Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This was a clinical research study to determine the safety and effectiveness of an experimental drug called rilonacept in participants with gout who were beginning another additional treatment. Participants participated in this study for approximately 24 weeks. Rilonacept was being studied for use in preventing gout attacks in participants who had gout.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 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 16. |
|
| Rilonacept 160 mg | Experimental | Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rilonacept | Biological | Rilonacept 320 mg loading dose on Day 1 followed by Rilonacept 160 mg/2 mL injections qw for 17 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Gout Flares Per Participant Assessed From Day 1 to Day 84 (Week 12) | A gout flare was defined as participant reported 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. Number of gout flares per participant was reported for this outcome measure. For drop-outs, only flares occurred before Day 84 were counted, regardless whether the flares occurred during the treatment period or not. | Day 1 (Baseline) to Day 84 (Week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least One Gout Flare From Day 1 to Day 84 (Week 12) | 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 was reported for this outcome measure. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shirletta King-Davis | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego | California | 92108 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22223180 | Derived | Schumacher HR Jr, Sundy JS, Terkeltaub R, Knapp HR, Mellis SJ, Stahl N, Yancopoulos GD, Soo Y, King-Davis S, Weinstein SP, Radin AR; 0619 Study Group. Rilonacept (interleukin-1 trap) in the prevention of acute gout flares during initiation of urate-lowering therapy: results of a phase II randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2012 Mar;64(3):876-84. doi: 10.1002/art.33412. | |
| 21372003 |
Not provided
Not provided
Out of 154 participants, 83 were randomized and treated in the study. Participants were randomized in 1:1 ratio to receive either Placebo or Rilonacept 160 mg.
The study was conducted at 27 study sites in United States (US) between 19 November 2007 and 16 October 2008. A total of 154 participants were screened in the study.
Not provided
| 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 16. |
| FG001 | Rilonacept 160 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo (for Rilonacept) | Other | Placebo loading dose on Day 1 followed by single placebo injections (2 mL) qw for 17 weeks. |
|
| Day 1 (Baseline) to Day 84 (Week 12) |
| Mean Number of Gout Flares Per Month Per Participant From Day 1 to Day 84 (Week 12) | 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. Mean number of flares per month = (total number of flares observed)/ (total number of days subject was in the period/28 days). | Day 1 (Baseline) to Day 84 (Week 12) |
| Mean Number of Gout Flare Days Per Participant From Day 1 to Day 84 (Week 12) | 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. Mean number of gout flare days per participant was reported for this outcome measure. | Day 1 (Baseline) to Day 84 (Week 12) |
| Mean Number of Gout Flare Days Per Month Per Participant From Day 1 to Day 84 (Week 12) | 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. Mean number of gout flare days per month per participant was reported for this outcome measure. | Day 1 (Baseline) to Day 84 (Week 12) |
| Number of Gout Flare Days With Participant's Pain Score of 5 or More (From Daily Diary) Per Participant From Day 1 to Day 84 (Week 12) | Participants were asked to complete a telephone diary by calling the IVRS daily beginning at the baseline visit (Day 1) through the follow-up visit (Day 154) and reported their general well-being, gout symptoms, and weekly study drug administrations. At the onset of pain from a gout flare, participants were to answer additional diary questions regarding their gout flare and had to continue daily flare assessments until they reported the flare had ended. If a flare occurred just prior to the follow-up visit (Day 154), participants were to continue completing the daily diary until the flare resolved. Gout flare pain was assessed on a scale from 0 to 10 (with 0=no pain and 10=severe pain) within the past 24 hours. | Day 1 (Baseline) to Day 84 (Week 12) |
| Number of Gout Flare Days With Participant's Pain Score of 5 or More (From Daily Diary) Per Month Per Participant From Day 1 to Day 84 (Week 12) | Participants were asked to complete a telephone diary by calling the IVRS daily beginning at the baseline visit (Day 1) through the follow-up visit (Day 141) and reported their general well-being, gout symptoms, and weekly study drug administrations. At the onset of pain from a gout flare, participants were to answer additional diary questions regarding their gout flare and had to continue daily flare assessments until they reported the flare had ended. If a flare occurred just prior to the follow-up visit (Day 141), participants were to continue completing the daily diary until the flare resolved. Gout flare pain was assessed on a scale from 0 to 10 (with 0=no pain and 10=severe pain) within the past 24 hours. | Day 1 (Baseline) to Day 84 (Week 12) |
| Santa Maria |
| California |
| 93454 |
| United States |
| Whittier | California | 90601 | United States |
| Colorado Srings | Colorado | 80910 | United States |
| DeLand | Florida | 32720 | United States |
| Ocala | Florida | 34471 | United States |
| Orlando | Florida | 32804 | United States |
| St. Petersburg | Florida | 33710 | United States |
| Tampa | Florida | 33614 | United States |
| Tampa | Florida | United States |
| Dunwoody | Georgia | 30338 | United States |
| Honolulu | Hawaii | 96814 | United States |
| Boise | Idaho | 83702 | United States |
| Indianapolis | Indiana | 46268 | United States |
| South Bend | Indiana | 46601 | United States |
| Owensboro | Kentucky | 42303 | United States |
| Wheaton | Maryland | 20902 | United States |
| Billings | Montana | 59101 | United States |
| Omaha | Nebraska | 68114 | United States |
| Reno | Nevada | 89502 | United States |
| Albany | New York | 12206 | United States |
| Plainview | New York | 11803 | United States |
| Roslyn | New York | 11576 | United States |
| Monroe | North Carolina | 28112 | United States |
| Raleigh | North Carolina | 27612 | United States |
| Cincinnati | Ohio | 45242 | United States |
| Mayfield Village | Ohio | 44143 | United States |
| Oklahoma City | Oklahoma | 73112 | United States |
| Duncansville | Pennsylvania | 16635 | United States |
| West Reading | Pennsylvania | 19611 | United States |
| Charleston | South Carolina | 29406 | United States |
| Grenville | South Carolina | 29601 | United States |
| Dallas | Texas | 75235 | United States |
| Spokane | Washington | 99204 | United States |
| Derived |
| Khanna D, Sarkin AJ, Khanna PP, Shieh MM, Kavanaugh AF, Terkeltaub RA, Lee SJ, Singh JA, Hirsch JD. Minimally important differences of the gout impact scale in a randomized controlled trial. Rheumatology (Oxford). 2011 Jul;50(7):1331-6. doi: 10.1093/rheumatology/ker023. Epub 2011 Mar 3. |
Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
| 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 voice response system (IVRS) at randomization (as randomized).
Not provided
| 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 16. |
| BG001 | Rilonacept 160 mg | Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16. |
| 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 | Number of Gout Flares Per Participant Assessed From Day 1 to Day 84 (Week 12) | A gout flare was defined as participant reported 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. Number of gout flares per participant was reported for this outcome measure. For drop-outs, only flares occurred before Day 84 were counted, regardless whether the flares occurred during the treatment period or not. | Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized). | Posted | Mean | Standard Deviation | Number of gout flares per participant | Day 1 (Baseline) to Day 84 (Week 12) |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least One Gout Flare From Day 1 to Day 84 (Week 12) | 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 was reported for this outcome measure. | Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized). | Posted | Number | percentage of participants | Day 1 (Baseline) to Day 84 (Week 12) |
| |||||||||||||||||||||||||||||||
| Secondary | Mean Number of Gout Flares Per Month Per Participant From Day 1 to Day 84 (Week 12) | 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. Mean number of flares per month = (total number of flares observed)/ (total number of days subject was in the period/28 days). | Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized). | Posted | Mean | Standard Deviation | number of gout flares | Day 1 (Baseline) to Day 84 (Week 12) |
| ||||||||||||||||||||||||||||||
| Secondary | Mean Number of Gout Flare Days Per Participant From Day 1 to Day 84 (Week 12) | 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. Mean number of gout flare days per participant was reported for this outcome measure. | Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized). | Posted | Mean | Standard Deviation | Gout flare days | Day 1 (Baseline) to Day 84 (Week 12) |
|
| |||||||||||||||||||||||||||||
| Secondary | Mean Number of Gout Flare Days Per Month Per Participant From Day 1 to Day 84 (Week 12) | 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. Mean number of gout flare days per month per participant was reported for this outcome measure. | Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized). | Posted | Mean | Standard Deviation | Gout flare days | Day 1 (Baseline) to Day 84 (Week 12) |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Gout Flare Days With Participant's Pain Score of 5 or More (From Daily Diary) Per Participant From Day 1 to Day 84 (Week 12) | Participants were asked to complete a telephone diary by calling the IVRS daily beginning at the baseline visit (Day 1) through the follow-up visit (Day 154) and reported their general well-being, gout symptoms, and weekly study drug administrations. At the onset of pain from a gout flare, participants were to answer additional diary questions regarding their gout flare and had to continue daily flare assessments until they reported the flare had ended. If a flare occurred just prior to the follow-up visit (Day 154), participants were to continue completing the daily diary until the flare resolved. Gout flare pain was assessed on a scale from 0 to 10 (with 0=no pain and 10=severe pain) within the past 24 hours. | Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized). | Posted | Mean | Standard Deviation | Gout flare days | Day 1 (Baseline) to Day 84 (Week 12) |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Gout Flare Days With Participant's Pain Score of 5 or More (From Daily Diary) Per Month Per Participant From Day 1 to Day 84 (Week 12) | Participants were asked to complete a telephone diary by calling the IVRS daily beginning at the baseline visit (Day 1) through the follow-up visit (Day 141) and reported their general well-being, gout symptoms, and weekly study drug administrations. At the onset of pain from a gout flare, participants were to answer additional diary questions regarding their gout flare and had to continue daily flare assessments until they reported the flare had ended. If a flare occurred just prior to the follow-up visit (Day 141), participants were to continue completing the daily diary until the flare resolved. Gout flare pain was assessed on a scale from 0 to 10 (with 0=no pain and 10=severe pain) within the past 24 hours. | Full analysis set (FAS) that included all randomized participants who received any study medication and was based on treatment allocated by IVRS at randomization (as randomized). | Posted | Mean | Standard Deviation | Gout flare days | Day 1 (Baseline) to Day 84 (Week 12) |
|
Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 22) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug through the period ending 42 days after the last dose of study drug). Analysis was performed on safety population the included all participants who received any study medication and were analyzed according to the treatment actually received (as treated).
Not provided
| 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 16. | 2 | 42 | 8 | 42 | ||
| EG001 | Rilonacept 160 mg | Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16. | 1 | 41 | 6 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | meddra (10) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | meddra (10) | Systematic Assessment |
| |
| Blood urea increased | Investigations | meddra (10) | Systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | meddra (10) | Systematic Assessment |
| |
| Protein urine present | Investigations | meddra (10) | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra (10) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | meddra (10) | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | meddra (10) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | meddra (10) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | meddra (10) | 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C531377 | rilonacept |
Not provided
Not provided
Not provided
| 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 |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
|