Recurrent Pericarditis
Conditions
Brief summary
The primary objective of this study was to assess the efficacy of rilonacept treatment in participants with recurrent pericarditis.
Detailed description
In the single-blind run-in (RI) period, rilonacept 320 mg (or 4.4 mg/kg in pediatric participants ≥12 and \<18 years old) subcutaneous (SC), followed by 160 mg (or 2.2 mg/kg in pediatric participants ≥12 and \<18 years old) injections once weekly. During the Randomized-Withdrawal (RW) period, eligible participants are randomized 1:1 to double-blinded administration of study drug: * Rilonacept 160 mg (or 2.2 mg/kg in pediatric participants ≥12 and \<18 years old) SC injections once weekly * Matching 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 numerical rating scale (NRS) and have 1 C-reactive protein (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 \[or 4.4 mg/kg for pediatric subjects\]) irrespective of randomized treatment assignment and as soon as at least 5 days have passed since the last study drug injection. Upon completion of the RW period (i.e., when the prespecified number of primary efficacy endpoints \[clinical events committee-confirmed pericarditis recurrence\] events have occurred), all participants who did not discontinue study drug have an option to continue treatment with open-label rilonacept in the Long-Term Extension (LTE) or to withdraw from the study. Participants still in the RI period at the time that the RW period has ended and the LTE is opened will have the option to enter the LTE directly when they have completed the RI period and have met the definition of clinical response or to withdraw from the study.
Interventions
DRUGRilonacept
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
DRUGPlacebo
Placebo SC injections once weekly
Sponsors
Kiniksa Pharmaceuticals (UK), Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Pericarditis Recurrence in the RW Period | RW Period (mean 24.8 weeks) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Secondary Efficacy Endpoint: Percentage of Participants Who Maintained Clinical Response at Week 16 of the RW Period | RW Period Week 16 | 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. |
| Major Secondary Efficacy Endpoint: Percentage of Days With No or Minimal Pericarditis Pain at Week 16 of the RW Period | RW Period Week 16 | 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. |
| 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 | RW Period Week 16 | 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. |
| Percentage of Participants Who Maintained Clinical Response at Week 8 of the RW Period | RW Period Week 8 | 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. |
| Percentage of Days With No or Minimal Pericarditis Pain at Week 24 of the RW Period | RW Period Week 24 | 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. |
| Percentage of Days With No or Minimal Pericarditis Pain at Week 8 of the RW Period | RW Period Week 8 | 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. |
| Percentage of Participants With Absent or Minimal Pericarditis Symptoms at Week 24 of the RW Period Based on the PGIPS | RW Period Week 24 | 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. |
| Percentage of Participants With Absent or Minimal Pericarditis Symptoms at Week 8 of the RW Period Based on the PGIPS | RW Period Week 8 | 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. |
| Percentage of Participants Without Pericarditis Recurrence in the First 24 Weeks of the RW Period | up to 24 weeks in the RW Period | 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. |
| Time to Pericarditis Pain ≥ 4 on the NRS in the RW Period | RW Period (mean 24.8 weeks) | 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 CRP Level ≥ 1 mg/dL in the RW Period | RW Period (mean 24.8 weeks) | Kaplan-Meier estimate. |
| Time to Pericardial Rub in the RW Period | RW Period (mean 24.8 weeks) | Kaplan-Meier estimate. A pericardial rub (also called a pericardial friction rub) is an audible medical sign used in the diagnosis of pericarditis. |
| Time to Widespread ST-segment Elevation or PR-segment Depression on Electrocardiogram (ECG) in the RW Period | RW Period (mean 24.8 weeks) | Kaplan-Meier estimate. ST-segment elevation and PR-segment depression are ECG changes in the evolution of acute pericarditis. |
| Time to New or Worsening Pericardial Effusion on Echocardiography (ECHO) in the RW Period | RW Period (mean 24.8 weeks) | Pericardial effusion based on ECHO was evaluated by the central laboratory during the RW period. Kaplan-Meier estimate. |
| Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Period Baseline, RW Period Week 24, RW Period (mean 24.8 weeks) | 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). |
| Change From RW Period Baseline Over Time in CRP Levels in RW Period | RW Period Baseline, RW Period Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 56 | Estimated from ANCOVA models including treatment arm as fix effect, baseline value, baseline value by treatment interaction, randomization strata as covariates. |
| Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | RW Period Baseline, RW Period Weeks 1-50, 54 | 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. |
| Percentage of Participants With Absent or Minimal Pericarditis Symptoms Over Time After RW Period Week 24 Based on the PGIPS | RW Period Weeks 32, 40, 48, 56 | 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. |
| 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) | RW Period Baseline, RW Period Weeks 8, 16, 24, 32, 40, 48, 56 | 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. |
| Change From RW Period Baseline in Short Form-36 (SF-36) Physical and Mental Component Scores at RW Period Week 24 | RW Period Baseline, RW Period Week 24 | 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. |
| Change From RW Baseline in SF-36 Individual Scores at RW Period Week 24 | RW Period Baseline, RW Period Week 24 | 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. |
| Change From RW Period Baseline in the Short Form Health Survey-6 Domains (SF-6D) Utility Index Score at RW Period Week 24 | RW Period Baseline, RW Period Week 24 | 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). |
| Change From RW Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value to RW Period Week 24 | RW Period Baseline, RW Period Week 24 | 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. |
| Change From RW Period Baseline in Insomnia Severity Index (ISI) Total Score at RW Period Week 24 | RW Period Baseline, RW Period Week 24 | 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). |
| Change in ISI Categories From RW Period Baseline to RW Period Week 24 | RW Period Baseline (BL), RW Period Week (Wk) 24 | 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). |
| Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | RW Period (mean 24.8 weeks) | 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. |
| Percentage of Participants Using ORT for Pericarditis in the First 24 Weeks of RW Period | RW Period (up to Week 24) | ORT included analgesics, NSAIDs, and/or colchicine. |
| Percentage of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion on Magnetic Resonance Imaging (MRI) at RW Week 24 | RW Period Week 24 | 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 |
| Time From First Dose to Pain Response in the RI Period | RI Period (up to 12 weeks) | 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. |
| Time From First Dose to CRP Normalization in the RI Period | RI Period (up to 12 weeks) | 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. |
| Time From First Dose to Rilonacept Monotherapy in RI Period | RI Period (up to 12 weeks) | Time to rilonacept monotherapy was defined as the number of weeks from first dose to the first day of achieving monotherapy. |
| Time From First Dose to Treatment Response in RI Period | RI Period (up to 12 weeks) | 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. |
| Percentage of Participants Achieving Clinical Response at RI Period Week 12 | RI Period Week 12 | 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. |
| Percentage of Participants With CRP Normalization at RI Period Week 12 | RI Period Week 12 | CRP normalization was defined as CRP ≤ 0.5 mg/dL. |
| Change From Baseline Over Time in Weekly Average of Pericarditis Pain NRS Score in RI Period | RI Period Baseline, RI Period Weeks 1-12 | 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'. |
| Change From Baseline Over Time in CRP Levels in RI Period | RI Period Baseline, RI Period Day 4, Weeks 1, 2, 4, 6, 12 | — |
| Percentage of Participants With Resolution of Pericarditis-Related ECHO and ECG Abnormalities at Week 12 of the RI Period | RI Period Baseline, RI Period Week 12 | — |
| Percentage of Days With No or Minimal Pain in the RI Period While on Treatment | RI Period (up to Week 12) | 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'. |
| Percentage of Participants With No or Minimal Pericarditis Symptoms Over Time in the RI Period, Based on the PGIPS | RI Period Baseline, RI Period Weeks 6 and 12 | 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. |
| Percentage of Participants With No or Minimal Pericarditis Activity Over Time in the RI Period, Based on the PGA-PA | RI Period Baseline, RI Period Weeks 6 and 12 | 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. |
| Change From RI Period Baseline in the SF-36 Domain Scores and Physical and Mental Scores to RI Period Week 12 | RI Period Baseline, RI Period Week 12 | 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. |
| Change From RI Period Baseline in SF-6D Scores at RI Period Week 12 | RI Period Baseline, RI Period Week 12 | 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). |
| Change From RI Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value at RI Period Week 12 | RI Period Baseline, RI Period Week 12 | 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. |
| Change From RI Period Baseline in ISI Total Score at RI Period Week 12 | RI Period Baseline, RI Period Week 12 | 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). |
| Change in ISI Categories From RI Period Baseline to RI Period Week 12 | RI Period Baseline (BL), RI Period Week (Wk) 12 | 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). |
| Number of Participants Who Were Off Background Pericarditis Medication on or Before RI Period Weeks 4, 8, 10, and 12 | RI Period Baseline, RI Period Weeks 4, 8, 10, 12 | — |
| Annualized Rate of Pericarditis Recurrence in the Long-Term Extension (LTE) Period Based on Investigator's Assessment (Based on Investigators' Judgement) | LTE Period, through LTE Follow up (up to Week 48) | 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. |
| Change From LTE Baseline Over Time in CRP Levels | LTE Baseline, LTE Week 12, LTE Week 24 | — |
| Percentage of Participants With Absent or Minimal Pericarditis Activity In the LTE Period Based on the PGIPS | LTE Baseline, LTE Month 12, LTE Month 24 | 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). |
| Percentage of Participants With Absent or Minimal Pericarditis Activity Over Time in the LTE Period Based on the PGA-PA | LTE Baseline, LTE Week 12, LTE Week 24 | 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. |
| Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | LTE Baseline, LTE Week 24 | 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. |
| Change From LTE Baseline in SF-6D Health Utility Index Score | LTE Baseline, LTE Week 24 | 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). |
| Change From LTE Baseline in EQ-5D-5L Individual Scores and Index Value | LTE Baseline, LTE Week 24 | 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. |
| Change From LTE Baseline in ISI Total Score | LTE Baseline, LTE Week 24 | 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). |
| Percentage of Participants Who Maintained Clinical Response at Week 24 of the RW Period | RW Period Week 24 | 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. |
| Percentage of Participants Requiring Addition of Standard of Care (SOC) Pericarditis Therapy Every 4 Weeks Cumulatively in the LTE Period | LTE Period, through LTE Follow up (up to Week 24) | — |
| Change From LTE Baseline in Pericardial Signs in ECHO | LTE Baseline, LTE Week 24 | — |
| Change From LTE Baseline in Pericardial Signs in ECG | LTE Baseline, LTE Week 24 | — |
| Change From LTE Baseline in Pericardial Signs in MRI | LTE Baseline, LTE Week 24 | — |
| Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE Week 24 | — |
| Annualized Rate of Pericarditis Recurrence in LTE Periods Based on Investigator's Assessment | LTE Period, through LTE Follow up (up to Week 48) | 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. |
| Annualized Rate of Pericarditis Recurrence in RW Period Based on CEC Adjudication | RW Period (mean 24.8 weeks) | 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. |
| Change From LTE Baseline in ISI Categories | LTE Baseline (BL), LTE Week 24 | 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). |
Countries
Australia, Israel, Italy, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Randomized Withdrawal Period: Rilonacept Double-blind rilonacept 160 mg (or 2.2 mg/kg in pediatric participants ≥ 12 and \< 18 years old) SC injections once weekly. | 30 |
| Randomized Withdrawal Period: Placebo Double-blind placebo SC injections once weekly. | 31 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Long-Term Extension (LTE) Period | Investigator Decision due to Serious Adverse Event | 0 | 0 | 0 | 0 | 1 | 0 |
| Long-Term Extension (LTE) Period | Lost to Follow-up | 0 | 0 | 0 | 1 | 0 | 0 |
| Long-Term Extension (LTE) Period | Withdrawal by Subject | 0 | 0 | 0 | 1 | 0 | 2 |
| Randomized Withdrawal (RW) Period | Completed, Not Continuing into LTE | 0 | 1 | 0 | 0 | 0 | 0 |
| Randomized Withdrawal (RW) Period | Withdrawal by Subject | 0 | 0 | 1 | 0 | 0 | 0 |
| Run-in (RI) Period | Adverse Event | 4 | 0 | 0 | 0 | 0 | 0 |
| Run-in (RI) Period | Did Not Meet Clinical Response Criteria | 3 | 0 | 0 | 0 | 0 | 0 |
| Run-in (RI) Period | Lack of Efficacy | 3 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Randomized Withdrawal Period: Rilonacept | Randomized Withdrawal Period: Placebo | Total |
|---|---|---|---|
| Age, Continuous | 48.0 years STANDARD_DEVIATION 15.7 | 44.8 years STANDARD_DEVIATION 14.47 | 46.4 years STANDARD_DEVIATION 15.05 |
| Age, Customized 12 to 17 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Customized 18 to 64 years | 24 Participants | 27 Participants | 51 Participants |
| Age, Customized 65 to 78 years | 5 Participants | 2 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants | 31 Participants | 61 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Other, Not Specified | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 28 Participants | 28 Participants | 56 Participants |
| Sex: Female, Male Female | 16 Participants | 16 Participants | 32 Participants |
| Sex: Female, Male Male | 14 Participants | 15 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 86 | 0 / 30 | 0 / 30 | 0 / 31 | 0 / 31 | 0 / 74 |
| other Total, other adverse events | 55 / 86 | 18 / 30 | 18 / 30 | 7 / 31 | 13 / 31 | 43 / 74 |
| serious Total, serious adverse events | 1 / 86 | 1 / 30 | 1 / 30 | 1 / 31 | 3 / 31 | 6 / 74 |
Outcome results
Primary
Time to Pericarditis Recurrence in the RW Period
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).
Time frame: RW Period (mean 24.8 weeks)
Population: Intent-to-Treat (ITT) Analysis Set: all participants who were randomized in the RW period.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Time to Pericarditis Recurrence in the RW Period | NA weeks |
| Randomized Withdrawal Period: Placebo | Time to Pericarditis Recurrence in the RW Period | 8.6 weeks |
p-value: <0.000195% CI: [0.01, 0.18]Log Rank
Secondary
Annualized Rate of Pericarditis Recurrence in LTE Periods Based on Investigator's Assessment
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.
Time frame: LTE Period, through LTE Follow up (up to Week 48)
Population: LTE Analysis Set: participants who consented to LTE period and took at least 1 dose of study drug in the LTE period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Annualized Rate of Pericarditis Recurrence in LTE Periods Based on Investigator's Assessment | 0.088 recurrences per participant per year |
| Randomized Withdrawal Period: Placebo | Annualized Rate of Pericarditis Recurrence in LTE Periods Based on Investigator's Assessment | 0.168 recurrences per participant per year |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Annualized Rate of Pericarditis Recurrence in LTE Periods Based on Investigator's Assessment | 0.125 recurrences per participant per year |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Annualized Rate of Pericarditis Recurrence in LTE Periods Based on Investigator's Assessment | 0.132 recurrences per participant per year |
Secondary
Annualized Rate of Pericarditis Recurrence in RW Period Based on CEC Adjudication
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.
Time frame: RW Period (mean 24.8 weeks)
Population: ITT Analysis Set: all participants who were randomized in the RW period. Participants who received rilonacept in the RW period only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Annualized Rate of Pericarditis Recurrence in RW Period Based on CEC Adjudication | 0.137 recurrences per participant per year |
Secondary
Annualized Rate of Pericarditis Recurrence in the Long-Term Extension (LTE) Period Based on Investigator's Assessment (Based on Investigators' Judgement)
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.
Time frame: LTE Period, through LTE Follow up (up to Week 48)
Population: LTE Analysis Set: participants who consented to LTE period and took at least 1 dose of study drug in the LTE period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Annualized Rate of Pericarditis Recurrence in the Long-Term Extension (LTE) Period Based on Investigator's Assessment (Based on Investigators' Judgement) | 0.088 recurrences per participant per year |
| Randomized Withdrawal Period: Placebo | Annualized Rate of Pericarditis Recurrence in the Long-Term Extension (LTE) Period Based on Investigator's Assessment (Based on Investigators' Judgement) | 0.168 recurrences per participant per year |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Annualized Rate of Pericarditis Recurrence in the Long-Term Extension (LTE) Period Based on Investigator's Assessment (Based on Investigators' Judgement) | 0.125 recurrences per participant per year |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Annualized Rate of Pericarditis Recurrence in the Long-Term Extension (LTE) Period Based on Investigator's Assessment (Based on Investigators' Judgement) | 0.132 recurrences per participant per year |
Secondary
Change From Baseline Over Time in CRP Levels in RI Period
Time frame: RI Period Baseline, RI Period Day 4, Weeks 1, 2, 4, 6, 12
Population: Run-in Analysis Set: All participants who received at least 1 dose of study drug in the RI period. Participants with an assessment at given time period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Change From Baseline Over Time in CRP Levels in RI Period | Change at RI Week 6 | -3.55 mg/dL | Standard Deviation 5.899 |
| Randomized Withdrawal Period: Rilonacept | Change From Baseline Over Time in CRP Levels in RI Period | Change at RI Week 12 | -3.60 mg/dL | Standard Deviation 5.916 |
| Randomized Withdrawal Period: Rilonacept | Change From Baseline Over Time in CRP Levels in RI Period | RI Baseline | 3.72 mg/dL | Standard Deviation 5.719 |
| Randomized Withdrawal Period: Rilonacept | Change From Baseline Over Time in CRP Levels in RI Period | Change at RI Day 4 | -2.80 mg/dL | Standard Deviation 4.582 |
| Randomized Withdrawal Period: Rilonacept | Change From Baseline Over Time in CRP Levels in RI Period | Change at RI Week 1 | -3.48 mg/dL | Standard Deviation 5.539 |
| Randomized Withdrawal Period: Rilonacept | Change From Baseline Over Time in CRP Levels in RI Period | Change at RI Week 2 | -3.55 mg/dL | Standard Deviation 5.717 |
| Randomized Withdrawal Period: Rilonacept | Change From Baseline Over Time in CRP Levels in RI Period | Change at RI Week 4 | -3.46 mg/dL | Standard Deviation 5.809 |
Secondary
Change From Baseline Over Time in Weekly Average of Pericarditis Pain NRS Score in RI Period
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 frame: RI Period Baseline, RI Period Weeks 1-12
Population: Run-in Analysis Set: All participants who received at least 1 dose of study drug in the RI period. Participants with an assessment at given time period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Change From Baseline Over Time in Weekly Average of Pericarditis Pain NRS Score in RI Period | RI Baseline | 4.48 score on a scale | Standard Deviation 2.51 |
| Randomized Withdrawal Period: Rilonacept | Change From Baseline Over Time in Weekly Average of Pericarditis Pain NRS Score in RI Period | Change at RI Week 1 | -2.31 score on a scale | Standard Deviation 2.187 |
| Randomized Withdrawal Period: Rilonacept | Change From Baseline Over Time in Weekly Average of Pericarditis Pain NRS Score in RI Period | Change at RI Week 2 | -3.18 score on a scale | Standard Deviation 2.605 |
| Randomized Withdrawal Period: Rilonacept | Change From Baseline Over Time in Weekly Average of Pericarditis Pain NRS Score in RI Period | Change at RI Week 3 | -3.28 score on a scale | Standard Deviation 2.547 |
| Randomized Withdrawal Period: Rilonacept | Change From Baseline Over Time in Weekly Average of Pericarditis Pain NRS Score in RI Period | Change at RI Week 4 | -3.51 score on a scale | Standard Deviation 2.614 |
| Randomized Withdrawal Period: Rilonacept | Change From Baseline Over Time in Weekly Average of Pericarditis Pain NRS Score in RI Period | Change at RI Week 5 | -3.55 score on a scale | Standard Deviation 2.661 |
| Randomized Withdrawal Period: Rilonacept | Change From Baseline Over Time in Weekly Average of Pericarditis Pain NRS Score in RI Period | Change at RI Week 6 | -3.70 score on a scale | Standard Deviation 2.615 |
| Randomized Withdrawal Period: Rilonacept | Change From Baseline Over Time in Weekly Average of Pericarditis Pain NRS Score in RI Period | Change at RI Week 7 | -3.81 score on a scale | Standard Deviation 2.663 |
| Randomized Withdrawal Period: Rilonacept | Change From Baseline Over Time in Weekly Average of Pericarditis Pain NRS Score in RI Period | Change at RI Week 8 | -3.92 score on a scale | Standard Deviation 2.569 |
| Randomized Withdrawal Period: Rilonacept | Change From Baseline Over Time in Weekly Average of Pericarditis Pain NRS Score in RI Period | Change at RI Week 9 | -3.81 score on a scale | Standard Deviation 2.727 |
| Randomized Withdrawal Period: Rilonacept | Change From Baseline Over Time in Weekly Average of Pericarditis Pain NRS Score in RI Period | Change at RI Week 10 | -3.83 score on a scale | Standard Deviation 2.649 |
| Randomized Withdrawal Period: Rilonacept | Change From Baseline Over Time in Weekly Average of Pericarditis Pain NRS Score in RI Period | Change at RI Week 11 | -4.05 score on a scale | Standard Deviation 2.596 |
| Randomized Withdrawal Period: Rilonacept | Change From Baseline Over Time in Weekly Average of Pericarditis Pain NRS Score in RI Period | Change at RI Week 12 | -4.00 score on a scale | Standard Deviation 2.658 |
Secondary
Change From LTE Baseline in EQ-5D-5L Individual Scores and Index Value
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.
Time frame: LTE Baseline, LTE Week 24
Population: Long term extension (LTE) Analysis Set: participants who consented to LTE period and took at least 1 dose of study drug in the LTE period. Participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in EQ-5D-5L Individual Scores and Index Value | Mobility: Change at LTE Week 24 | -0.2 score on a scale | Standard Deviation 0.7 |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in EQ-5D-5L Individual Scores and Index Value | Index Score: Change at Week 24 | 0.0546 score on a scale | Standard Deviation 0.19544 |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in EQ-5D-5L Individual Scores and Index Value | Anxiety/Depression: Change at Week 24 | -0.1 score on a scale | Standard Deviation 0.73 |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in EQ-5D-5L Individual Scores and Index Value | Self-Care: Change at LTE Week 24 | 0.1 score on a scale | Standard Deviation 1 |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in EQ-5D-5L Individual Scores and Index Value | VAS Score: Change at Week 24 | 6.2 score on a scale | Standard Deviation 25.95 |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in EQ-5D-5L Individual Scores and Index Value | Usual Activities: Change at LTE Week 24 | -0.1 score on a scale | Standard Deviation 1.35 |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in EQ-5D-5L Individual Scores and Index Value | Pain/Discomfort: Change at Week 24 | -0.3 score on a scale | Standard Deviation 1.2 |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in EQ-5D-5L Individual Scores and Index Value | Index Score: Change at Week 24 | 0.0290 score on a scale | Standard Deviation 0.10339 |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in EQ-5D-5L Individual Scores and Index Value | Pain/Discomfort: Change at Week 24 | -0.2 score on a scale | Standard Deviation 0.85 |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in EQ-5D-5L Individual Scores and Index Value | Usual Activities: Change at LTE Week 24 | 0.0 score on a scale | Standard Deviation 0.8 |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in EQ-5D-5L Individual Scores and Index Value | Anxiety/Depression: Change at Week 24 | 0.1 score on a scale | Standard Deviation 0.67 |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in EQ-5D-5L Individual Scores and Index Value | VAS Score: Change at Week 24 | 12.6 score on a scale | Standard Deviation 27.07 |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in EQ-5D-5L Individual Scores and Index Value | Self-Care: Change at LTE Week 24 | -0.1 score on a scale | Standard Deviation 0.29 |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in EQ-5D-5L Individual Scores and Index Value | Mobility: Change at LTE Week 24 | 0.0 score on a scale | Standard Deviation 0.77 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in EQ-5D-5L Individual Scores and Index Value | Pain/Discomfort: Change at Week 24 | 0.0 score on a scale | Standard Deviation 0.67 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in EQ-5D-5L Individual Scores and Index Value | Mobility: Change at LTE Week 24 | 0.1 score on a scale | Standard Deviation 0.48 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in EQ-5D-5L Individual Scores and Index Value | Self-Care: Change at LTE Week 24 | 0.0 score on a scale | Standard Deviation 0.18 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in EQ-5D-5L Individual Scores and Index Value | Usual Activities: Change at LTE Week 24 | -0.1 score on a scale | Standard Deviation 0.45 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in EQ-5D-5L Individual Scores and Index Value | Anxiety/Depression: Change at Week 24 | 0.0 score on a scale | Standard Deviation 0.72 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in EQ-5D-5L Individual Scores and Index Value | Index Score: Change at Week 24 | -0.0004 score on a scale | Standard Deviation 0.10212 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in EQ-5D-5L Individual Scores and Index Value | VAS Score: Change at Week 24 | -0.2 score on a scale | Standard Deviation 9.48 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in EQ-5D-5L Individual Scores and Index Value | Usual Activities: Change at LTE Week 24 | -0.1 score on a scale | Standard Deviation 0.81 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in EQ-5D-5L Individual Scores and Index Value | VAS Score: Change at Week 24 | 5.5 score on a scale | Standard Deviation 21.19 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in EQ-5D-5L Individual Scores and Index Value | Index Score: Change at Week 24 | 0.0212 score on a scale | Standard Deviation 0.12704 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in EQ-5D-5L Individual Scores and Index Value | Self-Care: Change at LTE Week 24 | 0.0 score on a scale | Standard Deviation 0.49 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in EQ-5D-5L Individual Scores and Index Value | Mobility: Change at LTE Week 24 | 0.0 score on a scale | Standard Deviation 0.64 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in EQ-5D-5L Individual Scores and Index Value | Anxiety/Depression: Change at Week 24 | 0.0 score on a scale | Standard Deviation 0.7 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in EQ-5D-5L Individual Scores and Index Value | Pain/Discomfort: Change at Week 24 | -0.1 score on a scale | Standard Deviation 0.86 |
Secondary
Change From LTE Baseline in ISI Categories
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).
Time frame: LTE Baseline (BL), LTE Week 24
Population: Long term extension (LTE) Analysis Set: participants who consented to LTE period and took at least 1 dose of study drug in the LTE period. Participants 18 years or older with an assessment at given time point.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Subthreshold Insomnia | LTE Week 24 Missing | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL No Clinically Significant Insomnia | LTE Week 24 Clinical Insomnia (Severe) | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Missing | LTE Week 24 Clinical Insomnia (Moderate Severity) | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Subthreshold Insomnia | LTE Week 24 Clinical Insomnia (Severe) | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Subthreshold Insomnia | LTE Week 24 Clinical Insomnia (Moderate Severity) | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL No Clinically Significant Insomnia | LTE Week 24 Missing | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Severe) | LTE Week 24 Clinical Insomnia (Severe) | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Subthreshold Insomnia | LTE Week 24 Subthreshold Insomnia | 2 Participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Subthreshold Insomnia | LTE Week 24 No Clinically Significant Insomnia | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Severe) | LTE Week 24 Clinical Insomnia (Moderate Severity) | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Missing | LTE Week 24 Missing | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Missing | LTE Week 24 Subthreshold Insomnia | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Severe) | LTE Week 24 Subthreshold Insomnia | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Severe) | LTE Week 24 No Clinically Significant Insomnia | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL No Clinically Significant Insomnia | LTE Week 24 No Clinically Significant Insomnia | 9 Participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Missing | LTE Week 24 No Clinically Significant Insomnia | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Moderate Severity) | LTE Week 24 Missing | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Moderate Severity) | LTE Week 24 Clinical Insomnia (Severe) | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL No Clinically Significant Insomnia | LTE Week 24 Subthreshold Insomnia | 1 Participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Severe) | LTE Week 24 Missing | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Moderate Severity) | LTE Week 24 Clinical Insomnia (Moderate Severity) | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Moderate Severity) | LTE Week 24 Subthreshold Insomnia | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL No Clinically Significant Insomnia | LTE Week 24 Clinical Insomnia (Moderate Severity) | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Missing | LTE Week 24 Clinical Insomnia (Severe) | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Moderate Severity) | LTE Week 24 No Clinically Significant Insomnia | 0 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in ISI Categories | LTE BL Missing | LTE Week 24 Subthreshold Insomnia | 0 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in ISI Categories | LTE BL Missing | LTE Week 24 Clinical Insomnia (Moderate Severity) | 0 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in ISI Categories | LTE BL Missing | LTE Week 24 Clinical Insomnia (Severe) | 0 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in ISI Categories | LTE BL Missing | LTE Week 24 Missing | 0 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in ISI Categories | LTE BL No Clinically Significant Insomnia | LTE Week 24 No Clinically Significant Insomnia | 11 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in ISI Categories | LTE BL No Clinically Significant Insomnia | LTE Week 24 Subthreshold Insomnia | 2 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in ISI Categories | LTE BL No Clinically Significant Insomnia | LTE Week 24 Clinical Insomnia (Moderate Severity) | 0 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in ISI Categories | LTE BL No Clinically Significant Insomnia | LTE Week 24 Clinical Insomnia (Severe) | 1 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in ISI Categories | LTE BL No Clinically Significant Insomnia | LTE Week 24 Missing | 0 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in ISI Categories | LTE BL Subthreshold Insomnia | LTE Week 24 No Clinically Significant Insomnia | 2 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in ISI Categories | LTE BL Subthreshold Insomnia | LTE Week 24 Subthreshold Insomnia | 2 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in ISI Categories | LTE BL Subthreshold Insomnia | LTE Week 24 Clinical Insomnia (Severe) | 0 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in ISI Categories | LTE BL Subthreshold Insomnia | LTE Week 24 Clinical Insomnia (Moderate Severity) | 1 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in ISI Categories | LTE BL Subthreshold Insomnia | LTE Week 24 Missing | 1 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Moderate Severity) | LTE Week 24 No Clinically Significant Insomnia | 1 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Moderate Severity) | LTE Week 24 Subthreshold Insomnia | 2 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Moderate Severity) | LTE Week 24 Clinical Insomnia (Moderate Severity) | 0 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Moderate Severity) | LTE Week 24 Clinical Insomnia (Severe) | 0 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Moderate Severity) | LTE Week 24 Missing | 0 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Severe) | LTE Week 24 No Clinically Significant Insomnia | 0 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Severe) | LTE Week 24 Subthreshold Insomnia | 0 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Severe) | LTE Week 24 Clinical Insomnia (Moderate Severity) | 0 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Severe) | LTE Week 24 Clinical Insomnia (Severe) | 0 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Severe) | LTE Week 24 Missing | 1 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in ISI Categories | LTE BL Missing | LTE Week 24 No Clinically Significant Insomnia | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Missing | LTE Week 24 Clinical Insomnia (Moderate Severity) | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Severe) | LTE Week 24 No Clinically Significant Insomnia | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Moderate Severity) | LTE Week 24 Clinical Insomnia (Moderate Severity) | 1 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Missing | LTE Week 24 Missing | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Missing | LTE Week 24 Subthreshold Insomnia | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Severe) | LTE Week 24 Subthreshold Insomnia | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL No Clinically Significant Insomnia | LTE Week 24 Clinical Insomnia (Moderate Severity) | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Subthreshold Insomnia | LTE Week 24 Missing | 1 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Missing | LTE Week 24 No Clinically Significant Insomnia | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Severe) | LTE Week 24 Missing | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Severe) | LTE Week 24 Clinical Insomnia (Moderate Severity) | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Subthreshold Insomnia | LTE Week 24 No Clinically Significant Insomnia | 3 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Moderate Severity) | LTE Week 24 Clinical Insomnia (Severe) | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL No Clinically Significant Insomnia | LTE Week 24 Missing | 1 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Moderate Severity) | LTE Week 24 Subthreshold Insomnia | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Subthreshold Insomnia | LTE Week 24 Subthreshold Insomnia | 2 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Missing | LTE Week 24 Clinical Insomnia (Severe) | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL No Clinically Significant Insomnia | LTE Week 24 No Clinically Significant Insomnia | 18 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Moderate Severity) | LTE Week 24 No Clinically Significant Insomnia | 1 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Moderate Severity) | LTE Week 24 Missing | 1 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Subthreshold Insomnia | LTE Week 24 Clinical Insomnia (Moderate Severity) | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL No Clinically Significant Insomnia | LTE Week 24 Subthreshold Insomnia | 4 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL No Clinically Significant Insomnia | LTE Week 24 Clinical Insomnia (Severe) | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Subthreshold Insomnia | LTE Week 24 Clinical Insomnia (Severe) | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Severe) | LTE Week 24 Clinical Insomnia (Severe) | 0 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Subthreshold Insomnia | LTE Week 24 Clinical Insomnia (Severe) | 0 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Subthreshold Insomnia | LTE Week 24 Missing | 2 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Severe) | LTE Week 24 Clinical Insomnia (Severe) | 0 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Moderate Severity) | LTE Week 24 No Clinically Significant Insomnia | 2 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL No Clinically Significant Insomnia | LTE Week 24 Subthreshold Insomnia | 7 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Missing | LTE Week 24 Clinical Insomnia (Moderate Severity) | 0 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Moderate Severity) | LTE Week 24 Subthreshold Insomnia | 2 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Missing | LTE Week 24 Subthreshold Insomnia | 0 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Moderate Severity) | LTE Week 24 Clinical Insomnia (Moderate Severity) | 1 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL No Clinically Significant Insomnia | LTE Week 24 No Clinically Significant Insomnia | 38 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Moderate Severity) | LTE Week 24 Clinical Insomnia (Severe) | 0 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Severe) | LTE Week 24 Missing | 1 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Moderate Severity) | LTE Week 24 Missing | 1 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Missing | LTE Week 24 Missing | 0 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Severe) | LTE Week 24 No Clinically Significant Insomnia | 0 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Severe) | LTE Week 24 Subthreshold Insomnia | 0 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Missing | LTE Week 24 Clinical Insomnia (Severe) | 0 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL No Clinically Significant Insomnia | LTE Week 24 Missing | 1 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Subthreshold Insomnia | LTE Week 24 No Clinically Significant Insomnia | 5 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Clinical Insomnia (Severe) | LTE Week 24 Clinical Insomnia (Moderate Severity) | 0 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Subthreshold Insomnia | LTE Week 24 Subthreshold Insomnia | 6 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL No Clinically Significant Insomnia | LTE Week 24 Clinical Insomnia (Severe) | 1 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Missing | LTE Week 24 No Clinically Significant Insomnia | 0 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL Subthreshold Insomnia | LTE Week 24 Clinical Insomnia (Moderate Severity) | 1 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in ISI Categories | LTE BL No Clinically Significant Insomnia | LTE Week 24 Clinical Insomnia (Moderate Severity) | 0 Participants |
Secondary
Change From LTE Baseline in ISI Total Score
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).
Time frame: LTE Baseline, LTE Week 24
Population: Long term extension (LTE) Analysis Set: participants who consented to LTE period and took at least 1 dose of study drug in the LTE period. Participants 18 years or older with an assessment at given time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in ISI Total Score | -0.3 score on a scale | Standard Deviation 1.87 |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in ISI Total Score | -0.2 score on a scale | Standard Deviation 6.87 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in ISI Total Score | -1.1 score on a scale | Standard Deviation 3.58 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in ISI Total Score | -0.1 score on a scale | Standard Deviation 0.89 |
Secondary
Change From LTE Baseline in Pericardial Signs in ECG
Time frame: LTE Baseline, LTE Week 24
Population: Long term extension (LTE) Analysis Set: participants who consented to LTE period and took at least 1 dose of study drug in the LTE period. Participants with an assessment at given time point.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in ECG | LTE Baseline | Normal | 7 Participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in ECG | LTE Baseline | Abnormal-Consistent With Pericarditis | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in ECG | LTE Baseline | Abnormal-Not Consistent With Pericarditis But Clinically Significant | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in ECG | LTE Baseline | Abnormal-Not Consistent With Pericarditis But Not Clinically Significant | 8 Participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in ECG | LTE Week 24 | Normal | 8 Participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in ECG | LTE Week 24 | Abnormal-Consistent With Pericarditis | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in ECG | LTE Week 24 | Abnormal-Not Consistent With Pericarditis But Clinically Significant | 1 Participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in ECG | LTE Week 24 | Abnormal-Not Consistent With Pericarditis But Not Clinically Significant | 6 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in ECG | LTE Week 24 | Abnormal-Consistent With Pericarditis | 1 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in ECG | LTE Week 24 | Normal | 15 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in ECG | LTE Baseline | Abnormal-Consistent With Pericarditis | 1 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in ECG | LTE Week 24 | Abnormal-Not Consistent With Pericarditis But Not Clinically Significant | 9 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in ECG | LTE Week 24 | Abnormal-Not Consistent With Pericarditis But Clinically Significant | 0 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in ECG | LTE Baseline | Abnormal-Not Consistent With Pericarditis But Not Clinically Significant | 8 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in ECG | LTE Baseline | Abnormal-Not Consistent With Pericarditis But Clinically Significant | 0 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in ECG | LTE Baseline | Normal | 16 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in ECG | LTE Week 24 | Abnormal-Not Consistent With Pericarditis But Clinically Significant | 2 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in ECG | LTE Baseline | Abnormal-Not Consistent With Pericarditis But Clinically Significant | 1 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in ECG | LTE Baseline | Abnormal-Not Consistent With Pericarditis But Not Clinically Significant | 11 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in ECG | LTE Week 24 | Normal | 19 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in ECG | LTE Week 24 | Abnormal-Consistent With Pericarditis | 1 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in ECG | LTE Week 24 | Abnormal-Not Consistent With Pericarditis But Not Clinically Significant | 9 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in ECG | LTE Baseline | Normal | 21 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in ECG | LTE Baseline | Abnormal-Consistent With Pericarditis | 1 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in ECG | LTE Baseline | Abnormal-Not Consistent With Pericarditis But Clinically Significant | 1 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in ECG | LTE Baseline | Abnormal-Not Consistent With Pericarditis But Not Clinically Significant | 27 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in ECG | LTE Baseline | Abnormal-Consistent With Pericarditis | 2 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in ECG | LTE Baseline | Normal | 44 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in ECG | LTE Week 24 | Normal | 42 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in ECG | LTE Week 24 | Abnormal-Not Consistent With Pericarditis But Not Clinically Significant | 24 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in ECG | LTE Week 24 | Abnormal-Not Consistent With Pericarditis But Clinically Significant | 3 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in ECG | LTE Week 24 | Abnormal-Consistent With Pericarditis | 2 Participants |
Secondary
Change From LTE Baseline in Pericardial Signs in ECHO
Time frame: LTE Baseline, LTE Week 24
Population: Long term extension (LTE) Analysis Set: participants who consented to LTE period and took at least 1 dose of study drug in the LTE period. Participants 18 years or older with an assessment at given time point.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in ECHO | No Change | 3 Participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in ECHO | Resolved | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in ECHO | Missing | 3 Participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in ECHO | Not Applicable | 8 Participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in ECHO | Improving | 1 Participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in ECHO | New | 0 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in ECHO | Improving | 0 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in ECHO | Resolved | 1 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in ECHO | No Change | 4 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in ECHO | Not Applicable | 17 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in ECHO | New | 0 Participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in ECHO | Missing | 2 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in ECHO | Improving | 1 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in ECHO | No Change | 7 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in ECHO | New | 1 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in ECHO | Resolved | 1 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in ECHO | Missing | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in ECHO | Not Applicable | 14 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in ECHO | Not Applicable | 39 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in ECHO | Missing | 5 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in ECHO | New | 1 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in ECHO | Improving | 2 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in ECHO | No Change | 14 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in ECHO | Resolved | 2 Participants |
Secondary
Change From LTE Baseline in Pericardial Signs in MRI
Time frame: LTE Baseline, LTE Week 24
Population: LTE Analysis Set - Participants in MRI Substudy. The number analyzed on each row pertains to the number of participants with a given baseline status.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Myocardial Delayed Hyperenhancement Baseline Missing -> Week 24 Not Done | 4 participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Effusion Baseline Missing -> Week 24 No | 0 participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Effusion Baseline No -> Week 24 Not Done | 0 participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Delayed Hyperenhancement Baseline Missing -> Week 24 Not Done | 4 participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Delayed Hyperenhancement Baseline Yes -> Week 24 No | 1 participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Effusion Baseline Missing -> Week 24 Not Done | 4 participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Effusion Baseline Yes -> Week 24 No | 1 participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Myocardial Delayed Hyperenhancement Baseline Yes -> Week 24 Yes | 0 participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Myocardial Delayed Hyperenhancement Baseline Missing -> Week 24 No | 0 participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Delayed Hyperenhancement Baseline Yes -> Week 24 Not Done | 1 participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Effusion Baseline No -> Week 24 No | 3 participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Myocardial Delayed Hyperenhancement Baseline Yes -> Week 24 No | 1 participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Myocardial Delayed Hyperenhancement Baseline Missing -> Week 24 Yes | 0 participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Effusion Baseline Missing -> Week 24 Yes | 0 participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Delayed Hyperenhancement Baseline Missing -> Week 24 Yes | 0 participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Myocardial Delayed Hyperenhancement Baseline Yes -> Week 24 Not Done | 1 participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Myocardial Delayed Hyperenhancement Baseline No -> Week 24 Not Done | 0 participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Delayed Hyperenhancement Baseline Yes -> Week 24 Yes | 2 participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Effusion Baseline No -> Week 24 Yes | 0 participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Myocardial Delayed Hyperenhancement Baseline No -> Week 24 Yes | 0 participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Effusion Baseline Yes -> Week 24 Not Done | 0 participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Effusion Baseline Yes -> Week 24 Yes | 0 participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Delayed Hyperenhancement Baseline Missing -> Week 24 No | 0 participants |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Myocardial Delayed Hyperenhancement Baseline No -> Week 24 No | 2 participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in MRI | Myocardial Delayed Hyperenhancement Baseline No -> Week 24 Yes | 0 participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Effusion Baseline Missing -> Week 24 No | 1 participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Effusion Baseline Yes -> Week 24 Not Done | 0 participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Delayed Hyperenhancement Baseline Missing -> Week 24 Not Done | 1 participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Delayed Hyperenhancement Baseline No -> Week 24 Yes | 0 participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Effusion Baseline Yes -> Week 24 No | 1 participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in MRI | Myocardial Delayed Hyperenhancement Baseline No -> Week 24 Not Done | 3 participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Effusion Baseline Missing -> Week 24 Not Done | 1 participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in MRI | Myocardial Delayed Hyperenhancement Baseline Missing -> Week 24 Yes | 0 participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Effusion Baseline Yes -> Week 24 Yes | 0 participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in MRI | Myocardial Delayed Hyperenhancement Baseline Missing -> Week 24 No | 1 participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Delayed Hyperenhancement Baseline No -> Week 24 No | 1 participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in MRI | Myocardial Delayed Hyperenhancement Baseline Missing -> Week 24 Not Done | 1 participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Effusion Baseline Missing -> Week 24 Yes | 0 participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Delayed Hyperenhancement Baseline No -> Week 24 Not Done | 1 participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Delayed Hyperenhancement Baseline Yes -> Week 24 No | 1 participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Delayed Hyperenhancement Baseline Missing -> Week 24 Yes | 0 participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Effusion Baseline No -> Week 24 Not Done | 4 participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Delayed Hyperenhancement Baseline Missing -> Week 24 No | 1 participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Delayed Hyperenhancement Baseline Yes -> Week 24 Yes | 5 participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in MRI | Myocardial Delayed Hyperenhancement Baseline No -> Week 24 No | 6 participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Effusion Baseline No -> Week 24 No | 6 participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in MRI | Myocardial Delayed Hyperenhancement Baseline Yes -> Week 24 Yes | 0 participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in MRI | Myocardial Delayed Hyperenhancement Baseline Yes -> Week 24 No | 0 participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Delayed Hyperenhancement Baseline Yes -> Week 24 Not Done | 3 participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Effusion Baseline No -> Week 24 Yes | 0 participants |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in Pericardial Signs in MRI | Myocardial Delayed Hyperenhancement Baseline Yes -> Week 24 Not Done | 2 participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Delayed Hyperenhancement Baseline Missing -> Week 24 Yes | 0 participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Delayed Hyperenhancement Baseline Yes -> Week 24 Yes | 2 participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Delayed Hyperenhancement Baseline Yes -> Week 24 No | 0 participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Delayed Hyperenhancement Baseline Yes -> Week 24 Not Done | 8 participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Delayed Hyperenhancement Baseline No -> Week 24 Yes | 0 participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Delayed Hyperenhancement Baseline No -> Week 24 No | 2 participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Delayed Hyperenhancement Baseline No -> Week 24 Not Done | 2 participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Delayed Hyperenhancement Baseline Missing -> Week 24 No | 0 participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Delayed Hyperenhancement Baseline Missing -> Week 24 Not Done | 2 participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Myocardial Delayed Hyperenhancement Baseline Yes -> Week 24 Yes | 0 participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Myocardial Delayed Hyperenhancement Baseline Yes -> Week 24 No | 2 participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Myocardial Delayed Hyperenhancement Baseline Yes -> Week 24 Not Done | 1 participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Myocardial Delayed Hyperenhancement Baseline No -> Week 24 Yes | 1 participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Myocardial Delayed Hyperenhancement Baseline No -> Week 24 No | 1 participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Myocardial Delayed Hyperenhancement Baseline No -> Week 24 Not Done | 9 participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Myocardial Delayed Hyperenhancement Baseline Missing -> Week 24 Yes | 0 participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Myocardial Delayed Hyperenhancement Baseline Missing -> Week 24 No | 0 participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Myocardial Delayed Hyperenhancement Baseline Missing -> Week 24 Not Done | 2 participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Effusion Baseline No -> Week 24 Yes | 0 participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Effusion Baseline No -> Week 24 No | 4 participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Effusion Baseline No -> Week 24 Not Done | 10 participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Effusion Baseline Missing -> Week 24 Yes | 0 participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Effusion Baseline Missing -> Week 24 No | 0 participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Effusion Baseline Missing -> Week 24 Not Done | 2 participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Effusion Baseline Yes -> Week 24 No | 2 participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Myocardial Delayed Hyperenhancement Baseline No -> Week 24 Yes | 1 participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Effusion Baseline Yes -> Week 24 Not Done | 0 participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Myocardial Delayed Hyperenhancement Baseline Yes -> Week 24 Not Done | 4 participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Myocardial Delayed Hyperenhancement Baseline Yes -> Week 24 No | 3 participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Effusion Baseline Missing -> Week 24 Not Done | 7 participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Effusion Baseline No -> Week 24 Yes | 0 participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Myocardial Delayed Hyperenhancement Baseline Yes -> Week 24 Yes | 0 participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Delayed Hyperenhancement Baseline Missing -> Week 24 Not Done | 7 participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Effusion Baseline Missing -> Week 24 No | 1 participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Effusion Baseline No -> Week 24 No | 13 participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Delayed Hyperenhancement Baseline Missing -> Week 24 No | 1 participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Delayed Hyperenhancement Baseline Missing -> Week 24 Yes | 0 participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Delayed Hyperenhancement Baseline Yes -> Week 24 No | 2 participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Effusion Baseline No -> Week 24 Not Done | 14 participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Delayed Hyperenhancement Baseline No -> Week 24 Not Done | 3 participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Delayed Hyperenhancement Baseline No -> Week 24 No | 3 participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Delayed Hyperenhancement Baseline Yes -> Week 24 Yes | 9 participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Effusion Baseline Missing -> Week 24 Yes | 0 participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Delayed Hyperenhancement Baseline No -> Week 24 Yes | 0 participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Delayed Hyperenhancement Baseline Yes -> Week 24 Not Done | 12 participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Myocardial Delayed Hyperenhancement Baseline Missing -> Week 24 Not Done | 7 participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Myocardial Delayed Hyperenhancement Baseline Missing -> Week 24 No | 1 participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Myocardial Delayed Hyperenhancement Baseline Missing -> Week 24 Yes | 0 participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Pericardial Effusion Baseline Yes -> Week 24 Yes | 0 participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Myocardial Delayed Hyperenhancement Baseline No -> Week 24 Not Done | 12 participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in Pericardial Signs in MRI | Myocardial Delayed Hyperenhancement Baseline No -> Week 24 No | 9 participants |
Secondary
Change From LTE Baseline in SF-6D Health Utility Index Score
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).
Time frame: LTE Baseline, LTE Week 24
Population: Long term extension (LTE) Analysis Set: participants who consented to LTE period and took at least 1 dose of study drug in the LTE period. Participants with an assessment at given time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in SF-6D Health Utility Index Score | -0.106 score on a scale | Standard Deviation 0.4449 |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in SF-6D Health Utility Index Score | 0.163 score on a scale | Standard Deviation 0.4368 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in SF-6D Health Utility Index Score | 0.003 score on a scale | Standard Deviation 0.0781 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in SF-6D Health Utility Index Score | 0.035 score on a scale | Standard Deviation 0.3425 |
Secondary
Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores
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.
Time frame: LTE Baseline, LTE Week 24
Population: Long term extension (LTE) Analysis Set: participants who consented to LTE period and took at least 1 dose of study drug in the LTE period. Participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | Mental Health: Change at LTE Week 24 | 2.988 score on a scale | Standard Deviation 9.8321 |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | Role-Physical: Change at LTE Week 24 | -1.443 score on a scale | Standard Deviation 6.0141 |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | Vitality: Change at LTE Week 24 | 1.910 score on a scale | Standard Deviation 8.2069 |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | General Health: Change at LTE Week 24 | 1.324 score on a scale | Standard Deviation 10.1092 |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | Role-Emotional: Change at LTE Week 24 | 0.496 score on a scale | Standard Deviation 6.3849 |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | Physical Functioning: Change at LTE Week 24 | 2.596 score on a scale | Standard Deviation 8.4132 |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | Bodily Pain: Change at LTE Week 24 | 3.082 score on a scale | Standard Deviation 10.2083 |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | Mental Score: Change at LTE Week 24 | 1.186 score on a scale | Standard Deviation 7.5539 |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | Physical Score: Change at LTE Week 24 | 1.210 score on a scale | Standard Deviation 6.5951 |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | Social Functioning: Change at LTE Week 24 | -0.716 score on a scale | Standard Deviation 7.832 |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | Mental Health: Change at LTE Week 24 | 0.455 score on a scale | Standard Deviation 8.2976 |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | Physical Functioning: Change at LTE Week 24 | 0.125 score on a scale | Standard Deviation 6.4017 |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | Physical Score: Change at LTE Week 24 | 1.168 score on a scale | Standard Deviation 8.0082 |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | Mental Score: Change at LTE Week 24 | 0.596 score on a scale | Standard Deviation 6.6219 |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | Bodily Pain: Change at LTE Week 24 | 1.140 score on a scale | Standard Deviation 9.6306 |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | General Health: Change at LTE Week 24 | 0.932 score on a scale | Standard Deviation 7.0108 |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | Vitality: Change at LTE Week 24 | 1.679 score on a scale | Standard Deviation 9.3889 |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | Social Functioning: Change at LTE Week 24 | 0.219 score on a scale | Standard Deviation 10.0797 |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | Role-Physical: Change at LTE Week 24 | 2.052 score on a scale | Standard Deviation 9.8327 |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | Role-Emotional: Change at LTE Week 24 | 0.758 score on a scale | Standard Deviation 5.6497 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | Bodily Pain: Change at LTE Week 24 | -0.820 score on a scale | Standard Deviation 8.0536 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | Mental Score: Change at LTE Week 24 | 0.850 score on a scale | Standard Deviation 8.8099 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | Role-Emotional: Change at LTE Week 24 | -0.360 score on a scale | Standard Deviation 8.0771 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | Social Functioning: Change at LTE Week 24 | 0.172 score on a scale | Standard Deviation 6.4927 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | Role-Physical: Change at LTE Week 24 | -1.627 score on a scale | Standard Deviation 6.6 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | Physical Score: Change at LTE Week 24 | -1.079 score on a scale | Standard Deviation 6.317 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | General Health: Change at LTE Week 24 | 0.762 score on a scale | Standard Deviation 6.1724 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | Physical Functioning: Change at LTE Week 24 | -0.463 score on a scale | Standard Deviation 5.7067 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | Mental Health: Change at LTE Week 24 | 1.353 score on a scale | Standard Deviation 8.2616 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | Vitality: Change at LTE Week 24 | -0.307 score on a scale | Standard Deviation 6.6591 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | Vitality: Change at LTE Week 24 | 0.855 score on a scale | Standard Deviation 7.9681 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | Physical Functioning: Change at LTE Week 24 | 0.391 score on a scale | Standard Deviation 6.5919 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | Role-Physical: Change at LTE Week 24 | -0.306 score on a scale | Standard Deviation 7.8579 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | Bodily Pain: Change at LTE Week 24 | 0.690 score on a scale | Standard Deviation 9.0827 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | General Health: Change at LTE Week 24 | 0.940 score on a scale | Standard Deviation 7.3166 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | Mental Score: Change at LTE Week 24 | 0.833 score on a scale | Standard Deviation 7.7298 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | Social Functioning: Change at LTE Week 24 | 0.000 score on a scale | Standard Deviation 8.0595 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | Role-Emotional: Change at LTE Week 24 | 0.211 score on a scale | Standard Deviation 6.8796 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | Mental Health: Change at LTE Week 24 | 1.387 score on a scale | Standard Deviation 8.5381 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline in the SF-36 Domain Scores and Physical and Mental Scores | Physical Score: Change at LTE Week 24 | 0.190 score on a scale | Standard Deviation 6.9912 |
Secondary
Change From LTE Baseline Over Time in CRP Levels
Time frame: LTE Baseline, LTE Week 12, LTE Week 24
Population: Long term extension (LTE) Analysis Set: participants who consented to LTE period and took at least 1 dose of study drug in the LTE period. Participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline Over Time in CRP Levels | Change at Week 12 | 0.01 mg/dL | Standard Deviation 0.249 |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline Over Time in CRP Levels | Change at Week 24 | 0.03 mg/dL | Standard Deviation 0.182 |
| Randomized Withdrawal Period: Rilonacept | Change From LTE Baseline Over Time in CRP Levels | LTE Baseline | 0.18 mg/dL | Standard Deviation 0.294 |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline Over Time in CRP Levels | LTE Baseline | 0.21 mg/dL | Standard Deviation 0.249 |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline Over Time in CRP Levels | Change at Week 24 | 0.17 mg/dL | Standard Deviation 0.909 |
| Randomized Withdrawal Period: Placebo | Change From LTE Baseline Over Time in CRP Levels | Change at Week 12 | 0.00 mg/dL | Standard Deviation 0.127 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline Over Time in CRP Levels | Change at Week 12 | -0.06 mg/dL | Standard Deviation 0.255 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline Over Time in CRP Levels | LTE Baseline | 0.16 mg/dL | Standard Deviation 0.251 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From LTE Baseline Over Time in CRP Levels | Change at Week 24 | -0.06 mg/dL | Standard Deviation 0.269 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline Over Time in CRP Levels | LTE Baseline | 0.18 mg/dL | Standard Deviation 0.257 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline Over Time in CRP Levels | Change at Week 24 | 0.04 mg/dL | Standard Deviation 0.579 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From LTE Baseline Over Time in CRP Levels | Change at Week 12 | -0.03 mg/dL | Standard Deviation 0.219 |
Secondary
Change From RI Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value at RI Period Week 12
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.
Time frame: RI Period Baseline, RI Period Week 12
Population: Run-in Analysis Set: All participants who received at least 1 dose of study drug in the RI period. Participants with an assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Change From RI Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value at RI Period Week 12 | Self-Care | -0.1 score on a scale | Standard Deviation 0.57 |
| Randomized Withdrawal Period: Rilonacept | Change From RI Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value at RI Period Week 12 | Mobility | -0.2 score on a scale | Standard Deviation 0.84 |
| Randomized Withdrawal Period: Rilonacept | Change From RI Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value at RI Period Week 12 | Usual Activities | -1.1 score on a scale | Standard Deviation 1.16 |
| Randomized Withdrawal Period: Rilonacept | Change From RI Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value at RI Period Week 12 | Pain/Discomfort | -1.5 score on a scale | Standard Deviation 1.18 |
| Randomized Withdrawal Period: Rilonacept | Change From RI Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value at RI Period Week 12 | Anxiety/Depression | -0.5 score on a scale | Standard Deviation 0.9 |
| Randomized Withdrawal Period: Rilonacept | Change From RI Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value at RI Period Week 12 | Index Score | 0.1626 score on a scale | Standard Deviation 0.16814 |
| Randomized Withdrawal Period: Rilonacept | Change From RI Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value at RI Period Week 12 | VAS Score | 23.0 score on a scale | Standard Deviation 23.41 |
Secondary
Change From RI Period Baseline in ISI Total Score at RI Period Week 12
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).
Time frame: RI Period Baseline, RI Period Week 12
Population: Run-in Analysis Set: All participants who received at least 1 dose of study drug in the RI period. Participants with an assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Change From RI Period Baseline in ISI Total Score at RI Period Week 12 | -4.9 score on a scale | Standard Deviation 6.31 |
Secondary
Change From RI Period Baseline in SF-6D Scores at RI Period Week 12
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).
Time frame: RI Period Baseline, RI Period Week 12
Population: Run-in Analysis Set: All participants who received at least 1 dose of study drug in the RI period. Participants with an assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Change From RI Period Baseline in SF-6D Scores at RI Period Week 12 | 0.1828 score on a scale | Standard Deviation 0.12658 |
Secondary
Change From RI Period Baseline in the SF-36 Domain Scores and Physical and Mental Scores to RI Period Week 12
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.
Time frame: RI Period Baseline, RI Period Week 12
Population: Run-in Analysis Set: All participants who received at least 1 dose of study drug in the RI period. Participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Change From RI Period Baseline in the SF-36 Domain Scores and Physical and Mental Scores to RI Period Week 12 | Physical Component Score | 13.8 score on a scale | Standard Deviation 8.7 |
| Randomized Withdrawal Period: Rilonacept | Change From RI Period Baseline in the SF-36 Domain Scores and Physical and Mental Scores to RI Period Week 12 | Mental Component Score | 9.2 score on a scale | Standard Deviation 9.3 |
| Randomized Withdrawal Period: Rilonacept | Change From RI Period Baseline in the SF-36 Domain Scores and Physical and Mental Scores to RI Period Week 12 | Physical Functioning | 10.1 score on a scale | Standard Deviation 9.2 |
| Randomized Withdrawal Period: Rilonacept | Change From RI Period Baseline in the SF-36 Domain Scores and Physical and Mental Scores to RI Period Week 12 | Role-Physical | 13.8 score on a scale | Standard Deviation 9.4 |
| Randomized Withdrawal Period: Rilonacept | Change From RI Period Baseline in the SF-36 Domain Scores and Physical and Mental Scores to RI Period Week 12 | Bodily Pain | 19.1 score on a scale | Standard Deviation 10.3 |
| Randomized Withdrawal Period: Rilonacept | Change From RI Period Baseline in the SF-36 Domain Scores and Physical and Mental Scores to RI Period Week 12 | General Health | 7.7 score on a scale | Standard Deviation 8.2 |
| Randomized Withdrawal Period: Rilonacept | Change From RI Period Baseline in the SF-36 Domain Scores and Physical and Mental Scores to RI Period Week 12 | Vitality | 13.4 score on a scale | Standard Deviation 9.9 |
| Randomized Withdrawal Period: Rilonacept | Change From RI Period Baseline in the SF-36 Domain Scores and Physical and Mental Scores to RI Period Week 12 | Social Functioning | 15.1 score on a scale | Standard Deviation 10.6 |
| Randomized Withdrawal Period: Rilonacept | Change From RI Period Baseline in the SF-36 Domain Scores and Physical and Mental Scores to RI Period Week 12 | Role-Emotional | 7.7 score on a scale | Standard Deviation 10 |
| Randomized Withdrawal Period: Rilonacept | Change From RI Period Baseline in the SF-36 Domain Scores and Physical and Mental Scores to RI Period Week 12 | Mental Health | 9.6 score on a scale | Standard Deviation 9 |
Secondary
Change From RW Baseline in SF-36 Individual Scores at RW Period Week 24
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.
Time frame: RW Period Baseline, RW Period Week 24
Population: ITT Analysis Set: all participants who were randomized in the RW period. Participants 18 years and older with a non-missing value at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Change From RW Baseline in SF-36 Individual Scores at RW Period Week 24 | Change at RW Week 24 in Physical Functioning | 2.427 score on a scale | Standard Deviation 5.3887 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Baseline in SF-36 Individual Scores at RW Period Week 24 | Change at RW Week 24 in Role Physical | 2.995 score on a scale | Standard Deviation 5.7997 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Baseline in SF-36 Individual Scores at RW Period Week 24 | Change at RW Week 24 in Bodily Pain | -0.485 score on a scale | Standard Deviation 9.7799 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Baseline in SF-36 Individual Scores at RW Period Week 24 | Change at RW Week 24 in General Health | -0.919 score on a scale | Standard Deviation 4.9051 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Baseline in SF-36 Individual Scores at RW Period Week 24 | Change at RW Week 24 in Vitality | 3.168 score on a scale | Standard Deviation 9.8845 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Baseline in SF-36 Individual Scores at RW Period Week 24 | Change at RW Week 24 in Social Functioning | 0.669 score on a scale | Standard Deviation 8.6544 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Baseline in SF-36 Individual Scores at RW Period Week 24 | Change at RW Week 24 in Role Emotional | 3.251 score on a scale | Standard Deviation 10.7297 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Baseline in SF-36 Individual Scores at RW Period Week 24 | Change at RW Week 24 in Mental Health | 3.314 score on a scale | Standard Deviation 8.59 |
| Randomized Withdrawal Period: Placebo | Change From RW Baseline in SF-36 Individual Scores at RW Period Week 24 | Change at RW Week 24 in Social Functioning | 0.669 score on a scale | Standard Deviation 8.6544 |
| Randomized Withdrawal Period: Placebo | Change From RW Baseline in SF-36 Individual Scores at RW Period Week 24 | Change at RW Week 24 in Vitality | 3.168 score on a scale | Standard Deviation 9.8845 |
| Randomized Withdrawal Period: Placebo | Change From RW Baseline in SF-36 Individual Scores at RW Period Week 24 | Change at RW Week 24 in Role Physical | 2.995 score on a scale | Standard Deviation 5.7997 |
| Randomized Withdrawal Period: Placebo | Change From RW Baseline in SF-36 Individual Scores at RW Period Week 24 | Change at RW Week 24 in Mental Health | 3.314 score on a scale | Standard Deviation 8.59 |
| Randomized Withdrawal Period: Placebo | Change From RW Baseline in SF-36 Individual Scores at RW Period Week 24 | Change at RW Week 24 in Role Emotional | 3.251 score on a scale | Standard Deviation 10.7297 |
| Randomized Withdrawal Period: Placebo | Change From RW Baseline in SF-36 Individual Scores at RW Period Week 24 | Change at RW Week 24 in General Health | -0.919 score on a scale | Standard Deviation 4.9051 |
| Randomized Withdrawal Period: Placebo | Change From RW Baseline in SF-36 Individual Scores at RW Period Week 24 | Change at RW Week 24 in Bodily Pain | -0.485 score on a scale | Standard Deviation 9.7799 |
| Randomized Withdrawal Period: Placebo | Change From RW Baseline in SF-36 Individual Scores at RW Period Week 24 | Change at RW Week 24 in Physical Functioning | 2.427 score on a scale | Standard Deviation 5.3887 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Baseline in SF-36 Individual Scores at RW Period Week 24 | Change at RW Week 24 in Role Emotional | 0.000 score on a scale | Standard Deviation 0 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Baseline in SF-36 Individual Scores at RW Period Week 24 | Change at RW Week 24 in Bodily Pain | 0.807 score on a scale | Standard Deviation 5.2864 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Baseline in SF-36 Individual Scores at RW Period Week 24 | Change at RW Week 24 in General Health | -1.587 score on a scale | Standard Deviation 5.9895 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Baseline in SF-36 Individual Scores at RW Period Week 24 | Change at RW Week 24 in Vitality | 1.980 score on a scale | Standard Deviation 6.8589 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Baseline in SF-36 Individual Scores at RW Period Week 24 | Change at RW Week 24 in Social Functioning | 0.000 score on a scale | Standard Deviation 0 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Baseline in SF-36 Individual Scores at RW Period Week 24 | Change at RW Week 24 in Mental Health | -0.873 score on a scale | Standard Deviation 3.9923 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Baseline in SF-36 Individual Scores at RW Period Week 24 | Change at RW Week 24 in Physical Functioning | -0.637 score on a scale | Standard Deviation 1.1027 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Baseline in SF-36 Individual Scores at RW Period Week 24 | Change at RW Week 24 in Role Physical | 1.500 score on a scale | Standard Deviation 2.5981 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Baseline in SF-36 Individual Scores at RW Period Week 24 | Change at RW Week 24 in Bodily Pain | 0.921 score on a scale | Standard Deviation 6.2063 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Baseline in SF-36 Individual Scores at RW Period Week 24 | Change at RW Week 24 in General Health | -1.901 score on a scale | Standard Deviation 6.807 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Baseline in SF-36 Individual Scores at RW Period Week 24 | Change at RW Week 24 in Role Physical | 1.123 score on a scale | Standard Deviation 3.4967 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Baseline in SF-36 Individual Scores at RW Period Week 24 | Change at RW Week 24 in Physical Functioning | 0.273 score on a scale | Standard Deviation 4.0332 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Baseline in SF-36 Individual Scores at RW Period Week 24 | Change at RW Week 24 in Vitality | 0.636 score on a scale | Standard Deviation 6.185 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Baseline in SF-36 Individual Scores at RW Period Week 24 | Change at RW Week 24 in Mental Health | -0.187 score on a scale | Standard Deviation 6.7646 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Baseline in SF-36 Individual Scores at RW Period Week 24 | Change at RW Week 24 in Role Emotional | 0.249 score on a scale | Standard Deviation 7.0264 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Baseline in SF-36 Individual Scores at RW Period Week 24 | Change at RW Week 24 in Social Functioning | -1.791 score on a scale | Standard Deviation 4.2209 |
Secondary
Change From RW Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value to RW Period Week 24
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.
Time frame: RW Period Baseline, RW Period Week 24
Population: ITT Analysis Set: all participants who were randomized in the RW period. Participants 18 years and older with a non-missing value at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value to RW Period Week 24 | Change at RW Week 24 in Self-Care | -0.1 score on a scale | Standard Deviation 0.26 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value to RW Period Week 24 | Change at RW Week 24 in Index Score | 0.0033 score on a scale | Standard Deviation 0.09812 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value to RW Period Week 24 | Change at RW Week 24 in Usual Activities | -0.1 score on a scale | Standard Deviation 0.7 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value to RW Period Week 24 | Change at RW Week 24 in Mobility | -0.1 score on a scale | Standard Deviation 0.52 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value to RW Period Week 24 | Change at RW Week 24 in VAS Score | 7.5 score on a scale | Standard Deviation 17.32 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value to RW Period Week 24 | Change at RW Week 24 in Anxiety/Depression | -0.1 score on a scale | Standard Deviation 0.83 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value to RW Period Week 24 | Change at RW Week 24 in Pain/Discomfort | 0.1 score on a scale | Standard Deviation 0.92 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value to RW Period Week 24 | Change at RW Week 24 in Usual Activities | -0.1 score on a scale | Standard Deviation 0.7 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value to RW Period Week 24 | Change at RW Week 24 in Mobility | -0.1 score on a scale | Standard Deviation 0.52 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value to RW Period Week 24 | Change at RW Week 24 in Self-Care | -0.1 score on a scale | Standard Deviation 0.26 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value to RW Period Week 24 | Change at RW Week 24 in Pain/Discomfort | 0.1 score on a scale | Standard Deviation 0.92 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value to RW Period Week 24 | Change at RW Week 24 in Anxiety/Depression | -0.1 score on a scale | Standard Deviation 0.83 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value to RW Period Week 24 | Change at RW Week 24 in Index Score | 0.0033 score on a scale | Standard Deviation 0.09812 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value to RW Period Week 24 | Change at RW Week 24 in VAS Score | 7.5 score on a scale | Standard Deviation 17.32 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value to RW Period Week 24 | Change at RW Week 24 in VAS Score | 10.0 score on a scale | Standard Deviation 10.15 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value to RW Period Week 24 | Change at RW Week 24 in Index Score | 0.0413 score on a scale | Standard Deviation 0.15635 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value to RW Period Week 24 | Change at RW Week 24 in Anxiety/Depression | -0.3 score on a scale | Standard Deviation 0.58 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value to RW Period Week 24 | Change at RW Week 24 in Mobility | 0.0 score on a scale | Standard Deviation 0 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value to RW Period Week 24 | Change at RW Week 24 in Self-Care | 0.0 score on a scale | Standard Deviation 0 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value to RW Period Week 24 | Change at RW Week 24 in Usual Activities | 0.0 score on a scale | Standard Deviation 0 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value to RW Period Week 24 | Change at RW Week 24 in Pain/Discomfort | 0.0 score on a scale | Standard Deviation 1 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value to RW Period Week 24 | Change at RW Week 24 in Usual Activities | 0.1 score on a scale | Standard Deviation 0.36 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value to RW Period Week 24 | Change at RW Week 24 in Pain/Discomfort | 0.1 score on a scale | Standard Deviation 0.47 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value to RW Period Week 24 | Change at RW Week 24 in VAS Score | -8.3 score on a scale | Standard Deviation 29.07 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value to RW Period Week 24 | Change at RW Week 24 in Anxiety/Depression | 0.0 score on a scale | Standard Deviation 0.55 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value to RW Period Week 24 | Change at RW Week 24 in Index Score | 0.0029 score on a scale | Standard Deviation 0.08592 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value to RW Period Week 24 | Change at RW Week 24 in Self-Care | 0.1 score on a scale | Standard Deviation 0.27 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline in 5-level EuroQoL-5 Dimensions (EQ-5D-5L) Individual Scores and Index Value to RW Period Week 24 | Change at RW Week 24 in Mobility | -0.1 score on a scale | Standard Deviation 0.53 |
Secondary
Change From RW Period Baseline in Insomnia Severity Index (ISI) Total Score at RW Period Week 24
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).
Time frame: RW Period Baseline, RW Period Week 24
Population: ITT Analysis Set: all participants who were randomized in the RW period. Participants 18 years and older with a non-missing value at given time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline in Insomnia Severity Index (ISI) Total Score at RW Period Week 24 | -0.7 score on a scale | Standard Deviation 4.75 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline in Insomnia Severity Index (ISI) Total Score at RW Period Week 24 | -0.7 score on a scale | Standard Deviation 4.75 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline in Insomnia Severity Index (ISI) Total Score at RW Period Week 24 | -0.3 score on a scale | Standard Deviation 3.79 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline in Insomnia Severity Index (ISI) Total Score at RW Period Week 24 | -0.2 score on a scale | Standard Deviation 2.99 |
Secondary
Change From RW Period Baseline in Short Form-36 (SF-36) Physical and Mental Component Scores at RW Period Week 24
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.
Time frame: RW Period Baseline, RW Period Week 24
Population: ITT Analysis Set: all participants who were randomized in the RW period. Participants 18 years and older with a non-missing value at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline in Short Form-36 (SF-36) Physical and Mental Component Scores at RW Period Week 24 | Change at RW Week 24 in PCS | 0.427 score on a scale | Standard Deviation 5.8566 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline in Short Form-36 (SF-36) Physical and Mental Component Scores at RW Period Week 24 | Change at RW Week 24 in MCS | 3.081 score on a scale | Standard Deviation 11.3204 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline in Short Form-36 (SF-36) Physical and Mental Component Scores at RW Period Week 24 | Change at RW Week 24 in MCS | 3.081 score on a scale | Standard Deviation 11.3204 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline in Short Form-36 (SF-36) Physical and Mental Component Scores at RW Period Week 24 | Change at RW Week 24 in PCS | 0.427 score on a scale | Standard Deviation 5.8566 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline in Short Form-36 (SF-36) Physical and Mental Component Scores at RW Period Week 24 | Change at RW Week 24 in PCS | 0.363 score on a scale | Standard Deviation 2.3866 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline in Short Form-36 (SF-36) Physical and Mental Component Scores at RW Period Week 24 | Change at RW Week 24 in MCS | -0.050 score on a scale | Standard Deviation 2.7318 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline in Short Form-36 (SF-36) Physical and Mental Component Scores at RW Period Week 24 | Change at RW Week 24 in PCS | 0.354 score on a scale | Standard Deviation 2.7169 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline in Short Form-36 (SF-36) Physical and Mental Component Scores at RW Period Week 24 | Change at RW Week 24 in MCS | -0.575 score on a scale | Standard Deviation 5.5922 |
Secondary
Change From RW Period Baseline in the Short Form Health Survey-6 Domains (SF-6D) Utility Index Score at RW Period Week 24
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).
Time frame: RW Period Baseline, RW Period Week 24
Population: ITT Analysis Set: all participants who were randomized in the RW period. Participants 18 years and older with a non-missing value at given time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline in the Short Form Health Survey-6 Domains (SF-6D) Utility Index Score at RW Period Week 24 | 0.0385 score on a scale | Standard Deviation 0.10879 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline in the Short Form Health Survey-6 Domains (SF-6D) Utility Index Score at RW Period Week 24 | 0.0385 score on a scale | Standard Deviation 0.10879 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline in the Short Form Health Survey-6 Domains (SF-6D) Utility Index Score at RW Period Week 24 | -0.0027 score on a scale | Standard Deviation 0.05705 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline in the Short Form Health Survey-6 Domains (SF-6D) Utility Index Score at RW Period Week 24 | -0.0005 score on a scale | Standard Deviation 0.09871 |
Secondary
Change From RW Period Baseline Over Time in CRP Levels in RW Period
Estimated from ANCOVA models including treatment arm as fix effect, baseline value, baseline value by treatment interaction, randomization strata as covariates.
Time frame: RW Period Baseline, RW Period Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 56
Population: ITT Analysis Set: all participants who were randomized in the RW period. Participants with a non-missing value at given time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in CRP Levels in RW Period | Change at RW Week 32 | -0.05 mg/dL | Standard Error 0.016 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in CRP Levels in RW Period | Change at RW Week 24 | -0.04 mg/dL | Standard Error 0.032 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in CRP Levels in RW Period | Change at RW Week 48 | 0.02 mg/dL | Standard Error 0 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in CRP Levels in RW Period | Change at RW Week 16 | 0.40 mg/dL | Standard Error 0.148 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in CRP Levels in RW Period | Change at RW Week 12 | 0.04 mg/dL | Standard Error 0.034 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in CRP Levels in RW Period | Change at RW Week 8 | 0.12 mg/dL | Standard Error 0.308 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in CRP Levels in RW Period | Change at RW Week 40 | 0.04 mg/dL | Standard Error 0.01 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in CRP Levels in RW Period | Change at RW Week 20 | -0.04 mg/dL | Standard Error 0.048 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in CRP Levels in RW Period | Change at RW Week 4 | -0.01 mg/dL | Standard Error 0.058 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in CRP Levels in RW Period | Change at RW Week 20 | -0.10 mg/dL | Standard Error 0.181 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in CRP Levels in RW Period | Change at RW Week 32 | -0.02 mg/dL | Standard Error 0.059 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in CRP Levels in RW Period | Change at RW Week 24 | -0.05 mg/dL | Standard Error 0.047 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in CRP Levels in RW Period | Change at RW Week 8 | 0.11 mg/dL | Standard Error 0.3 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in CRP Levels in RW Period | Change at RW Week 4 | -0.05 mg/dL | Standard Error 1.112 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in CRP Levels in RW Period | Change at RW Week 12 | -0.04 mg/dL | Standard Error 0.085 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in CRP Levels in RW Period | Change at RW Week 48 | -0.03 mg/dL | Standard Error 0.008 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in CRP Levels in RW Period | Change at RW Week 40 | 0.08 mg/dL | Standard Error 0.298 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in CRP Levels in RW Period | Change at RW Week 16 | 0.27 mg/dL | Standard Error 0.119 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in CRP Levels in RW Period | Change at RW Week 20 | 0.10 mg/dL | Standard Error 0.083 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in CRP Levels in RW Period | Change at RW Week 4 | 0.15 mg/dL | Standard Error 0.061 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in CRP Levels in RW Period | Change at RW Week 8 | 0.45 mg/dL | Standard Error 0.331 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in CRP Levels in RW Period | Change at RW Week 12 | 0.03 mg/dL | Standard Error 0.043 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in CRP Levels in RW Period | Change at RW Week 16 | 0.04 mg/dL | Standard Error 0.227 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in CRP Levels in RW Period | Change at RW Week 24 | 0.06 mg/dL | Standard Error 0.056 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in CRP Levels in RW Period | Change at RW Week 32 | NA mg/dL | — |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in CRP Levels in RW Period | Change at RW Week 40 | NA mg/dL | — |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in CRP Levels in RW Period | Change at RW Week 48 | 0.06 mg/dL | Standard Error 0.017 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in CRP Levels in RW Period | Change at RW Week 32 | 0.07 mg/dL | Standard Error 0.055 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in CRP Levels in RW Period | Change at RW Week 16 | 0.18 mg/dL | Standard Error 0.109 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in CRP Levels in RW Period | Change at RW Week 12 | 0.08 mg/dL | Standard Error 0.077 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in CRP Levels in RW Period | Change at RW Week 56 | 0.00 mg/dL | — |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in CRP Levels in RW Period | Change at RW Week 40 | 0.74 mg/dL | Standard Error 0.29 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in CRP Levels in RW Period | Change at RW Week 8 | 0.25 mg/dL | Standard Error 0.246 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in CRP Levels in RW Period | Change at RW Week 4 | 1.46 mg/dL | Standard Error 0.861 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in CRP Levels in RW Period | Change at RW Week 24 | 0.02 mg/dL | Standard Error 0.045 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in CRP Levels in RW Period | Change at RW Week 20 | 0.16 mg/dL | Standard Error 0.174 |
Secondary
Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period
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.
Time frame: RW Period Baseline, RW Period Weeks 1-50, 54
Population: ITT Analysis Set: all participants who were randomized in the RW period. Participants with a non-missing value at given time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 2 | -0.21 units on a scale | Standard Error 0.237 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 1 | -0.08 units on a scale | Standard Error 0.103 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 18 | 0.13 units on a scale | Standard Error 0.149 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 50 | 0.00 units on a scale | — |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 15 | 0.32 units on a scale | Standard Error 0.109 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 39 | 0.96 units on a scale | Standard Error 0.26 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 9 | -0.24 units on a scale | Standard Error 0.31 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 27 | 0.23 units on a scale | Standard Error 0.193 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 37 | -0.02 units on a scale | Standard Error 0.243 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 40 | NA units on a scale | — |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 35 | 0.75 units on a scale | Standard Error 0.055 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 41 | 0.92 units on a scale | Standard Error 0.293 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 19 | 0.04 units on a scale | Standard Error 0.149 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 49 | -0.50 units on a scale | Standard Error 0 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 42 | 0.77 units on a scale | Standard Error 0.488 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 14 | 0.14 units on a scale | Standard Error 0.186 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 38 | 0.56 units on a scale | Standard Error 0.022 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 43 | 1.03 units on a scale | Standard Error 0.619 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 8 | 0.10 units on a scale | Standard Error 0.226 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 34 | 1.64 units on a scale | Standard Error 0.086 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 44 | 0.84 units on a scale | Standard Error 0.553 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 20 | -0.08 units on a scale | Standard Error 0.111 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 48 | 0.03 units on a scale | Standard Error 0 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 45 | 0.77 units on a scale | Standard Error 0.567 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 12 | 0.07 units on a scale | Standard Error 0.174 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 7 | 0.06 units on a scale | Standard Error 0.273 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 46 | 0.18 units on a scale | Standard Error 0.68 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 16 | 0.12 units on a scale | Standard Error 0.11 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 21 | 0.04 units on a scale | Standard Error 0.156 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 47 | 0.07 units on a scale | Standard Error 0 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 13 | -0.02 units on a scale | Standard Error 0.331 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 29 | 0.26 units on a scale | Standard Error 0.16 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 6 | 0.22 units on a scale | Standard Error 0.296 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 22 | -0.08 units on a scale | Standard Error 0.097 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 11 | -0.20 units on a scale | Standard Error 0.2 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 5 | -0.16 units on a scale | Standard Error 0.314 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 30 | 0.25 units on a scale | Standard Error 0.296 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 23 | -0.01 units on a scale | Standard Error 0.103 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 17 | 0.19 units on a scale | Standard Error 0.129 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 28 | 0.38 units on a scale | Standard Error 0.449 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 4 | -0.16 units on a scale | Standard Error 0.322 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 24 | 0.02 units on a scale | Standard Error 0.122 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 31 | 0.06 units on a scale | Standard Error 0.11 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 33 | 0.62 units on a scale | Standard Error 0.016 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 36 | 0.25 units on a scale | Standard Error 0.093 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 25 | 0.12 units on a scale | Standard Error 0.122 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 10 | -0.17 units on a scale | Standard Error 0.27 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 3 | -0.08 units on a scale | Standard Error 0.296 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 32 | 0.47 units on a scale | Standard Error 0.081 |
| Randomized Withdrawal Period: Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 26 | 0.19 units on a scale | Standard Error 0.145 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 13 | 0.06 units on a scale | Standard Error 0.256 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 31 | 0.02 units on a scale | Standard Error 0.109 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 14 | 0.08 units on a scale | Standard Error 0.185 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 15 | 0.19 units on a scale | Standard Error 0.149 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 16 | -0.07 units on a scale | Standard Error 0.167 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 17 | 0.01 units on a scale | Standard Error 0.183 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 18 | 0.05 units on a scale | Standard Error 0.157 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 19 | -0.05 units on a scale | Standard Error 0.167 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 20 | -0.22 units on a scale | Standard Error 0.228 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 34 | 0.95 units on a scale | Standard Error 0.387 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 21 | 0.02 units on a scale | Standard Error 0.162 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 22 | -0.12 units on a scale | Standard Error 0.124 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 35 | 0.62 units on a scale | Standard Error 0.347 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 23 | -0.03 units on a scale | Standard Error 0.145 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 24 | -0.04 units on a scale | Standard Error 0.138 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 25 | 0.09 units on a scale | Standard Error 0.109 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 36 | 0.15 units on a scale | Standard Error 0.348 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 38 | 0.40 units on a scale | Standard Error 0.177 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 30 | 0.39 units on a scale | Standard Error 0.259 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 39 | 0.55 units on a scale | Standard Error 0.578 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 37 | -0.13 units on a scale | Standard Error 0.404 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 41 | 0.72 units on a scale | Standard Error 0.723 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 42 | 0.79 units on a scale | Standard Error 0.262 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 43 | 0.87 units on a scale | Standard Error 0.449 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 40 | 0.17 units on a scale | Standard Error 1.253 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 44 | 0.64 units on a scale | Standard Error 0.59 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 45 | 0.85 units on a scale | Standard Error 0.384 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 32 | 0.20 units on a scale | Standard Error 0.141 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 46 | 0.39 units on a scale | Standard Error 0.471 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 26 | 0.16 units on a scale | Standard Error 0.127 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 47 | 0.16 units on a scale | Standard Error 0.261 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 48 | 0.32 units on a scale | Standard Error 0.273 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 49 | -0.13 units on a scale | Standard Error 0.115 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 50 | 0.00 units on a scale | — |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 1 | -0.08 units on a scale | Standard Error 0.103 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 27 | 0.16 units on a scale | Standard Error 0.154 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 2 | -0.25 units on a scale | Standard Error 0.273 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 3 | -0.15 units on a scale | Standard Error 0.33 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 4 | -0.11 units on a scale | Standard Error 0.468 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 5 | -0.21 units on a scale | Standard Error 0.351 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 10 | -0.21 units on a scale | Standard Error 0.262 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 28 | 0.33 units on a scale | Standard Error 0.339 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 6 | 0.02 units on a scale | Standard Error 0.31 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 7 | 0.12 units on a scale | Standard Error 0.248 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 29 | 0.29 units on a scale | Standard Error 0.233 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 8 | 0.11 units on a scale | Standard Error 0.205 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 9 | 0.05 units on a scale | Standard Error 0.32 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 33 | 0.31 units on a scale | Standard Error 0.167 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 11 | -0.16 units on a scale | Standard Error 0.272 |
| Randomized Withdrawal Period: Placebo | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 12 | -0.03 units on a scale | Standard Error 0.248 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 3 | 1.12 units on a scale | Standard Error 0.278 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 24 | NA units on a scale | — |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 35 | NA units on a scale | — |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 10 | 1.11 units on a scale | Standard Error 0.343 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 4 | 1.05 units on a scale | Standard Error 0.333 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 23 | NA units on a scale | — |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 22 | NA units on a scale | — |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 28 | NA units on a scale | — |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 5 | 1.27 units on a scale | Standard Error 0.332 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 16 | NA units on a scale | — |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 14 | 0.24 units on a scale | Standard Error 0.262 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 34 | NA units on a scale | — |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 11 | 0.43 units on a scale | Standard Error 0.267 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 6 | 0.96 units on a scale | Standard Error 0.29 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 21 | NA units on a scale | — |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 20 | NA units on a scale | — |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 33 | NA units on a scale | — |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 7 | 0.87 units on a scale | Standard Error 0.304 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 15 | -0.08 units on a scale | Standard Error 0.235 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 19 | NA units on a scale | — |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 13 | 0.25 units on a scale | Standard Error 0.386 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 26 | NA units on a scale | — |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 40 | NA units on a scale | — |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 8 | 0.77 units on a scale | Standard Error 0.253 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 32 | NA units on a scale | — |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 30 | NA units on a scale | — |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 29 | NA units on a scale | — |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 39 | NA units on a scale | — |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 38 | NA units on a scale | — |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 18 | NA units on a scale | — |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 37 | NA units on a scale | — |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 12 | 0.36 units on a scale | Standard Error 0.235 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 1 | 0.17 units on a scale | Standard Error 0.099 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 9 | 1.45 units on a scale | Standard Error 0.402 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 36 | NA units on a scale | — |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 31 | NA units on a scale | — |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 2 | 0.57 units on a scale | Standard Error 0.231 |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 27 | NA units on a scale | — |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 25 | NA units on a scale | — |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 17 | NA units on a scale | — |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 7 | 0.86 units on a scale | Standard Error 0.224 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 28 | 0.18 units on a scale | Standard Error 0.34 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 33 | 0.20 units on a scale | Standard Error 0.151 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 36 | 0.20 units on a scale | Standard Error 0.346 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 37 | 0.16 units on a scale | Standard Error 0.367 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 54 | 0.58 units on a scale | Standard Error 0 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 26 | 0.29 units on a scale | Standard Error 0.131 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 27 | 0.15 units on a scale | Standard Error 0.157 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 29 | 0.12 units on a scale | Standard Error 0.227 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 30 | 0.64 units on a scale | Standard Error 0.25 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 31 | 0.33 units on a scale | Standard Error 0.105 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 32 | 0.23 units on a scale | Standard Error 0.118 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 34 | 0.27 units on a scale | Standard Error 0.329 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 35 | 0.11 units on a scale | Standard Error 0.295 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 38 | 0.04 units on a scale | Standard Error 0.162 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 39 | 0.51 units on a scale | Standard Error 0.592 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 40 | 0.44 units on a scale | Standard Error 1.002 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 41 | 0.91 units on a scale | Standard Error 0.939 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 42 | 0.60 units on a scale | Standard Error 0.342 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 43 | 0.88 units on a scale | Standard Error 0.587 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 44 | 0.75 units on a scale | Standard Error 0.766 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 45 | 3.77 units on a scale | Standard Error 1.564 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 46 | NA units on a scale | — |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 47 | 3.10 units on a scale | Standard Error 1.07 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 48 | 6.18 units on a scale | Standard Error 1.49 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 49 | 5.77 units on a scale | Standard Error 0.63 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 1 | 0.17 units on a scale | Standard Error 0.099 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 2 | 0.68 units on a scale | Standard Error 0.263 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 3 | 1.29 units on a scale | Standard Error 0.302 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 4 | 1.84 units on a scale | Standard Error 0.428 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 5 | 1.34 units on a scale | Standard Error 0.32 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 6 | 0.84 units on a scale | Standard Error 0.265 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 15 | 0.15 units on a scale | Standard Error 0.136 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 8 | 0.58 units on a scale | Standard Error 0.189 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 9 | 1.10 units on a scale | Standard Error 0.301 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 10 | 0.62 units on a scale | Standard Error 0.24 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 11 | 0.46 units on a scale | Standard Error 0.25 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 12 | 0.32 units on a scale | Standard Error 0.225 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 13 | 0.07 units on a scale | Standard Error 0.22 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 14 | 0.06 units on a scale | Standard Error 0.17 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 16 | 0.09 units on a scale | Standard Error 0.153 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 17 | 0.05 units on a scale | Standard Error 0.165 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 18 | -0.05 units on a scale | Standard Error 0.131 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 19 | -0.04 units on a scale | Standard Error 0.139 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 20 | 0.30 units on a scale | Standard Error 0.226 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 21 | 0.23 units on a scale | Standard Error 0.16 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 22 | 0.01 units on a scale | Standard Error 0.12 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 23 | -0.01 units on a scale | Standard Error 0.14 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 24 | 0.02 units on a scale | Standard Error 0.132 |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change From RW Period Baseline Over Time in Weekly Average of Pericarditis Pain in the RW Period | Change at RW Week 25 | 0.13 units on a scale | Standard Error 0.11 |
Secondary
Change in ISI Categories From RI Period Baseline to RI Period Week 12
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).
Time frame: RI Period Baseline (BL), RI Period Week (Wk) 12
Population: Run-in Analysis Set: All participants who received at least 1 dose of study drug in the RI period. Participants 18 years or older with an assessment.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RI Period Baseline to RI Period Week 12 | BL No Clinically Significant Insomnia | Wk 12 No Clinically Significant Insomnia | 23 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RI Period Baseline to RI Period Week 12 | BL No Clinically Significant Insomnia | Wk 12 Subthreshold Insomnia | 1 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RI Period Baseline to RI Period Week 12 | BL No Clinically Significant Insomnia | Wk 12 Clinical Insomnia, Moderate Severity | 1 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RI Period Baseline to RI Period Week 12 | BL No Clinically Significant Insomnia | Wk 12 Clinical Insomnia, Severe | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RI Period Baseline to RI Period Week 12 | BL No Clinically Significant Insomnia | Wk 12 Missing | 1 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RI Period Baseline to RI Period Week 12 | BL Subthreshold Insomnia | Wk 12 No Clinically Significant Insomnia | 18 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RI Period Baseline to RI Period Week 12 | BL Subthreshold Insomnia | Wk 12 Subthreshold Insomnia | 7 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RI Period Baseline to RI Period Week 12 | BL Subthreshold Insomnia | Wk 12 Clinical Insomnia, Moderate Severity | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RI Period Baseline to RI Period Week 12 | BL Subthreshold Insomnia | Wk 12 Clinical Insomnia, Severe | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RI Period Baseline to RI Period Week 12 | BL Subthreshold Insomnia | Wk 12 Missing | 2 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RI Period Baseline to RI Period Week 12 | BL Clinical Insomnia, Moderate Severity | Wk 12 No Clinically Significant Insomnia | 7 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RI Period Baseline to RI Period Week 12 | BL Clinical Insomnia, Moderate Severity | Wk 12 Subthreshold Insomnia | 10 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RI Period Baseline to RI Period Week 12 | BL Clinical Insomnia, Moderate Severity | Wk 12 Clinical Insomnia, Moderate Severity | 2 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RI Period Baseline to RI Period Week 12 | BL Clinical Insomnia, Moderate Severity | Wk 12 Clinical Insomnia, Severe | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RI Period Baseline to RI Period Week 12 | BL Clinical Insomnia, Moderate Severity | Wk 12 Missing | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RI Period Baseline to RI Period Week 12 | BL Clinical Insomnia, Severe | Wk 12 No Clinically Significant Insomnia | 2 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RI Period Baseline to RI Period Week 12 | BL Clinical Insomnia, Severe | Wk 12 Subthreshold Insomnia | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RI Period Baseline to RI Period Week 12 | BL Clinical Insomnia, Severe | Wk 12 Clinical Insomnia, Moderate Severity | 1 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RI Period Baseline to RI Period Week 12 | BL Clinical Insomnia, Severe | Wk 12 Clinical Insomnia, Severe | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RI Period Baseline to RI Period Week 12 | BL Clinical Insomnia, Severe | Wk 12 Missing | 1 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RI Period Baseline to RI Period Week 12 | BL Missing | Wk 12 No Clinically Significant Insomnia | 3 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RI Period Baseline to RI Period Week 12 | BL Missing | Wk 12 Subthreshold Insomnia | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RI Period Baseline to RI Period Week 12 | BL Missing | Wk 12 Clinical Insomnia, Moderate Severity | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RI Period Baseline to RI Period Week 12 | BL Missing | Wk 12 Clinical Insomnia, Severe | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RI Period Baseline to RI Period Week 12 | BL Missing | Wk 12 Missing | 0 Participants |
Secondary
Change in ISI Categories From RW Period Baseline to RW Period Week 24
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).
Time frame: RW Period Baseline (BL), RW Period Week (Wk) 24
Population: ITT Week 24 Analysis Set: All participants randomized at least 24 weeks before data cutoff. Participants 18 years or older
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL Subthreshold Insomnia | Wk 24 No Clinically Significant Insomnia | 2 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL No Clinically Significant Insomnia | Wk 24 Subthreshold Insomnia | 3 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL Subthreshold Insomnia | Wk 24 Clinical Insomnia, Severe | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL Subthreshold Insomnia | Wk 24 Clinical Insomnia, Moderate Severity | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL Subthreshold Insomnia | Wk 24 Subthreshold Insomnia | 1 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL Subthreshold Insomnia | Wk 24 Missing | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL No Clinically Significant Insomnia | Wk 24 No Clinically Significant Insomnia | 7 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL No Clinically Significant Insomnia | Wk 24 Clinical Insomnia, Severe | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL Clinical Insomnia, Moderate Severity | Wk 24 No Clinically Significant Insomnia | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL Clinical Insomnia, Moderate Severity | Wk 24 Missing | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL Clinical Insomnia, Moderate Severity | Wk 24 Clinical Insomnia, Severe | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL No Clinically Significant Insomnia | Wk 24 Missing | 2 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL No Clinically Significant Insomnia | Wk 24 Clinical Insomnia, Moderate Severity | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL Clinical Insomnia, Moderate Severity | Wk 24 Clinical Insomnia, Moderate Severity | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL Clinical Insomnia, Moderate Severity | Wk 24 Subthreshold Insomnia | 2 Participants |
| Randomized Withdrawal Period: Placebo | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL No Clinically Significant Insomnia | Wk 24 No Clinically Significant Insomnia | 7 Participants |
| Randomized Withdrawal Period: Placebo | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL No Clinically Significant Insomnia | Wk 24 Clinical Insomnia, Moderate Severity | 0 Participants |
| Randomized Withdrawal Period: Placebo | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL No Clinically Significant Insomnia | Wk 24 Clinical Insomnia, Severe | 0 Participants |
| Randomized Withdrawal Period: Placebo | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL No Clinically Significant Insomnia | Wk 24 Missing | 2 Participants |
| Randomized Withdrawal Period: Placebo | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL Subthreshold Insomnia | Wk 24 No Clinically Significant Insomnia | 2 Participants |
| Randomized Withdrawal Period: Placebo | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL Subthreshold Insomnia | Wk 24 Subthreshold Insomnia | 1 Participants |
| Randomized Withdrawal Period: Placebo | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL Subthreshold Insomnia | Wk 24 Clinical Insomnia, Moderate Severity | 0 Participants |
| Randomized Withdrawal Period: Placebo | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL Subthreshold Insomnia | Wk 24 Clinical Insomnia, Severe | 0 Participants |
| Randomized Withdrawal Period: Placebo | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL Subthreshold Insomnia | Wk 24 Missing | 0 Participants |
| Randomized Withdrawal Period: Placebo | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL Clinical Insomnia, Moderate Severity | Wk 24 No Clinically Significant Insomnia | 0 Participants |
| Randomized Withdrawal Period: Placebo | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL Clinical Insomnia, Moderate Severity | Wk 24 Subthreshold Insomnia | 2 Participants |
| Randomized Withdrawal Period: Placebo | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL Clinical Insomnia, Moderate Severity | Wk 24 Clinical Insomnia, Moderate Severity | 0 Participants |
| Randomized Withdrawal Period: Placebo | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL Clinical Insomnia, Moderate Severity | Wk 24 Clinical Insomnia, Severe | 0 Participants |
| Randomized Withdrawal Period: Placebo | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL Clinical Insomnia, Moderate Severity | Wk 24 Missing | 0 Participants |
| Randomized Withdrawal Period: Placebo | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL Clinical Insomnia, Severe | Wk 24 No Clinically Significant Insomnia | 0 Participants |
| Randomized Withdrawal Period: Placebo | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL No Clinically Significant Insomnia | Wk 24 Subthreshold Insomnia | 3 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL Subthreshold Insomnia | Wk 24 Subthreshold Insomnia | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL No Clinically Significant Insomnia | Wk 24 Missing | 8 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL No Clinically Significant Insomnia | Wk 24 Clinical Insomnia, Moderate Severity | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL Subthreshold Insomnia | Wk 24 Missing | 4 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL Subthreshold Insomnia | Wk 24 Clinical Insomnia, Moderate Severity | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL No Clinically Significant Insomnia | Wk 24 No Clinically Significant Insomnia | 2 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL Subthreshold Insomnia | Wk 24 No Clinically Significant Insomnia | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL No Clinically Significant Insomnia | Wk 24 Subthreshold Insomnia | 1 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL Subthreshold Insomnia | Wk 24 Clinical Insomnia, Severe | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL No Clinically Significant Insomnia | Wk 24 Clinical Insomnia, Severe | 0 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL Subthreshold Insomnia | Wk 24 Clinical Insomnia, Severe | 0 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL No Clinically Significant Insomnia | Wk 24 Missing | 1 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL No Clinically Significant Insomnia | Wk 24 No Clinically Significant Insomnia | 9 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL No Clinically Significant Insomnia | Wk 24 Clinical Insomnia, Severe | 0 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL Subthreshold Insomnia | Wk 24 Missing | 0 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL Subthreshold Insomnia | Wk 24 Subthreshold Insomnia | 2 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL Subthreshold Insomnia | Wk 24 No Clinically Significant Insomnia | 2 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL No Clinically Significant Insomnia | Wk 24 Subthreshold Insomnia | 1 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL Subthreshold Insomnia | Wk 24 Clinical Insomnia, Moderate Severity | 0 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Change in ISI Categories From RW Period Baseline to RW Period Week 24 | BL No Clinically Significant Insomnia | Wk 24 Clinical Insomnia, Moderate Severity | 0 Participants |
Secondary
Major Secondary Efficacy Endpoint: Percentage of Days With No or Minimal Pericarditis Pain at Week 16 of the RW Period
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.
Time frame: RW Period Week 16
Population: ITT Week 16 Analysis Set: All participants randomized at least 16 weeks before data cutoff.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Major Secondary Efficacy Endpoint: Percentage of Days With No or Minimal Pericarditis Pain at Week 16 of the RW Period | 98.6 percentage of days | Standard Error 7.55 |
| Randomized Withdrawal Period: Placebo | Major Secondary Efficacy Endpoint: Percentage of Days With No or Minimal Pericarditis Pain at Week 16 of the RW Period | 47.4 percentage of days | Standard Error 7.26 |
p-value: <0.000195% CI: [34.5, 68]ANCOVA
Secondary
Major Secondary Efficacy Endpoint: Percentage of Participants Who Maintained Clinical Response at Week 16 of the RW Period
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.
Time frame: RW Period Week 16
Population: ITT Week 16 Analysis Set: All participants randomized at least 16 weeks before data cutoff.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Major Secondary Efficacy Endpoint: Percentage of Participants Who Maintained Clinical Response at Week 16 of the RW Period | 81.0 percentage of participants |
| Randomized Withdrawal Period: Placebo | Major Secondary Efficacy Endpoint: Percentage of Participants Who Maintained Clinical Response at Week 16 of the RW Period | 20.0 percentage of participants |
p-value: 0.000295% CI: [2.438, 66.428]Cochran-Mantel-Haenszel
95% CI: [36.7, 85.2]
Secondary
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
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.
Time frame: RW Period Week 16
Population: ITT Week 16 Analysis Set: All participants randomized at least 16 weeks before data cutoff.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized Withdrawal Period: Rilonacept | 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 | 81.0 percentage of participants |
| Randomized Withdrawal Period: Placebo | 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 | 25.0 percentage of participants |
p-value: 0.000695% CI: [2.136, 46.826]Cochran-Mantel-Haenszel
95% CI: [30.6, 81.3]
Secondary
Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period
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).
Time frame: RW Period Baseline, RW Period Week 24, RW Period (mean 24.8 weeks)
Population: ITT Analysis Set: all participants who were randomized in the RW period. Participants with a non-missing value at given time point.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Week 24 | Large | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Week 24 | Moderate | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Baseline | Missing/Not Done | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Worst Post-baseline | Missing/Not Done | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Week 24 | Small | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Week 24 | None or Trivial/Physiologic | 12 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Worst Post-baseline | Large | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Worst Post-baseline | Moderate | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Baseline | Moderate | 1 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Baseline | None or Trivial/Physiologic | 28 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Worst Post-baseline | Small | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Worst Post-baseline | None or Trivial/Physiologic | 28 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Baseline | Large | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Worst Post-baseline | Very Large | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Week 24 | Missing/Not Done | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Week 24 | Very Large | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Baseline | Very Large | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Baseline | Small | 1 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Baseline | Moderate | 1 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Baseline | None or Trivial/Physiologic | 28 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Baseline | Small | 1 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Baseline | Large | 0 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Baseline | Very Large | 0 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Baseline | Missing/Not Done | 0 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Week 24 | None or Trivial/Physiologic | 12 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Week 24 | Small | 0 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Week 24 | Moderate | 0 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Week 24 | Large | 0 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Week 24 | Very Large | 0 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Week 24 | Missing/Not Done | 0 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Worst Post-baseline | None or Trivial/Physiologic | 28 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Worst Post-baseline | Small | 0 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Worst Post-baseline | Moderate | 0 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Worst Post-baseline | Large | 0 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Worst Post-baseline | Very Large | 0 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Worst Post-baseline | Missing/Not Done | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Baseline | Very Large | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Week 24 | Large | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Week 24 | Very Large | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Baseline | Large | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Worst Post-baseline | Missing/Not Done | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Week 24 | Missing/Not Done | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Worst Post-baseline | Very Large | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Worst Post-baseline | None or Trivial/Physiologic | 14 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Baseline | Moderate | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Worst Post-baseline | Small | 4 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Baseline | None or Trivial/Physiologic | 30 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Worst Post-baseline | Moderate | 1 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Baseline | Small | 1 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Week 24 | None or Trivial/Physiologic | 3 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Baseline | Missing/Not Done | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Week 24 | Small | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Worst Post-baseline | Large | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Week 24 | Moderate | 0 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Week 24 | None or Trivial/Physiologic | 13 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Worst Post-baseline | Large | 0 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Worst Post-baseline | Small | 7 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Week 24 | Large | 0 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Baseline | Large | 0 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Baseline | None or Trivial/Physiologic | 30 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Baseline | Small | 1 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Week 24 | Very Large | 0 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Baseline | Very Large | 0 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Worst Post-baseline | Missing/Not Done | 0 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Worst Post-baseline | Moderate | 1 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Week 24 | Missing/Not Done | 0 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Baseline | Moderate | 0 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Baseline | Missing/Not Done | 0 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Week 24 | Moderate | 0 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Worst Post-baseline | None or Trivial/Physiologic | 20 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Week 24 | Small | 0 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants in ECHO Pericardial Effusion Size Categories at RW Period Baseline, RW Week 24 and Worst Post-baseline in the RW Period | RW Worst Post-baseline | Very Large | 0 Participants |
Secondary
Number of Participants Who Were Off Background Pericarditis Medication on or Before RI Period Weeks 4, 8, 10, and 12
Time frame: RI Period Baseline, RI Period Weeks 4, 8, 10, 12
Population: Run-in Analysis Set: All participants who received at least 1 dose of study drug in the RI period. Participants 18 years or older with an assessment at given time point.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Number of Participants Who Were Off Background Pericarditis Medication on or Before RI Period Weeks 4, 8, 10, and 12 | RI Week 12 | Not Receiving Background Pericarditis Medication | 76 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants Who Were Off Background Pericarditis Medication on or Before RI Period Weeks 4, 8, 10, and 12 | RI Week 12 | Receiving Background Pericarditis Medication | 3 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants Who Were Off Background Pericarditis Medication on or Before RI Period Weeks 4, 8, 10, and 12 | RI Baseline | Not Receiving Background Pericarditis Medication | 7 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants Who Were Off Background Pericarditis Medication on or Before RI Period Weeks 4, 8, 10, and 12 | RI Baseline | Receiving Background Pericarditis Medication | 79 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants Who Were Off Background Pericarditis Medication on or Before RI Period Weeks 4, 8, 10, and 12 | RI Week 4 | Not Receiving Background Pericarditis Medication | 15 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants Who Were Off Background Pericarditis Medication on or Before RI Period Weeks 4, 8, 10, and 12 | RI Week 4 | Receiving Background Pericarditis Medication | 69 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants Who Were Off Background Pericarditis Medication on or Before RI Period Weeks 4, 8, 10, and 12 | RI Week 8 | Not Receiving Background Pericarditis Medication | 49 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants Who Were Off Background Pericarditis Medication on or Before RI Period Weeks 4, 8, 10, and 12 | RI Week 8 | Receiving Background Pericarditis Medication | 32 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants Who Were Off Background Pericarditis Medication on or Before RI Period Weeks 4, 8, 10, and 12 | RI Week 10 | Not Receiving Background Pericarditis Medication | 71 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants Who Were Off Background Pericarditis Medication on or Before RI Period Weeks 4, 8, 10, and 12 | RI Week 10 | Receiving Background Pericarditis Medication | 9 Participants |
Secondary
Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24
Time frame: LTE Week 24
Population: Long term extension (LTE) Analysis Set - MRI Substudy: participants in MRI Substudy who consented to LTE period and took at least 1 dose of study drug in the LTE period. Participants 18 years or older with an assessment at given time point.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Delayed Hyperenhancement=Yes | LTE Week 24=Missing | 1 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Effusion=No | LTE Week 24=Missing | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Delayed Hyperenhancement=Missing | LTE Week 24=Missing | 4 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Effusion=Yes | LTE Week 24=Missing | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Effusion=Yes | LTE Week 24=No | 1 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Effusion=Yes | LTE Week 24=Yes | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Myocardial Delayed Hyperenhancement=Yes | LTE Week 24=Yes | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Myocardial Delayed Hyperenhancement=Missing | LTE Week 24=No | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Myocardial Delayed Hyperenhancement=Missing | LTE Week 24=Yes | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Effusion=No | LTE Week 24=No | 3 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Myocardial Delayed Hyperenhancement=Yes | LTE Week 24=No | 1 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Effusion=Missing | LTE Week 24=Yes | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Delayed Hyperenhancement=Missing | LTE Week 24=Yes | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Delayed Hyperenhancement=Yes | LTE Week 24=Yes | 2 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Myocardial Delayed Hyperenhancement=Yes | LTE Week 24=Missing | 1 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Effusion=Missing | LTE Week 24=Missing | 4 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Myocardial Delayed Hyperenhancement=No | LTE Week 24=Missing | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Effusion=No | LTE Week 24=Yes | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Myocardial Delayed Hyperenhancement=No | LTE Week 24=Yes | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Delayed Hyperenhancement=Missing | LTE Week 24=No | 0 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Delayed Hyperenhancement=Yes | LTE Week 24=No | 1 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Myocardial Delayed Hyperenhancement=Missing | LTE Week 24=Missing | 4 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Myocardial Delayed Hyperenhancement=No | LTE Week 24=No | 2 Participants |
| Randomized Withdrawal Period: Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Effusion=Missing | LTE Week 24=No | 0 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Delayed Hyperenhancement=No | LTE Week 24=Yes | 0 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Myocardial Delayed Hyperenhancement=No | LTE Week 24=Yes | 0 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Effusion=Yes | LTE Week 24=Missing | 0 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Myocardial Delayed Hyperenhancement=No | LTE Week 24=No | 6 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Myocardial Delayed Hyperenhancement=No | LTE Week 24=Missing | 3 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Delayed Hyperenhancement=No | LTE Week 24=No | 1 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Effusion=Yes | LTE Week 24=No | 1 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Myocardial Delayed Hyperenhancement=Missing | LTE Week 24=Yes | 0 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Delayed Hyperenhancement=Yes | LTE Week 24=No | 1 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Myocardial Delayed Hyperenhancement=Missing | LTE Week 24=No | 1 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Effusion=Yes | LTE Week 24=Yes | 0 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Myocardial Delayed Hyperenhancement=Missing | LTE Week 24=Missing | 1 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Effusion=Missing | LTE Week 24=Yes | 0 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Delayed Hyperenhancement=No | LTE Week 24=Missing | 1 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Delayed Hyperenhancement=Yes | LTE Week 24=Yes | 5 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Delayed Hyperenhancement=Missing | LTE Week 24=Yes | 0 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Effusion=No | LTE Week 24=Missing | 4 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Delayed Hyperenhancement=Missing | LTE Week 24=No | 1 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Delayed Hyperenhancement=Missing | LTE Week 24=Missing | 1 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Delayed Hyperenhancement=Yes | LTE Week 24=Missing | 3 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Effusion=No | LTE Week 24=No | 6 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Myocardial Delayed Hyperenhancement=Yes | LTE Week 24=Yes | 0 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Effusion=Missing | LTE Week 24=Missing | 1 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Myocardial Delayed Hyperenhancement=Yes | LTE Week 24=No | 0 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Effusion=Missing | LTE Week 24=No | 1 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Effusion=No | LTE Week 24=Yes | 0 Participants |
| Randomized Withdrawal Period: Placebo | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Myocardial Delayed Hyperenhancement=Yes | LTE Week 24=Missing | 2 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Myocardial Delayed Hyperenhancement=Missing | LTE Week 24=No | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Delayed Hyperenhancement=Yes | LTE Week 24=Yes | 2 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Delayed Hyperenhancement=Yes | LTE Week 24=No | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Delayed Hyperenhancement=Yes | LTE Week 24=Missing | 8 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Delayed Hyperenhancement=No | LTE Week 24=Yes | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Delayed Hyperenhancement=No | LTE Week 24=No | 2 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Delayed Hyperenhancement=No | LTE Week 24=Missing | 2 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Delayed Hyperenhancement=Missing | LTE Week 24=Yes | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Delayed Hyperenhancement=Missing | LTE Week 24=No | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Delayed Hyperenhancement=Missing | LTE Week 24=Missing | 2 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Myocardial Delayed Hyperenhancement=Yes | LTE Week 24=Yes | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Myocardial Delayed Hyperenhancement=Yes | LTE Week 24=No | 2 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Myocardial Delayed Hyperenhancement=Yes | LTE Week 24=Missing | 1 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Myocardial Delayed Hyperenhancement=No | LTE Week 24=Yes | 1 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Myocardial Delayed Hyperenhancement=No | LTE Week 24=No | 1 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Myocardial Delayed Hyperenhancement=No | LTE Week 24=Missing | 9 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Myocardial Delayed Hyperenhancement=Missing | LTE Week 24=Yes | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Myocardial Delayed Hyperenhancement=Missing | LTE Week 24=Missing | 2 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Effusion=No | LTE Week 24=Yes | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Effusion=No | LTE Week 24=No | 4 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Effusion=No | LTE Week 24=Missing | 10 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Effusion=Missing | LTE Week 24=Yes | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Effusion=Missing | LTE Week 24=No | 0 Participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Effusion=Missing | LTE Week 24=Missing | 2 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Myocardial Delayed Hyperenhancement=No | LTE Week 24=No | 9 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Myocardial Delayed Hyperenhancement=No | LTE Week 24=Yes | 1 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Effusion=Yes | LTE Week 24=Missing | 0 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Myocardial Delayed Hyperenhancement=Yes | LTE Week 24=Missing | 4 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Myocardial Delayed Hyperenhancement=Yes | LTE Week 24=No | 3 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Effusion=Missing | LTE Week 24=Missing | 7 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Effusion=No | LTE Week 24=Yes | 0 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Myocardial Delayed Hyperenhancement=Yes | LTE Week 24=Yes | 0 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Delayed Hyperenhancement=Missing | LTE Week 24=Missing | 7 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Effusion=Missing | LTE Week 24=No | 1 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Effusion=No | LTE Week 24=No | 13 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Delayed Hyperenhancement=Missing | LTE Week 24=No | 1 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Delayed Hyperenhancement=Missing | LTE Week 24=Yes | 0 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Delayed Hyperenhancement=Yes | LTE Week 24=No | 2 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Effusion=No | LTE Week 24=Missing | 14 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Delayed Hyperenhancement=No | LTE Week 24=Missing | 3 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Delayed Hyperenhancement=No | LTE Week 24=No | 3 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Delayed Hyperenhancement=Yes | LTE Week 24=Yes | 9 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Effusion=Missing | LTE Week 24=Yes | 0 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Delayed Hyperenhancement=No | LTE Week 24=Yes | 0 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Delayed Hyperenhancement=Yes | LTE Week 24=Missing | 12 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Myocardial Delayed Hyperenhancement=Missing | LTE Week 24=Missing | 7 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Myocardial Delayed Hyperenhancement=Missing | LTE Week 24=No | 1 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Effusion=Yes | LTE Week 24=Yes | 0 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Myocardial Delayed Hyperenhancement=Missing | LTE Week 24=Yes | 0 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Myocardial Delayed Hyperenhancement=No | LTE Week 24=Missing | 12 Participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Number of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion at LTE Period Week 24 | LTE BL: Pericardial Effusion=Yes | LTE Week 24=No | 2 Participants |
Secondary
Percentage of Days With No or Minimal Pain in the RI Period While on Treatment
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'.
Time frame: RI Period (up to Week 12)
Population: Run-in Analysis Set: All participants who received at least 1 dose of study drug in the RI period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Percentage of Days With No or Minimal Pain in the RI Period While on Treatment | 80.66 percentage of days | Standard Deviation 21.388 |
Secondary
Percentage of Days With No or Minimal Pericarditis Pain at Week 24 of the RW Period
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.
Time frame: RW Period Week 24
Population: ITT Week 24 Analysis Set: All participants randomized at least 24 weeks before data cutoff.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Percentage of Days With No or Minimal Pericarditis Pain at Week 24 of the RW Period | 100.6 percentage of days | Standard Error 8.02 |
| Randomized Withdrawal Period: Placebo | Percentage of Days With No or Minimal Pericarditis Pain at Week 24 of the RW Period | 48.7 percentage of days | Standard Error 7.64 |
p-value: <0.000195% CI: [33.8, 70.1]ANCOVA
Secondary
Percentage of Days With No or Minimal Pericarditis Pain at Week 8 of the RW Period
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.
Time frame: RW Period Week 8
Population: ITT Week 8 Analysis Set: All participants randomized at least 8 weeks before data cutoff.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Percentage of Days With No or Minimal Pericarditis Pain at Week 8 of the RW Period | 97.9 percentage of days | Standard Error 7.64 |
| Randomized Withdrawal Period: Placebo | Percentage of Days With No or Minimal Pericarditis Pain at Week 8 of the RW Period | 57.3 percentage of days | Standard Error 7.19 |
p-value: <0.000195% CI: [25.3, 55.8]ANCOVA
Secondary
Percentage of Participants Achieving Clinical Response at RI Period Week 12
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.
Time frame: RI Period Week 12
Population: Run-in Analysis Set: All participants who received at least 1 dose of study drug in the RI period. Participants achieving treatment response in the RI period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants Achieving Clinical Response at RI Period Week 12 | Achieved Clinical Response | 84.9 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants Achieving Clinical Response at RI Period Week 12 | Did Not Achieve Clinical Response | 15.1 percentage of participants |
Secondary
Percentage of Participants Requiring Addition of Standard of Care (SOC) Pericarditis Therapy Every 4 Weeks Cumulatively in the LTE Period
Time frame: LTE Period, through LTE Follow up (up to Week 24)
Population: This analysis was not done because Standard of Care treatment was not initiated in the LTE period.
Secondary
Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period
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.
Time frame: RW Period (mean 24.8 weeks)
Population: ITT Analysis Set: all participants who were randomized in the RW period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | ORT : First Use ≤ 4 Weeks | 0 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Corticosteroid : First Use ≤ 24 Weeks | 0 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | ORT : First Use ≤ 16 Weeks | 3.3 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | ORT : First Use ≤ 8 Weeks | 0 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Bailout : First Use ≤ 4 Weeks | 0 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | ORT : First Use ≤ 12 Weeks | 0 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Bailout : First Use ≤ 8 Weeks | 0 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | ORT : First Use ≤ 24 Weeks | 3.3 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Bailout : First Use ≤ 12 Weeks | 0 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Corticosteroid : First Use ≤ 8 Weeks | 0 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Bailout : First Use ≤ 20 Weeks | 0 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | ORT : All Weeks (Including > 24 Weeks in RW Period) | 3.3 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Bailout : First Use ≤ 24 Weeks | 0 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Corticosteroid : All Weeks (Including > 24 Weeks in RW Period) | 0 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Bailout : All Weeks (Including > 24 Weeks in RW Period) | 3.3 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Corticosteroid : First Use ≤ 4 Weeks | 0 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Total (any of the above) : First Use ≤ 4 Weeks | 0 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Bailout : First Use ≤ 16 Weeks | 0 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Total (any of the above) : First Use ≤ 8 Weeks | 0 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | ORT : First Use ≤ 20 Weeks | 3.3 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Total (any of the above) : First Use ≤ 12 Weeks | 0 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Corticosteroid : First Use ≤ 12 Weeks | 0 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Total (any of the above) : First Use ≤ 16 Weeks | 3.3 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Total (any of the above) : First Use ≤ 24 Weeks | 3.3 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Total (any of the above) : First Use ≤ 20 Weeks | 3.3 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Corticosteroid : First Use ≤ 16 Weeks | 0 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Total (any of the above) : All Weeks (Including > 24 Weeks in RW Period) | 6.7 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Corticosteroid : First Use ≤ 20 Weeks | 0 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Total (any of the above) : All Weeks (Including > 24 Weeks in RW Period) | 77.4 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | ORT : First Use ≤ 16 Weeks | 6.5 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | ORT : First Use ≤ 20 Weeks | 6.5 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Bailout : First Use ≤ 16 Weeks | 67.7 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | ORT : First Use ≤ 4 Weeks | 3.2 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | ORT : First Use ≤ 12 Weeks | 6.5 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | ORT : First Use ≤ 24 Weeks | 6.5 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | ORT : All Weeks (Including > 24 Weeks in RW Period) | 6.5 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Corticosteroid : First Use ≤ 4 Weeks | 0 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Corticosteroid : First Use ≤ 8 Weeks | 0 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Corticosteroid : First Use ≤ 12 Weeks | 0 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Corticosteroid : First Use ≤ 16 Weeks | 0 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Corticosteroid : First Use ≤ 20 Weeks | 0 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Corticosteroid : First Use ≤ 24 Weeks | 0 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Corticosteroid : All Weeks (Including > 24 Weeks in RW Period) | 0 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Bailout : First Use ≤ 4 Weeks | 29.0 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Bailout : First Use ≤ 8 Weeks | 48.4 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Bailout : First Use ≤ 12 Weeks | 61.3 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Bailout : First Use ≤ 20 Weeks | 71.0 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Bailout : First Use ≤ 24 Weeks | 71.0 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Bailout : All Weeks (Including > 24 Weeks in RW Period) | 74.2 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Total (any of the above) : First Use ≤ 4 Weeks | 32.3 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Total (any of the above) : First Use ≤ 8 Weeks | 51.6 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Total (any of the above) : First Use ≤ 12 Weeks | 64.5 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Total (any of the above) : First Use ≤ 16 Weeks | 71.0 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Total (any of the above) : First Use ≤ 20 Weeks | 74.2 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | Total (any of the above) : First Use ≤ 24 Weeks | 74.2 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants Using Oral Rescue Therapy (ORT), Corticosteroid, or Bailout Rilonacept for Pericarditis Every 4 Weeks Cumulatively in the RW Period | ORT : First Use ≤ 8 Weeks | 6.5 percentage of participants |
Comparison: Participants who used ORT, corticosteroids or bailout rilonacept during the RW Periodp-value: <0.000195% CI: [0.002, 0.108]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Using ORT for Pericarditis in the First 24 Weeks of RW Period
ORT included analgesics, NSAIDs, and/or colchicine.
Time frame: RW Period (up to Week 24)
Population: ITT Analysis Set: all participants who were randomized in the RW period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants Using ORT for Pericarditis in the First 24 Weeks of RW Period | 3.3 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants Using ORT for Pericarditis in the First 24 Weeks of RW Period | 6.5 percentage of participants |
Secondary
Percentage of Participants Who Maintained Clinical Response at Week 24 of the RW Period
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.
Time frame: RW Period Week 24
Population: ITT Week 24 Analysis Set: All participants randomized at least 24 weeks before data cutoff.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants Who Maintained Clinical Response at Week 24 of the RW Period | 76.5 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants Who Maintained Clinical Response at Week 24 of the RW Period | 20.0 percentage of participants |
p-value: 0.002295% CI: [1.317, 53.188]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Maintained Clinical Response at Week 8 of the RW Period
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.
Time frame: RW Period Week 8
Population: ITT Week 8 Analysis Set: All participants randomized at least 8 weeks before data cutoff.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants Who Maintained Clinical Response at Week 8 of the RW Period | 77.8 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants Who Maintained Clinical Response at Week 8 of the RW Period | 25.8 percentage of participants |
p-value: <0.000195% CI: [3.051, 38.981]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Absent or Minimal Pericarditis Activity In the LTE Period Based on the PGIPS
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).
Time frame: LTE Baseline, LTE Month 12, LTE Month 24
Population: Long term extension (LTE) Analysis Set: participants who consented to LTE period and took at least 1 dose of study drug in the LTE period. Participants with an assessment at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants With Absent or Minimal Pericarditis Activity In the LTE Period Based on the PGIPS | LTE Baseline | 100.0 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants With Absent or Minimal Pericarditis Activity In the LTE Period Based on the PGIPS | LTE Week 24 | 86.7 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants With Absent or Minimal Pericarditis Activity In the LTE Period Based on the PGIPS | LTE Week 12 | 93.3 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants With Absent or Minimal Pericarditis Activity In the LTE Period Based on the PGIPS | LTE Baseline | 88.0 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants With Absent or Minimal Pericarditis Activity In the LTE Period Based on the PGIPS | LTE Week 24 | 78.3 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants With Absent or Minimal Pericarditis Activity In the LTE Period Based on the PGIPS | LTE Week 12 | 95.8 percentage of participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Percentage of Participants With Absent or Minimal Pericarditis Activity In the LTE Period Based on the PGIPS | LTE Week 12 | 100.0 percentage of participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Percentage of Participants With Absent or Minimal Pericarditis Activity In the LTE Period Based on the PGIPS | LTE Baseline | 91.2 percentage of participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Percentage of Participants With Absent or Minimal Pericarditis Activity In the LTE Period Based on the PGIPS | LTE Week 24 | 93.3 percentage of participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Percentage of Participants With Absent or Minimal Pericarditis Activity In the LTE Period Based on the PGIPS | LTE Baseline | 91.9 percentage of participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Percentage of Participants With Absent or Minimal Pericarditis Activity In the LTE Period Based on the PGIPS | LTE Week 24 | 86.8 percentage of participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Percentage of Participants With Absent or Minimal Pericarditis Activity In the LTE Period Based on the PGIPS | LTE Week 12 | 97.2 percentage of participants |
Secondary
Percentage of Participants With Absent or Minimal Pericarditis Activity Over Time in the LTE Period Based on the PGA-PA
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.
Time frame: LTE Baseline, LTE Week 12, LTE Week 24
Population: Long term extension (LTE) Analysis Set: participants who consented to LTE period and took at least 1 dose of study drug in the LTE period. Participants with an assessment at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants With Absent or Minimal Pericarditis Activity Over Time in the LTE Period Based on the PGA-PA | LTE Baseline | 100.0 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants With Absent or Minimal Pericarditis Activity Over Time in the LTE Period Based on the PGA-PA | LTE Week 24 | 93.3 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants With Absent or Minimal Pericarditis Activity Over Time in the LTE Period Based on the PGA-PA | LTE Week 12 | 100.0 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants With Absent or Minimal Pericarditis Activity Over Time in the LTE Period Based on the PGA-PA | LTE Baseline | 92.0 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants With Absent or Minimal Pericarditis Activity Over Time in the LTE Period Based on the PGA-PA | LTE Week 24 | 88.0 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants With Absent or Minimal Pericarditis Activity Over Time in the LTE Period Based on the PGA-PA | LTE Week 12 | 91.7 percentage of participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Percentage of Participants With Absent or Minimal Pericarditis Activity Over Time in the LTE Period Based on the PGA-PA | LTE Week 12 | 97.0 percentage of participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Percentage of Participants With Absent or Minimal Pericarditis Activity Over Time in the LTE Period Based on the PGA-PA | LTE Baseline | 94.1 percentage of participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Percentage of Participants With Absent or Minimal Pericarditis Activity Over Time in the LTE Period Based on the PGA-PA | LTE Week 24 | 96.8 percentage of participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Percentage of Participants With Absent or Minimal Pericarditis Activity Over Time in the LTE Period Based on the PGA-PA | LTE Baseline | 94.6 percentage of participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Percentage of Participants With Absent or Minimal Pericarditis Activity Over Time in the LTE Period Based on the PGA-PA | LTE Week 24 | 93.0 percentage of participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Percentage of Participants With Absent or Minimal Pericarditis Activity Over Time in the LTE Period Based on the PGA-PA | LTE Week 12 | 95.8 percentage of participants |
Secondary
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)
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.
Time frame: RW Period Baseline, RW Period Weeks 8, 16, 24, 32, 40, 48, 56
Population: ITT Analysis Set: all participants who were randomized in the RW period. Participants with a non-missing value at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | 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) | Baseline | 96.7 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | 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) | Week 40 | 66.7 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | 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) | Week 16 | 95.0 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | 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) | Week 8 | 100 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | 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) | Week 24 | 100 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | 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) | Week 48 | 50.0 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | 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) | Week 32 | 90.9 percentage of participants |
| Randomized Withdrawal Period: Placebo | 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) | Week 16 | 95.0 percentage of participants |
| Randomized Withdrawal Period: Placebo | 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) | Week 40 | 75.0 percentage of participants |
| Randomized Withdrawal Period: Placebo | 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) | Week 8 | 100 percentage of participants |
| Randomized Withdrawal Period: Placebo | 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) | Week 48 | 50.0 percentage of participants |
| Randomized Withdrawal Period: Placebo | 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) | Baseline | 96.7 percentage of participants |
| Randomized Withdrawal Period: Placebo | 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) | Week 24 | 100 percentage of participants |
| Randomized Withdrawal Period: Placebo | 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) | Week 32 | 83.3 percentage of participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | 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) | Week 32 | 50.0 percentage of participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | 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) | Week 24 | 100 percentage of participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | 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) | Week 8 | 71.4 percentage of participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | 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) | Week 40 | 100 percentage of participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | 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) | Baseline | 100 percentage of participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | 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) | Week 16 | 100 percentage of participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | 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) | Week 56 | 100 percentage of participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | 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) | Baseline | 100 percentage of participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | 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) | Week 8 | 85.2 percentage of participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | 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) | Week 16 | 95.0 percentage of participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | 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) | Week 24 | 100 percentage of participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | 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) | Week 32 | 90.9 percentage of participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | 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) | Week 40 | 100 percentage of participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | 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) | Week 48 | 50.0 percentage of participants |
Secondary
Percentage of Participants With Absent or Minimal Pericarditis Symptoms at Week 24 of the RW Period Based on the PGIPS
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.
Time frame: RW Period Week 24
Population: ITT Week 24 Analysis Set: All participants randomized at least 24 weeks before data cutoff.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants With Absent or Minimal Pericarditis Symptoms at Week 24 of the RW Period Based on the PGIPS | 88.2 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants With Absent or Minimal Pericarditis Symptoms at Week 24 of the RW Period Based on the PGIPS | 20.0 percentage of participants |
p-value: 0.000295% CI: [4.262, 218.552]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Absent or Minimal Pericarditis Symptoms at Week 8 of the RW Period Based on the PGIPS
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.
Time frame: RW Period Week 8
Population: ITT Week 8 Analysis Set: All participants randomized at least 8 weeks before data cutoff.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants With Absent or Minimal Pericarditis Symptoms at Week 8 of the RW Period Based on the PGIPS | 85.2 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants With Absent or Minimal Pericarditis Symptoms at Week 8 of the RW Period Based on the PGIPS | 32.3 percentage of participants |
p-value: <0.000195% CI: [3.439, 60.574]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Absent or Minimal Pericarditis Symptoms Over Time After RW Period Week 24 Based on the PGIPS
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.
Time frame: RW Period Weeks 32, 40, 48, 56
Population: ITT Analysis Set: all participants who were randomized in the RW period. Participants with a non-missing value at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants With Absent or Minimal Pericarditis Symptoms Over Time After RW Period Week 24 Based on the PGIPS | Week 32 | 90.9 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants With Absent or Minimal Pericarditis Symptoms Over Time After RW Period Week 24 Based on the PGIPS | Week 48 | 100 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants With Absent or Minimal Pericarditis Symptoms Over Time After RW Period Week 24 Based on the PGIPS | Week 40 | 60.0 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants With Absent or Minimal Pericarditis Symptoms Over Time After RW Period Week 24 Based on the PGIPS | Week 32 | 83.3 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants With Absent or Minimal Pericarditis Symptoms Over Time After RW Period Week 24 Based on the PGIPS | Week 48 | 100 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants With Absent or Minimal Pericarditis Symptoms Over Time After RW Period Week 24 Based on the PGIPS | Week 40 | 66.7 percentage of participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Percentage of Participants With Absent or Minimal Pericarditis Symptoms Over Time After RW Period Week 24 Based on the PGIPS | Week 40 | 100 percentage of participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Percentage of Participants With Absent or Minimal Pericarditis Symptoms Over Time After RW Period Week 24 Based on the PGIPS | Week 32 | 50.0 percentage of participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Percentage of Participants With Absent or Minimal Pericarditis Symptoms Over Time After RW Period Week 24 Based on the PGIPS | Week 40 | 83.3 percentage of participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Percentage of Participants With Absent or Minimal Pericarditis Symptoms Over Time After RW Period Week 24 Based on the PGIPS | Week 32 | 70.0 percentage of participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Percentage of Participants With Absent or Minimal Pericarditis Symptoms Over Time After RW Period Week 24 Based on the PGIPS | Week 48 | 50.0 percentage of participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Percentage of Participants With Absent or Minimal Pericarditis Symptoms Over Time After RW Period Week 24 Based on the PGIPS | Week 56 | 100 percentage of participants |
Secondary
Percentage of Participants With CRP Normalization at RI Period Week 12
CRP normalization was defined as CRP ≤ 0.5 mg/dL.
Time frame: RI Period Week 12
Population: Run-in Analysis Set: All participants who received at least 1 dose of study drug in the RI period. Participants with a baseline CRP measurement ≥ 0.5 mg/dL.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants With CRP Normalization at RI Period Week 12 | 98.6 percentage of participants |
Secondary
Percentage of Participants With No or Minimal Pericarditis Activity Over Time in the RI Period, Based on the PGA-PA
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.
Time frame: RI Period Baseline, RI Period Weeks 6 and 12
Population: Run-in Analysis Set: All participants who received at least 1 dose of study drug in the RI period. Participants with an assessment at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants With No or Minimal Pericarditis Activity Over Time in the RI Period, Based on the PGA-PA | RI Baseline | 10.6 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants With No or Minimal Pericarditis Activity Over Time in the RI Period, Based on the PGA-PA | RI Week 6 | 94.8 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants With No or Minimal Pericarditis Activity Over Time in the RI Period, Based on the PGA-PA | RI Week 12 | 98.7 percentage of participants |
Secondary
Percentage of Participants With No or Minimal Pericarditis Symptoms Over Time in the RI Period, Based on the PGIPS
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.
Time frame: RI Period Baseline, RI Period Weeks 6 and 12
Population: Run-in Analysis Set: All participants who received at least 1 dose of study drug in the RI period. Participants with an assessment at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants With No or Minimal Pericarditis Symptoms Over Time in the RI Period, Based on the PGIPS | Baseline | 18.1 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants With No or Minimal Pericarditis Symptoms Over Time in the RI Period, Based on the PGIPS | Week 6 | 89.5 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants With No or Minimal Pericarditis Symptoms Over Time in the RI Period, Based on the PGIPS | Week 12 | 92.6 percentage of participants |
Secondary
Percentage of Participants Without Pericarditis Recurrence in the First 24 Weeks of the RW Period
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.
Time frame: up to 24 weeks in the RW Period
Population: ITT Analysis Set: all participants who were randomized in the RW period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants Without Pericarditis Recurrence in the First 24 Weeks of the RW Period | 95.7 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants Without Pericarditis Recurrence in the First 24 Weeks of the RW Period | 19.9 percentage of participants |
p-value: <0.000195% CI: [56.8, 94.6]normal approximation
Secondary
Percentage of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion on Magnetic Resonance Imaging (MRI) at RW Week 24
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
Time frame: RW Period Week 24
Population: ITT Week 24 Analysis Set: All participants randomized at least 24 weeks before data cutoff. Participants in the MRI substudy with nonmissing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion on Magnetic Resonance Imaging (MRI) at RW Week 24 | Myocardial Delayed Hyperenhancement | 0 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion on Magnetic Resonance Imaging (MRI) at RW Week 24 | Pericardial Delayed Hyperenhancement | 66.7 percentage of participants |
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion on Magnetic Resonance Imaging (MRI) at RW Week 24 | Pericardial Effusion | 0 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion on Magnetic Resonance Imaging (MRI) at RW Week 24 | Myocardial Delayed Hyperenhancement | 0 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion on Magnetic Resonance Imaging (MRI) at RW Week 24 | Pericardial Delayed Hyperenhancement | 66.7 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion on Magnetic Resonance Imaging (MRI) at RW Week 24 | Pericardial Effusion | 0 percentage of participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Percentage of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion on Magnetic Resonance Imaging (MRI) at RW Week 24 | Pericardial Effusion | 0 percentage of participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Percentage of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion on Magnetic Resonance Imaging (MRI) at RW Week 24 | Pericardial Delayed Hyperenhancement | 28.6 percentage of participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Percentage of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion on Magnetic Resonance Imaging (MRI) at RW Week 24 | Myocardial Delayed Hyperenhancement | 0 percentage of participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Percentage of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion on Magnetic Resonance Imaging (MRI) at RW Week 24 | Pericardial Delayed Hyperenhancement | 57.1 percentage of participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Percentage of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion on Magnetic Resonance Imaging (MRI) at RW Week 24 | Pericardial Effusion | 0 percentage of participants |
| Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | Percentage of Participants With Pericardial Delayed Hyperenhancement, Myocardial Delayed Hyperenhancement or Pericardial Effusion on Magnetic Resonance Imaging (MRI) at RW Week 24 | Myocardial Delayed Hyperenhancement | 0 percentage of participants |
Secondary
Percentage of Participants With Resolution of Pericarditis-Related ECHO and ECG Abnormalities at Week 12 of the RI Period
Time frame: RI Period Baseline, RI Period Week 12
Population: Run-in Analysis Set: All participants who received at least 1 dose of study drug in the RI period. Participants with ECHO and ECG abnormalities at RI Baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Percentage of Participants With Resolution of Pericarditis-Related ECHO and ECG Abnormalities at Week 12 of the RI Period | 63.6 percentage of participants |
| Randomized Withdrawal Period: Placebo | Percentage of Participants With Resolution of Pericarditis-Related ECHO and ECG Abnormalities at Week 12 of the RI Period | 100 percentage of participants |
| Randomized Withdrawal Period: Placebo, Before Bailout Rilonacept | Percentage of Participants With Resolution of Pericarditis-Related ECHO and ECG Abnormalities at Week 12 of the RI Period | 100 percentage of participants |
Secondary
Time From First Dose to CRP Normalization in the RI Period
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.
Time frame: RI Period (up to 12 weeks)
Population: Run-in Analysis Set: All participants who received at least 1 dose of study drug in the RI period. Participants with a baseline CRP measurement \>= 0.5 mg/dL.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Time From First Dose to CRP Normalization in the RI Period | 7.0 days |
Secondary
Time From First Dose to Pain Response in the RI Period
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.
Time frame: RI Period (up to 12 weeks)
Population: Run-in Analysis Set: All participants who received at least 1 dose of study drug in the RI period. Participants with a baseline NRS measurement \>= 3.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Time From First Dose to Pain Response in the RI Period | 5.0 days |
Secondary
Time From First Dose to Rilonacept Monotherapy in RI Period
Time to rilonacept monotherapy was defined as the number of weeks from first dose to the first day of achieving monotherapy.
Time frame: RI Period (up to 12 weeks)
Population: Run-in Analysis Set: All participants who received at least 1 dose of study drug in the RI period. Participants with background therapies at RI Baseline.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Time From First Dose to Rilonacept Monotherapy in RI Period | 7.3 weeks |
Secondary
Time From First Dose to Treatment Response in RI Period
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.
Time frame: RI Period (up to 12 weeks)
Population: Run-in Analysis Set: All participants who received at least 1 dose of study drug in the RI period. Participants with baseline measurements of CRP \>0.5 mg/dL and NRS \> 2.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Time From First Dose to Treatment Response in RI Period | 5.0 days |
Secondary
Time to CRP Level ≥ 1 mg/dL in the RW Period
Kaplan-Meier estimate.
Time frame: RW Period (mean 24.8 weeks)
Population: ITT Analysis Set: all participants who were randomized in the RW period.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Time to CRP Level ≥ 1 mg/dL in the RW Period | NA weeks |
| Randomized Withdrawal Period: Placebo | Time to CRP Level ≥ 1 mg/dL in the RW Period | 6.9 weeks |
p-value: <0.000195% CI: [0.02, 0.22]Log Rank
Secondary
Time to New or Worsening Pericardial Effusion on Echocardiography (ECHO) in the RW Period
Pericardial effusion based on ECHO was evaluated by the central laboratory during the RW period. Kaplan-Meier estimate.
Time frame: RW Period (mean 24.8 weeks)
Population: ITT Analysis Set: all participants who were randomized in the RW period.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Time to New or Worsening Pericardial Effusion on Echocardiography (ECHO) in the RW Period | NA weeks |
| Randomized Withdrawal Period: Placebo | Time to New or Worsening Pericardial Effusion on Echocardiography (ECHO) in the RW Period | NA weeks |
p-value: 0.0059Log Rank
Secondary
Time to Pericardial Rub in the RW Period
Kaplan-Meier estimate. A pericardial rub (also called a pericardial friction rub) is an audible medical sign used in the diagnosis of pericarditis.
Time frame: RW Period (mean 24.8 weeks)
Population: ITT Analysis Set: all participants who were randomized in the RW period.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Time to Pericardial Rub in the RW Period | NA weeks |
| Randomized Withdrawal Period: Placebo | Time to Pericardial Rub in the RW Period | NA weeks |
p-value: 0.744795% CI: [0.12, 4.46]Log Rank
Secondary
Time to Pericarditis Pain ≥ 4 on the NRS in the RW Period
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 frame: RW Period (mean 24.8 weeks)
Population: ITT Analysis Set: all participants who were randomized in the RW period.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Time to Pericarditis Pain ≥ 4 on the NRS in the RW Period | NA weeks |
| Randomized Withdrawal Period: Placebo | Time to Pericarditis Pain ≥ 4 on the NRS in the RW Period | 4.1 weeks |
p-value: <0.000195% CI: [0.05, 0.32]Log Rank
Secondary
Time to Widespread ST-segment Elevation or PR-segment Depression on Electrocardiogram (ECG) in the RW Period
Kaplan-Meier estimate. ST-segment elevation and PR-segment depression are ECG changes in the evolution of acute pericarditis.
Time frame: RW Period (mean 24.8 weeks)
Population: ITT Analysis Set: all participants who were randomized in the RW period.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Randomized Withdrawal Period: Rilonacept | Time to Widespread ST-segment Elevation or PR-segment Depression on Electrocardiogram (ECG) in the RW Period | NA weeks |
| Randomized Withdrawal Period: Placebo | Time to Widespread ST-segment Elevation or PR-segment Depression on Electrocardiogram (ECG) in the RW Period | NA weeks |
p-value: 0.206695% CI: [0.07, 1.87]Log Rank