a 7-point rating scale ranging from absent (0=no recurrent pericarditis symptoms) to very severe (6=recurrent pericarditis symptoms cannot be ignored and markedly limits daily activities).
The exact 95% CI is calculated with randomization strata pooled. Participants who had received bailout rilonacept or rescue medication before the time point were considered nonresponders.
Query!
Timepoint [40]
0
0
RI Period Baseline, RI Period Weeks 6 and 12
Query!
Secondary outcome [41]
0
0
Percentage of Participants With No or Minimal Pericarditis Activity Over Time in the RI Period, Based on the PGA-PA
Query!
Assessment method [41]
0
0
The PGA-PA is a single-item, clinician-reported outcome measure that Investigators use to rate their impression of the patient's overall pericarditis disease activity at the time the assessment is completed, using a rating scale ranging from absent to very severe. The Investigator selected the box that best described a participant's pericarditis activity at the time of occurrence of the assessment: Absent, Minimal, Mild, Moderate, Moderately Severe, Severe, Very Severe.
The exact 95% CI is calculated with randomization strata pooled. Participants who had received bailout rilonacept or rescue medication before the time point were considered nonresponders.
Query!
Timepoint [41]
0
0
RI Period Baseline, RI Period Weeks 6 and 12
Query!
Secondary outcome [42]
0
0
Change From RI Period Baseline in the SF-36 Domain Scores and Physical and Mental Scores to RI Period Week 12
Query!
Assessment method [42]
0
0
The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scores on each item are summed and averaged (range: 0=worst to 100=best) with higher scores indicating better health. Increases from baseline indicate improvement.
Query!
Timepoint [42]
0
0
RI Period Baseline, RI Period Week 12
Query!
Secondary outcome [43]
0
0
Change From RI Period Baseline in SF-6D Scores at RI Period Week 12
Query!
Assessment method [43]
0
0
The SF-6D is calculated based on responses to 11 items on the SF-36, that correspond to 6 domains: physical functioning, role participation (combined role-physical and role-emotional), social functioning, bodily pain, mental health, and vitality. Individual respondents can be classified on any of 4 to 6 levels of functioning or limitations for each of 6 domains, thus allowing a respondent to be classified into any of 18,000 possible unique health states. Using a standard gamble technique, each of these health states were mapped onto the SF-6D index score, which ranges from 0.00 (worst possible health state/death) to 1.00 (best possible health state/perfect health).
Query!
Timepoint [43]
0
0
RI Period Baseline, RI Period Week 12
Query!
Secondary outcome [44]
0
0
Change From RI Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value at RI Period Week 12
Query!
Assessment method [44]
0
0
The EQ-5D-5L is a self-reported health status questionnaire that consists of 6 questions used to calculate a health utility score for use in health economic analysis. There are 2 components to the EQ-5D-5L: a 5-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a visual analogue scale (VAS) that measures health state. Individual and index scores range from 0 to 1, with low scores representing a higher level of dysfunction. The VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
Query!
Timepoint [44]
0
0
RI Period Baseline, RI Period Week 12
Query!
Secondary outcome [45]
0
0
Change From RI Period Baseline in ISI Total Score at RI Period Week 12
Query!
Assessment method [45]
0
0
Participant's sleep quality was assessed with the ISI survey questionnaire. The ISI is a 7-item survey, with each question having 5 possible answers (none, mild, moderate, severe, or very severe), scored as 0, 1, 2, 3, or 4, respectively. Scores are summed for a total score, which ranges from 0 to 28. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater insomnia.
Clinical interpretation of the total score is as follows:
0 to 7 = no clinically significant insomnia; 8 to 14 = subthreshold insomnia; 15 to 21 = clinical insomnia (moderate severity); 22 to 28 = clinical insomnia (severe).
Query!
Timepoint [45]
0
0
RI Period Baseline, RI Period Week 12
Query!
Secondary outcome [46]
0
0
Change in ISI Categories From RI Period Baseline to RI Period Week 12
Query!
Assessment method [46]
0
0
Participant's sleep quality was assessed with the ISI survey questionnaire. The ISI is a 7-item survey, with each question having 5 possible answers (none, mild, moderate, severe, or very severe), scored as 0, 1, 2, 3, or 4, respectively. Scores are summed for a total score, which ranges from 0 to 28. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater insomnia.
Clinical interpretation of the total score is as follows:
0 to 7 = no clinically significant insomnia; 8 to 14 = subthreshold insomnia; 15 to 21 = clinical insomnia (moderate severity); 22 to 28 = clinical insomnia (severe).
Query!
Timepoint [46]
0
0
RI Period Baseline (BL), RI Period Week (Wk) 12
Query!
Secondary outcome [47]
0
0
Number of Participants Who Were Off Background Pericarditis Medication on or Before RI Period Weeks 4, 8, 10, and 12
Query!
Assessment method [47]
0
0
Query!
Timepoint [47]
0
0
RI Period Baseline, RI Period Weeks 4, 8, 10, 12
Query!
Secondary outcome [48]
0
0
Annualized Rate of Pericarditis Recurrence in the Long-Term Extension (LTE) Period Based on Investigator's Assessment (Based on Investigators' Judgement)
Query!
Assessment method [48]
0
0
Annualized Recurrence Rate is defined as the number of recurrences in LTE periods for all participants/Sum of participant years in LTE periods for all participants. Participant years in LTE period is defined as the time from 1st dose date of LTE period to the date of End of Study, or data cutoff date, whichever is earlier. The 95% CI was calculated using an exact method with Poisson distribution. Pericarditis recurrence is defined as the recurrence of typical pericarditis pain associated with supportive objective evidence of pericarditis.
Query!
Timepoint [48]
0
0
LTE Period, through LTE Follow up (up to Week 48)
Query!
Secondary outcome [49]
0
0
Change From LTE Baseline Over Time in CRP Levels
Query!
Assessment method [49]
0
0
Query!
Timepoint [49]
0
0
LTE Baseline, LTE Week 12, LTE Week 24
Query!
Secondary outcome [50]
0
0
Percentage of Participants With Absent or Minimal Pericarditis Activity In the LTE Period Based on the PGIPS
Query!
Assessment method [50]
0
0
Percentage of participants with no or minimal pericarditis symptoms in the LTE Period, based on the PGIPS, a single-item measure of the participant's impression of the overall severity of pericarditis symptoms at the time the questionnaire is administered using a 7-point rating scale ranging from absent (0=no recurrent pericarditis symptoms) to very severe (6=recurrent pericarditis symptoms that cannot be ignored and markedly limits daily activities).
Query!
Timepoint [50]
0
0
LTE Baseline, LTE Month 12, LTE Month 24
Query!
Secondary outcome [51]
0
0
Percentage of Participants With Absent or Minimal Pericarditis Activity Over Time in the LTE Period Based on the PGA-PA
Query!
Assessment method [51]
0
0
The PGA-PA is a single-item, clinician-reported outcome measure that Investigators use to rate their impression of the patient's overall pericarditis disease activity at the time the assessment is completed, using a rating scale ranging from absent to very severe. The Investigator selected the box that best described a participant's pericarditis activity at the time of occurrence of the assessment: Absent, Minimal, Mild, Moderate, Moderately Severe, Severe, Very Severe.
Query!
Timepoint [51]
0
0
LTE Baseline, LTE Week 12, LTE Week 24
Query!
Secondary outcome [52]
0
0
Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores
Query!
Assessment method [52]
0
0
The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scores on each item are summed and averaged (range: 0=worst to 100=best) with higher scores indicating better health. Increases from baseline indicate improvement.
Query!
Timepoint [52]
0
0
LTE Baseline, LTE Week 24
Query!
Secondary outcome [53]
0
0
Change From LTE Baseline in SF-6D Health Utility Index Score
Query!
Assessment method [53]
0
0
The SF-6D is calculated based on responses to 11 items on the SF-36, that correspond to 6 domains: physical functioning, role participation (combined role-physical and role-emotional), social functioning, bodily pain, mental health, and vitality. Individual respondents can be classified on any of 4 to 6 levels of functioning or limitations for each of six domains, thus allowing a respondent to be classified into any of 18,000 possible unique health states. Using a standard gamble technique, each of these health states were mapped onto the SF-6D index score, which ranges from 0.00 (worst possible health state/death) to 1.00 (best possible health state/perfect health).
Query!
Timepoint [53]
0
0
LTE Baseline, LTE Week 24
Query!
Secondary outcome [54]
0
0
Change From LTE Baseline in EQ-5D-5L Individual Scores and Index Value
Query!
Assessment method [54]
0
0
The EQ-5D-5L is a self-reported health status questionnaire that consists of 6 questions used to calculate a health utility score for use in health economic analysis. There are 2 components to the EQ-5D-5L: a 5-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a visual analogue scale (VAS) that measures health state. Individual and index scores range from 0 to 1, with low scores representing a higher level of dysfunction. The VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
Query!
Timepoint [54]
0
0
LTE Baseline, LTE Week 24
Query!
Secondary outcome [55]
0
0
Change From LTE Baseline in ISI Total Score
Query!
Assessment method [55]
0
0
Participant's sleep quality was assessed with the ISI survey questionnaire. The ISI is a 7-item survey, with each question having 5 possible answers (none, mild, moderate, severe, or very severe), scored as 0, 1, 2, 3, or 4, respectively. Scores are summed for a total score, which ranges from 0 to 28. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater insomnia.
Clinical interpretation of the total score is as follows:
0 to 7 = no clinically significant insomnia; 8 to 14 = subthreshold insomnia; 15 to 21 = clinical insomnia (moderate severity); 22 to 28 = clinical insomnia (severe).
Query!
Timepoint [55]
0
0
LTE Baseline, LTE Week 24
Query!
Secondary outcome [56]
0
0
Change From LTE Baseline in ISI Categories
Query!
Assessment method [56]
0
0
Participant's sleep quality was assessed with the ISI survey questionnaire. The ISI is a 7-item survey, with each question having 5 possible answers (none, mild, moderate, severe, or very severe), scored as 0, 1, 2, 3, or 4, respectively. Scores are summed for a total score, which ranges from 0 to 28. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater insomnia.
Clinical interpretation of the total score is as follows:
0 to 7 = no clinically significant insomnia; 8 to 14 = subthreshold insomnia; 15 to 21 = clinical insomnia (moderate severity); 22 to 28 = clinical insomnia (severe).
Query!
Timepoint [56]
0
0
LTE Baseline (BL), LTE Week 24
Query!
Secondary outcome [57]
0
0
Percentage of Participants Requiring Addition of Standard of Care (SOC) Pericarditis Therapy Every 4 Weeks Cumulatively in the LTE Period
Query!
Assessment method [57]
0
0
Query!
Timepoint [57]
0
0
LTE Period, through LTE Follow up (up to Week 24)
Query!
Secondary outcome [58]
0
0
Change From LTE Baseline in Pericardial Signs in ECHO
Query!
Assessment method [58]
0
0
Query!
Timepoint [58]
0
0
LTE Baseline, LTE Week 24
Query!
Secondary outcome [59]
0
0
Change From LTE Baseline in Pericardial Signs in ECG
Query!
Assessment method [59]
0
0
Query!
Timepoint [59]
0
0
LTE Baseline, LTE Week 24
Query!
Secondary outcome [60]
0
0
Change From LTE Baseline in Pericardial Signs in MRI
Query!
Assessment method [60]
0
0
Query!
Timepoint [60]
0
0
LTE Baseline, LTE Week 24
Query!
Secondary outcome [61]
0
0
Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24
Query!
Assessment method [61]
0
0
Query!
Timepoint [61]
0
0
LTE Week 24
Query!
Secondary outcome [62]
0
0
Annualized Rate of Pericarditis Recurrence in LTE Periods Based on Investigator's Assessment
Query!
Assessment method [62]
0
0
Annualized Recurrence Rate is defined as number of recurrences in LTE periods for all participants/Sum of participant years in LTE period for all participants. Participant years in LTE period is defined as the time from 1st dose date of LTE period to the date of End of Study, or data cutoff date, whichever is earlier. The 95% CI was calculated using an exact method with Poisson distribution.
Pericarditis recurrence was defined as the recurrence of typical pericarditis pain associated with supportive objective evidence of pericarditis. At any time during the RW period, participants who experienced a suspected recurrence of pericarditis symptoms reported to the study site/clinic for a scheduled or unscheduled visit, during which clinical assessments were performed to gather all the necessary diagnostic data to confirm or rule out the presence of pericarditis recurrence.
Query!
Timepoint [62]
0
0
LTE Period, through LTE Follow up (up to Week 48)
Query!
Secondary outcome [63]
0
0
Annualized Rate of Pericarditis Recurrence in RW Period Based on CEC Adjudication
Query!
Assessment method [63]
0
0
Annualized Recurrence Rate is defined as the number of recurrences in RW period for all participants/Sum of participant years in RW period for all participants. Participant years in RW period is defined as the time from randomization date to the date of EORW or last dose date + 6 weeks, whichever is earlier. The 95% CI was calculated using an exact method with Poisson distribution.
Pericarditis recurrence was defined as the recurrence of typical pericarditis pain associated with supportive objective evidence of pericarditis. At any time during the RW period, participants who experienced a suspected recurrence of pericarditis symptoms reported to the study site/clinic for a scheduled or unscheduled visit, during which clinical assessments were performed to gather all the necessary diagnostic data to confirm or rule out the presence of pericarditis recurrence.
Query!
Timepoint [63]
0
0
RW Period (mean 24.8 weeks)
Query!
Eligibility
Key inclusion criteria
Key
1. Male or female aged 12 or older
2. Has a diagnosis of recurrent pericarditis
3. Must provide Informed Consent
4. Presents with at least the third episode of pericarditis during screening.
5. Has received nonsteroidal anti-inflammatory drugs (NSAIDs) and/or colchicine and/or
corticosteroids (in any combination), if used, at stable dose levels (or at least not
increased) for at least 3 days prior to first study drug administration
6. Female subjects must be postmenopausal, or incapable of pregnancy or permanently
sterile, or if of childbearing potential must agree to use highly-effective method of
contraception.
7. Must be up-to-date with all immunizations, in agreement with current local
immunization guidelines for immunosuppressed subjects, before first study drug
administration.
8. Is able to adequately maintain a daily subject diary according to protocol.
9. Agrees to refrain from making any new, major lifestyle changes that may affect
pericarditis symptoms (e.g., changing exercise pattern) from the time that the
informed consent form (ICF) is signed through the end of the double-blind randomized
withdrawal period.
Key
Query!
Minimum age
12
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. Has a diagnosis of pericarditis that is secondary to specific prohibited etiologies.
2. Has a history of immunosuppression, including positive human immunodeficiency virus
(HIV) test results.
3. Has a history of myeloproliferative disorder.
4. Has a history of demyelinating disease or symptoms suggestive of multiple sclerosis.
5. Has a history of active or latent tuberculosis (TB) prior to screening
6. Has chest x-ray at screening or within 12 weeks before receiving first administration
of study drug, with evidence of malignancy or abnormality consistent with prior or
active TB infection.
7. Has a history of positive or intermediate results for hepatitis B surface antigen,
hepatitis B core antibody, or hepatitis C virus antibody at screening.
8. Has a history of malignancy of any organ system within the past 5 years before
screening (other than a successfully treated non metastatic cutaneous squamous cell
carcinoma or basal cell carcinoma and/or localized carcinoma in situ of the cervix).
9. Has a known or suspected current active infection or a history of chronic or recurrent
infectious disease, including, but not limited to, chronic renal infection, chronic
chest infection, sinusitis, recurrent urinary tract infection, or an open, draining
infected skin wound.
10. Has had an organ transplant.
11. In the Investigator's opinion, has a history of alcoholism or drug/chemical abuse
within 2 years before screening.
12. Has a known hypersensitivity to rilonacept or to any of its excipients.
13. Has received an investigational drug during the 30 days before screening or is
planning to receive an investigational drug (other than that administered during this
study) or use an investigational device at any time during the study.
14. In the Investigator's opinion, has any other medical condition that could adversely
affect the subject's participation or interfere with study evaluations.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
7/01/2019
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
30/06/2022
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
86
Query!
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Query!
Recruitment hospital [1]
0
0
HeartCare Partners Clinical Research Unit - Milton
Query!
Recruitment hospital [2]
0
0
GenesisCare - Cardiology Research - Doncaster East
Query!
Recruitment postcode(s) [1]
0
0
40664 - Milton
Query!
Recruitment postcode(s) [2]
0
0
3109 - Doncaster East
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Georgia
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Illinois
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Minnesota
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Ohio
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Pennsylvania
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Utah
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Vermont
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Virginia
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Washington
Query!
Country [11]
0
0
Israel
Query!
State/province [11]
0
0
Haifa
Query!
Country [12]
0
0
Israel
Query!
State/province [12]
0
0
Jerusalem
Query!
Country [13]
0
0
Israel
Query!
State/province [13]
0
0
Nahariya
Query!
Country [14]
0
0
Israel
Query!
State/province [14]
0
0
Ramat Gan
Query!
Country [15]
0
0
Italy
Query!
State/province [15]
0
0
Lazio
Query!
Country [16]
0
0
Italy
Query!
State/province [16]
0
0
Lombardy
Query!
Country [17]
0
0
Italy
Query!
State/province [17]
0
0
Piedmont
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Kiniksa Pharmaceuticals (UK), Ltd.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The primary objective of this study was to assess the efficacy of rilonacept treatment in
participants with recurrent pericarditis.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03737110
Query!
Trial related presentations / publications
Klein AL, Imazio M, Cremer P, Brucato A, Abbate A, Fang F, Insalaco A, LeWinter M, Lewis BS, Lin D, Luis SA, Nicholls SJ, Pano A, Wheeler A, Paolini JF; RHAPSODY Investigators. Phase 3 Trial of Interleukin-1 Trap Rilonacept in Recurrent Pericarditis. N Engl J Med. 2021 Jan 7;384(1):31-41. doi: 10.1056/NEJMoa2027892. Epub 2020 Nov 16.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Clinical Operations Study Director
Query!
Address
0
0
Kiniksa Pharmaceuticals (UK), Ltd.
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03737110
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