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The purpose of this study was to determine the safety and tolerability of rilonacept for participants with gout who were initiating allopurinol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Experimental | Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 51. |
|
| Rilonacept 80 mg | Experimental | Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rilonacept | Drug | Rilonacept 160 mg loading dose followed by Rilonacept 80 mg/2 mL injections qw for 52 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. | Day 1 to Day 392 (Week 56) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least One Gout Flare From Day 1 to Day 168 (Week 24) | Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain; and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least one gout flare at Week 24 was to be reported for this outcome measure. |
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Inclusion Criteria:
Key Inclusion criteria:
Exclusion Criteria:
Key Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
Out of 485 participants, 220 were randomized and treated in the study. Participants were randomized in 4:3 ratio to receive either Rilonacept 80 mg or Placebo.
The study was conducted at 60 study sites in the United States (US) from 12 November 2011 to 02 November 2012. A total of 485 participants were screened in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 51. |
| FG001 | Rilonacept 80 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Placebo loading dose followed by placebo injections (2 mL) qw for 52 weeks. |
|
| Allopurinol | Drug | Allopurinol 50 or 100 mg, orally daily for 52 weeks as background treatment. |
|
| Day 1 to Day 168 (Week 24) |
| Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 168 (Week 24) | Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least two gout flares at Week 24 was to be reported for this outcome measure. | Day 1 to Day 168 (Week 24) |
| Percentage of Participants With at Least One Gout Flare From Day 1 to Day 364 (Week 52) | Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain; and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least one gout flare at Week 52 was to be reported for this outcome measure. | Day 1 to Day 364 (Week 52) |
| Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 364 (Week 52) | Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least two gout flares at Week 52 was to be reported for this outcome measure. | Day 1 to Day 364 (Week 52) |
| Percentage of Participants With Rescue Medication From Day 1 to Day 364 (Week 52) | Participants who required rescue medication after having 2 or more gout flares during the treatment period were evaluated. | Day 1 to Day 364 (Week 52) |
| Mesa |
| Arizona |
| United States |
| Phoenix | Arizona | United States |
| Scottsdale | Arizona | United States |
| Sierra Vista | Arizona | United States |
| Tucson | Arizona | United States |
| Searcy | Arkansas | United States |
| Concord | California | United States |
| La Jolla | California | United States |
| Long Beach | California | United States |
| Whittier | California | United States |
| Denver | Colorado | United States |
| Trumbull | Connecticut | United States |
| Washington D.C. | District of Columbia | United States |
| Clearwater | Florida | United States |
| DeLand | Florida | United States |
| Delray Beach | Florida | United States |
| New Port Richey | Florida | United States |
| Ocala | Florida | United States |
| Orlando | Florida | United States |
| St. Petersburg | Florida | United States |
| Tampa | Florida | United States |
| Venice | Florida | United States |
| Atlanta | Georgia | United States |
| Boise | Idaho | United States |
| Coeur d'Alene | Idaho | United States |
| Meridian | Idaho | United States |
| Avon | Indiana | United States |
| Brownsburg | Indiana | United States |
| Evansville | Indiana | United States |
| Bowling Green | Kentucky | United States |
| Elizabethtown | Kentucky | United States |
| Owensboro | Kentucky | United States |
| New Orleans | Louisiana | United States |
| Cumberland | Maryland | United States |
| Hagerstown | Maryland | United States |
| Wheaton | Maryland | United States |
| Fall River | Massachusetts | United States |
| Edina | Minnesota | United States |
| St Louis | Missouri | United States |
| Kalispell | Montana | United States |
| Omaha | Nebraska | United States |
| Brooklyn | New York | United States |
| Cary | North Carolina | United States |
| Charlotte | North Carolina | United States |
| Greensboro | North Carolina | United States |
| Greenville | North Carolina | United States |
| Raleigh | North Carolina | United States |
| Salisbury | North Carolina | United States |
| Statesville | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Akron | Ohio | United States |
| Carlisle | Ohio | United States |
| Portland | Oregon | United States |
| Huntingdon Valley | Pennsylvania | United States |
| Johnstown | Pennsylvania | United States |
| Pittsburgh | Pennsylvania | United States |
| Reading | Pennsylvania | United States |
| Anderson | South Carolina | United States |
| Charleston | South Carolina | United States |
| Columbia | South Carolina | United States |
| Greenville | South Carolina | United States |
| Rock Hill | South Carolina | United States |
| Simpsonville | South Carolina | United States |
| Dallas | Texas | United States |
| Fort Worth | Texas | United States |
| Houston | Texas | United States |
| Lake Jackson | Texas | United States |
| North Richland Hills | Texas | United States |
| San Antonio | Texas | United States |
| Sugar Land | Texas | United States |
| Salt Lake City | Utah | United States |
| Arlington | Virginia | United States |
| Spokane | Washington | United States |
Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51.
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline population included full analysis set (FAS) comprising of all randomized participants who received any study medication and was based on treatment allocated by Interactive web response system (IWRS) at randomization (as randomized).
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51. |
| BG001 | Rilonacept 80 mg | Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51. |
| BG002 | 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. | Safety analysis set (SAF) that included all randomized participants who received any study medication and was based on the treatment received (as treated). | Posted | Number | percentage of participants | Day 1 to Day 392 (Week 56) |
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| Secondary | Percentage of Participants With at Least One Gout Flare From Day 1 to Day 168 (Week 24) | Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain; and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least one gout flare at Week 24 was to be reported for this outcome measure. | As per sponsor's discretion, the study was discontinued due to which data for this outcome measure was not collected and hence, not analyzed and reported. | Posted | Day 1 to Day 168 (Week 24) |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 168 (Week 24) | Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least two gout flares at Week 24 was to be reported for this outcome measure. | As per sponsor's discretion, the study was discontinued due to which data for this outcome measure was not collected and hence, not analyzed and reported. | Posted | Day 1 to Day 168 (Week 24) |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least One Gout Flare From Day 1 to Day 364 (Week 52) | Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain; and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least one gout flare at Week 52 was to be reported for this outcome measure. | As per sponsor's discretion, the study was discontinued due to which data for this outcome measure was not collected and hence, not analyzed and reported. | Posted | Day 1 to Day 364 (Week 52) |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 364 (Week 52) | Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least two gout flares at Week 52 was to be reported for this outcome measure. | As per sponsor's discretion, the study was discontinued due to which data for this outcome measure was not collected and hence, not analyzed and reported. | Posted | Day 1 to Day 364 (Week 52) |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Rescue Medication From Day 1 to Day 364 (Week 52) | Participants who required rescue medication after having 2 or more gout flares during the treatment period were evaluated. | Safety analysis set (SAF) that included all randomized participants who received any study medication and was based on the treatment received (as treated). | Posted | Number | percentage of participants | Day 1 to Day 364 (Week 52) |
|
|
Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) 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 first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).
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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 | Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51. | 5 | 94 | 31 | 94 | ||
| EG001 | Rilonacept 80 mg | Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51. | 5 | 126 | 43 | 126 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | meddra (12.0) | Systematic Assessment |
| |
| Drug interaction | General disorders | meddra (12.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | meddra (12.0) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | meddra (12.0) | Systematic Assessment |
| |
| Limb traumatic amputation | Injury, poisoning and procedural complications | meddra (12.0) | Systematic Assessment |
| |
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra (12.0) | Systematic Assessment |
| |
| Schizoaffective disorder | Psychiatric disorders | meddra (12.0) | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | meddra (12.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | meddra (12.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | meddra (12.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | meddra (12.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | meddra (12.0) | Systematic Assessment |
| |
| Injection site erythema | General disorders | meddra (12.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | meddra (12.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | meddra (12.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | meddra (12.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | meddra (12.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | meddra (12.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | meddra (12.0) | Systematic Assessment |
|
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 |
|---|---|
| D006073 | Gout |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| D012216 | Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C531377 | rilonacept |
| D000493 | Allopurinol |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| With serious TEAEs |
|
| With TEAEs resulting in study drug discontinuation |
|
| With TEAEs resulting in death |
|
| Participants |
|
| Participants |
|
| Participants |
|
| Participants |
|
|