Trial · NCT03737110
Study to Assess the Efficacy and Safety of Rilonacept Treatment in Participants With Recurrent Pericarditis
NCT03737110, Phase 3, Completed, Kiniksa Pharmaceuticals (UK), Ltd.; results first posted 2021-07-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Assess the Efficacy and Safety of Rilonacept Treatment in Participants With Recurrent Pericarditis. Trials, record NCT03737110. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03737110
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Efficacy and Safety of Rilonacept Treatment in Participants With Recurrent Pericarditis
- NCT number
- NCT03737110
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 86 participants, actual
- Lead sponsor
- Kiniksa Pharmaceuticals (UK), Ltd.
- Conditions
- Recurrent Pericarditis
- Interventions
- Rilonacept, Placebo
- First posted
- 2018-11-09
- Last updated
- 2023-09-06
- Other registries' IDs
- eudract:2018-002719-87
- Results first posted
- 2021-07-13
Source ClinicalTrials.gov
Registered outcomes64
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 registered outcomesOutcomes64
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Pericarditis Recurrence in the RW Period | RW Period (mean 24.8 weeks) | Intent-to-Treat (ITT) Analysis Set: all participants who were randomized in the RW period. | weeks | MEDIAN |
| SECONDARY | Major Secondary Efficacy Endpoint: Percentage of Participants Who Maintained Clinical Response at Week 16 of the RW Period | RW Period Week 16 | ITT Week 16 Analysis Set: All participants randomized at least 16 weeks before data cutoff. | percentage of participants | NUMBER |
| SECONDARY | Major Secondary Efficacy Endpoint: Percentage of Days With No or Minimal Pericarditis Pain at Week 16 of the RW Period | RW Period Week 16 | ITT Week 16 Analysis Set: All participants randomized at least 16 weeks before data cutoff. | percentage of days | LEAST_SQUARES_MEAN |
| 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 | RW Period Week 16 | ITT Week 16 Analysis Set: All participants randomized at least 16 weeks before data cutoff. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Maintained Clinical Response at Week 24 of the RW Period | RW Period Week 24 | ITT Week 24 Analysis Set: All participants randomized at least 24 weeks before data cutoff. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Maintained Clinical Response at Week 8 of the RW Period | RW Period Week 8 | ITT Week 8 Analysis Set: All participants randomized at least 8 weeks before data cutoff. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Days With No or Minimal Pericarditis Pain at Week 24 of the RW Period | RW Period Week 24 | ITT Week 24 Analysis Set: All participants randomized at least 24 weeks before data cutoff. | percentage of days | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Days With No or Minimal Pericarditis Pain at Week 8 of the RW Period | RW Period Week 8 | ITT Week 8 Analysis Set: All participants randomized at least 8 weeks before data cutoff. | percentage of days | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Absent or Minimal Pericarditis Symptoms at Week 24 of the RW Period Based on the PGIPS | RW Period Week 24 | ITT Week 24 Analysis Set: All participants randomized at least 24 weeks before data cutoff. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Absent or Minimal Pericarditis Symptoms at Week 8 of the RW Period Based on the PGIPS | RW Period Week 8 | ITT Week 8 Analysis Set: All participants randomized at least 8 weeks before data cutoff. | percentage of participants | NUMBER |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 outcomesResults by group1,139
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Pericarditis Recurrence in the RW Period | Randomized Withdrawal Period: Rilonacept | NA | 95% Confidence Interval NA to NA | weeks | |
| Time to Pericarditis Recurrence in the RW Period | Randomized Withdrawal Period: Placebo | 8.6 | 95% Confidence Interval 4.0 to 11.7 | weeks | |
| Major Secondary Efficacy Endpoint: Percentage of Participants Who Maintained Clinical Response at Week 16 of the RW Period | Randomized Withdrawal Period: Rilonacept | 81.0 | 95% Confidence Interval 58.1 to 94.6 | percentage of participants | |
| Major Secondary Efficacy Endpoint: Percentage of Participants Who Maintained Clinical Response at Week 16 of the RW Period | Randomized Withdrawal Period: Placebo | 20.0 | 95% Confidence Interval 5.7 to 43.7 | percentage of participants | |
| Major Secondary Efficacy Endpoint: Percentage of Days With No or Minimal Pericarditis Pain at Week 16 of the RW Period | Randomized Withdrawal Period: Rilonacept | 98.6 | Standard Error 7.55 | percentage of days | |
| Major Secondary Efficacy Endpoint: Percentage of Days With No or Minimal Pericarditis Pain at Week 16 of the RW Period | Randomized Withdrawal Period: Placebo | 47.4 | Standard Error 7.26 | percentage of days | |
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 | Randomized Withdrawal Period: Rilonacept | 81.0 | 95% Confidence Interval 58.1 to 94.6 | percentage of participants | |
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 | Randomized Withdrawal Period: Placebo | 25.0 | 95% Confidence Interval 8.7 to 49.1 | percentage of participants | |
| Percentage of Participants Who Maintained Clinical Response at Week 24 of the RW Period | Randomized Withdrawal Period: Rilonacept | 76.5 | 95% Confidence Interval 50.1 to 93.2 | percentage of participants | |
| Percentage of Participants Who Maintained Clinical Response at Week 24 of the RW Period | Randomized Withdrawal Period: Placebo | 20.0 | 95% Confidence Interval 4.3 to 48.1 | percentage of participants |
1 to 10 of 1,139Source ClinicalTrials.gov
See all 1,139 results by groupParticipant flow66
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Run-in (RI) Period | STARTED | Run-in Period | 86 | |
| Run-in (RI) Period | STARTED | Randomized Withdrawal Period: Rilonacept | 0 | |
| Run-in (RI) Period | STARTED | Randomized Withdrawal Period: Placebo | 0 | |
| Run-in (RI) Period | STARTED | Long Term Extension: Non-Randomized | 0 | |
| Run-in (RI) Period | STARTED | Long Term Extension: Randomized, Recurrence (RW) | 0 | |
| Run-in (RI) Period | STARTED | Long Term Extension: Randomized, No Recurrence (RW) | 0 | |
| Run-in (RI) Period | Continue to RW Period | Run-in Period | 61 | |
| Run-in (RI) Period | Continue to RW Period | Randomized Withdrawal Period: Rilonacept | 0 | |
| Run-in (RI) Period | Continue to RW Period | Randomized Withdrawal Period: Placebo | 0 | |
| Run-in (RI) Period | Continue to RW Period | Long Term Extension: Non-Randomized | 0 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 participant flowAdverse events270
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Run-in Period | 5 | 86 | |
| other | Diarrhoea | Gastrointestinal disorders | Randomized Withdrawal Period: Rilonacept Only, Before Bailout Rilonacept | 0 | 30 | |
| other | Diarrhoea | Gastrointestinal disorders | Randomized Withdrawal Period: Rilonacept, Including Bailout Rilonacept | 0 | 30 | |
| other | Diarrhoea | Gastrointestinal disorders | Randomized Withdrawal Period: Placebo Only, Before Bailout Rilonacept | 0 | 31 | |
| other | Diarrhoea | Gastrointestinal disorders | Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | 0 | 31 | |
| other | Diarrhoea | Gastrointestinal disorders | Long-Term Extension Period: Overall | 4 | 74 | |
| other | Fatigue | General disorders | Run-in Period | 2 | 86 | |
| other | Fatigue | General disorders | Randomized Withdrawal Period: Rilonacept Only, Before Bailout Rilonacept | 2 | 30 | |
| other | Fatigue | General disorders | Randomized Withdrawal Period: Rilonacept, Including Bailout Rilonacept | 2 | 30 | |
| other | Fatigue | General disorders | Randomized Withdrawal Period: Placebo Only, Before Bailout Rilonacept | 0 | 31 |
1 to 10 of 270Source ClinicalTrials.gov
See all 270 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Run-in Period | 0 | 86 |
| Total, all-cause mortality | Randomized Withdrawal Period: Rilonacept Only, Before Bailout Rilonacept | 0 | 30 |
| Total, all-cause mortality | Randomized Withdrawal Period: Rilonacept, Including Bailout Rilonacept | 0 | 30 |
| Total, all-cause mortality | Randomized Withdrawal Period: Placebo Only, Before Bailout Rilonacept | 0 | 31 |
| Total, all-cause mortality | Randomized Withdrawal Period: Placebo, Including Bailout Rilonacept | 0 | 31 |
| Total, all-cause mortality | Long-Term Extension Period: Overall | 0 | 74 |
| Total, other adverse events | Run-in Period | 55 | 86 |
| Total, other adverse events | Randomized Withdrawal Period: Rilonacept Only, Before Bailout Rilonacept | 18 | 30 |
| Total, other adverse events | Randomized Withdrawal Period: Rilonacept, Including Bailout Rilonacept | 18 | 30 |
| Total, other adverse events | Randomized Withdrawal Period: Placebo Only, Before Bailout Rilonacept | 7 | 31 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers8
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Treatment Risk Task | Secondary outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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