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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo (for Rilonacept) and Indomethacin | Active Comparator | 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). |
|
| Rilonacept and Indomethacin | Active Comparator | 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). |
|
| Rilonacept and Placebo (for Indomethacin) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rilonacept | Drug | Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 (Baseline). |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Evans, PharmD | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23375025 | Derived | Terkeltaub RA, Schumacher HR, Carter JD, Baraf HS, Evans RR, Wang J, King-Davis S, Weinstein SP. Rilonacept in the treatment of acute gouty arthritis: a randomized, controlled clinical trial using indomethacin as the active comparator. Arthritis Res Ther. 2013 Feb 1;15(1):R25. doi: 10.1186/ar4159. |
| Label | URL |
|---|---|
| Rilonacept | View source |
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Out of 747 participants, 225 were randomized and treated in the study. Participants were randomized in 1:1:1 ratio to receive one of the three treatment groups (Placebo [for Rilonacept] + Indomethacin or Rilonacept 320 mg + Indomethacin or Rilonacept 320 mg + Placebo [for Indomethacin]) on Day 1 of the study.
The study was conducted at 80 study sites in North America between 16 March 2009 and 26 February 2010. A total of 747 participants were screened in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo (for Rilonacept) and Indomethacin | 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). |
| FG001 | Rilonacept and Indomethacin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Indomethacin | Drug | Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days). |
|
| Placebo (for Indomethacin) | Other | Placebo (for Indomethacin) orally TID for 12 days. |
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| Placebo (for Rilonacept) | Other | Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 (Baseline). |
|
| 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 |
| Huntsville |
| Alabama |
| United States |
| Mesa | Arizona | United States |
| Phoenix | Arizona | United States |
| Sierra Vista | Arizona | United States |
| Burbank | California | United States |
| Whittier | California | United States |
| Clearwater | Florida | United States |
| DeBary | Florida | United States |
| DeLand | Florida | United States |
| Jupiter | Florida | United States |
| Orange Park | Florida | United States |
| Orlando | Florida | United States |
| Oviedo | Florida | United States |
| Boise | Idaho | United States |
| Elizabethtown | Kentucky | United States |
| Baltimore | Maryland | United States |
| Wheaton | Maryland | United States |
| Detroit | Michigan | 48221 | United States |
| Stevenville | Michigan | United States |
| Billings | Montana | United States |
| Albuquerque | New Mexico | United States |
| Albany | New York | United States |
| Burlington | North Carolina | United States |
| Cary | North Carolina | United States |
| Raleigh | North Carolina | 27612 | United States |
| Raleigh | North Carolina | United States |
| Wilmington | North Carolina | United States |
| Willoughby Hills | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Lake Oswego | Oregon | United States |
| Portland | Oregon | United States |
| Johnstown | Pennsylvania | United States |
| Limerick | Pennsylvania | United States |
| Norristown | Pennsylvania | United States |
| Greenville | South Carolina | United States |
| Bristol | Tennessee | United States |
| Dallas | Texas | United States |
| Forth Worth | Texas | United States |
| Houston | Texas | United States |
| Irving | Texas | United States |
| Mesquite | Texas | United States |
| North Richland Hills | Texas | United States |
| San Antonio | Texas | United States |
| Related Info | View source |
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). |
| FG002 | Rilonacept and Placebo (for Indomethacin) | 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. |
| Safety Population |
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| COMPLETED |
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| NOT COMPLETED |
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Baseline population included full analysis set (FAS) comprising of all randomized participants who received any study drug and had at least 1 post-baseline assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo (for Rilonacept) and Indomethacin | Two subcutaneous injections of Placebo (for Rilonacept) 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). |
| BG001 | Rilonacept and Indomethacin | 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). |
| BG002 | Rilonacept and Placebo (for Indomethacin) | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Full analysis set (FAS) that included of all randomized participants who received any study drug and had at least 1 post-baseline assessment. | Posted | Mean | Standard Deviation | units on a scale | 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 |
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| Secondary | 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. | Full analysis set (FAS) that included all randomized participants who received any study drug and had at least 1 post-baseline assessment. Here, number of participants analyzed=participants with available data for this endpoint. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 1) to 72 hours |
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| Secondary | 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. | Full analysis set (FAS) that included all randomized participants who received any study drug and had at least 1 post-baseline assessment. Here, number of participants analyzed=participants with available data for this endpoint. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 1) to 48 hours |
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| Secondary | 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. | Full analysis set (FAS) that included all randomized participants who received any study drug and had at least 1 post-baseline assessment. Here, number of participants analyzed=participants with available data for this endpoint. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 1) to 24 hours |
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Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 31) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of dosing [Day 1] of study drug up to 35 days after the dose of study medication). Analysis was performed on safety population that included all participants who received any study drug and were analyzed according to the treatment actually received (as treated).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo (for Rilonacept) and Indomethacin | Two subcutaneous injections of Placebo (for Rilonacept) 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). One participant randomized to treatment for Rilonacept and Indomethacin, received treatment for Placebo [for Rilonacept] and Indomethacin and analyzed in this arm. | 0 | 77 | 8 | 77 | ||
| EG001 | Rilonacept and Indomethacin | 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). One participant randomized to treatment for Rilonacept and Indomethacin, received treatment for Placebo [for Rilonacept] and Indomethacin and analyzed in arm (Placebo [for Rilonacept] and Indomethacin). | 3 | 73 | 7 | 73 | ||
| EG002 | Rilonacept and Placebo (for Indomethacin) | 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. | 0 | 75 | 7 | 75 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertensive cardiomyopathy | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pyoderma gangrenosum | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
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PI/Institution will provide a copy of any publication to Sponsor prior to submission for review. Sponsor may request to remove confidential information from submission, provided that removal does not preclude the complete and accurate presentation and interpretation of the study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals, Inc. | clinicaltrials@regeneron.com |
| ID | Term |
|---|---|
| D008661 | Metabolism, Inborn Errors |
| D008659 | Metabolic Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| D012216 | Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D006073 | Gout |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009750 | Nutritional and Metabolic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000070657 | Crystal Arthropathies |
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| ID | Term |
|---|---|
| C531377 | rilonacept |
| D007213 | Indomethacin |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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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.
|
|
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.
|
|
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.
|
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