Study Utilizing Rilonacept in Gout Exacerbations

Study Overview
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Brief Summary
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This purpose of this clinical research was to determine the efficacy and safety of an experimental drug called Rilonacept in participants with an acute gout attack. Participants participated in this study for 30 days. Rilonacept alone was being compared with Indomethacin alone and the combination of Rilonacept plus Indomethacin in treating acute gout flares.

Official Title
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A Multi-Center, Randomized, Double-Blind, Active-Controlled Study of the Safety and Efficacy of Rilonacept Administered Subcutaneously for the Treatment of an Acute Gout Flare

Conditions
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Acute Gout Flare

Intervention / Treatment
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* Drug: Rilonacept
* Drug: Indomethacin
* Other: Placebo (for Indomethacin)
* Other: Placebo (for Rilonacept)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 18 - 70 years of age Previously met the preliminary criteria of ARA for the classification of the acute arthritis of primary gout Presenting with an acute attack (flare) of gout within 48 hours of pain onset and pain of at least moderate severity Must have at least 1 on the 0-3 scale for the swelling and the tenderness assessments of the gouty index joint Current presentation of acute gout flare in 3 joints or less Exclusion Criteria: Treatment with any non-steroidal anti-inflammatory drug (NSAIDs) or opiates within 48 hours prior to baseline assessments. Treatment with long-acting NSAIDs within 1 month prior to baseline visit. Treatment with naproxen, meloxicam, nabumetone, celecoxib and indomethacin SR within 5 days prior to baseline visit. Treatment with oral analgesics within 6 hours before baseline assessments. Treatment with topical analgesics within 12 hours before baseline assessments History of NSAID intolerance Participants with history of chronic, gouty arthritis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Placebo (for Rilonacept) and Indomethacin<br>Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally thrice a day (TID) for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days). | Drug: Indomethacin<br>* Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).<br>Other: Placebo (for Rilonacept)<br>* Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 (Baseline).<br>|
| Active Comparator: Rilonacept and Indomethacin<br>Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days). | Drug: Rilonacept<br>* Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 (Baseline).<br>Drug: Indomethacin<br>* Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).<br>|
| Active Comparator: Rilonacept and Placebo (for Indomethacin)<br>Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days. | Drug: Rilonacept<br>* Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 (Baseline).<br>Other: Placebo (for Indomethacin)<br>* Placebo (for Indomethacin) orally TID for 12 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint to Averaged PAP-LS at 24, 48 and 72 Hours | Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain. Change in PAP-LS in the index joint from baseline (Day 1) to the averaged PAP-LS values at 24, 48 and 72 hours was reported in this outcome measure (averaged PAP value= [PAP at 24 hours + PAP at 48 hours + PAP at 72 hours]/3). | Pre-dose on Day 1 (Baseline); post-dose at 4, 8, 12, 24, 48, 72 hours and then daily up to Day 13 or until gout flare ends | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 72 Hours | Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain. | Baseline (Day 1) to 72 hours | 
| Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 48 Hours | Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain. | Baseline (Day 1) to 48 hours | 
| Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 24 Hours | Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain. | Baseline (Day 1) to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolism, Inborn Errors, Allopurinol, Metabolic Diseases, Genetic Diseases, Inborn, Musculoskeletal Diseases, Joint Diseases, Arthritis, Rheumatic Diseases, Metabolic disorder, Purine-Pyrimidine Metabolism, Inborn Errors, Gout, Flare