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The purpose of this clinical research study was to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are beginning allopurinol treatment for gout. Subjects will participate in this study for approximately 22 weeks. Rilonacept is being studied for use in preventing allopurinol-induced gout flares.
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| 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 15. |
|
| Rilonacept 80 mg | Active Comparator | 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 15. |
|
| Rilonacept 160 mg | Active Comparator | 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 15. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Placebo loading dose followed by placebo injections (2 mL) qw for 16 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Gout Flares Per Participant Assessed From Day 1 to Day 112 (Week 16) | 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 112 were counted, regardless whether the flares occurred during the treatment period or not. | Day 1 to Day 112 (Week 16) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Modified Gout Flares Per Participant From Day 1 to Day 112 (Week 16) | Modified gout flare was defined using modified definition of a gout flare as participant-reported articular pain typical of a gout attack that was deemed to require treatment with anti-inflammatory therapy. Number of modified gout flares per participant were reported for this outcome measure. | Day 1 to Day 112 (Week 16) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35294 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22549879 | Derived | Schumacher HR Jr, Evans RR, Saag KG, Clower J, Jennings W, Weinstein SP, Yancopoulos GD, Wang J, Terkeltaub R. Rilonacept (interleukin-1 trap) for prevention of gout flares during initiation of uric acid-lowering therapy: results from a phase III randomized, double-blind, placebo-controlled, confirmatory efficacy study. Arthritis Care Res (Hoboken). 2012 Oct;64(10):1462-70. doi: 10.1002/acr.21690. |
| Label | URL |
|---|---|
| Rilonacept | View source |
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Out of 468 participants, 241 were randomized and 240 treated in the study. Participants were randomized in 1:1:1 ratio to receive either Placebo or Rilonacept 80 mg or Rilonacept 160 mg.
The study was conducted at 49 study sites in Unites States (US) and 15 study sites in Canada between 5 March 2009 and 18 May 2010. A total of 468 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 15. |
| FG001 | Rilonacept 80 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Rilonacept 80 mg |
| Drug |
Rilonacept 160 mg loading dose followed by Rilonacept 80 mg/2 mL injections qw for 16 weeks. |
|
| Rilonacept 160 mg | Drug | Rilonacept 320 mg loading dose followed by Rilonacept 160 mg/2 mL injections qw for 16 weeks. |
|
| Percentage of Participants With at Least One Gout Flare From Day 1 to Day 112 (Week 16) | 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. | Day 1 to Day 112 (Week 16) |
| Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 112 (Week 16) | 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 was reported for this outcome measure. | Day 1 to Day 112 (Week 16) |
| Number of Gout Flare Days Per Participant From Day 1 to Day 112 (Week 16) | 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. Number of gout flare days per participant was reported for this outcome measure. | Day 1 to Day 112 (Week 16) |
| Number of Gout Flare Days With Participant's Pain Score of 5 or More (From Daily Diary) Per Participant From Day 1 to Day 112 (Week 16) | 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 to Day 112 (Week 16) |
| Gilbert |
| Arizona |
| 85296 |
| United States |
| Peoria | Arizona | 85381 | United States |
| Searcy | Arkansas | 72143 | United States |
| Concord | California | 94520 | United States |
| San Diego | California | 92103 | United States |
| Santa Maria | California | 93454 | United States |
| Trumball | Connecticut | 06611 | United States |
| Washington D.C. | District of Columbia | 20003 | United States |
| Daytona Beach | Florida | 32117 | United States |
| Delray Beach | Florida | 33446 | United States |
| Jacksonville | Florida | 32205 | United States |
| Jupiter | Florida | 33458 | United States |
| Naples | Florida | 34102 | United States |
| St. Petersburg | Florida | 33702 | United States |
| Gainsville | Georgia | 30501 | United States |
| Rome | Georgia | 30165 | United States |
| Tucker | Georgia | 30084 | United States |
| Woodstock | Georgia | 30188 | United States |
| Boise | Idaho | 83713 | United States |
| Avon | Indiana | 46123 | United States |
| Evansville | Indiana | 47714 | United States |
| South Bend | Indiana | 46601 | United States |
| Wichita | Kansas | 67208 | United States |
| Bowling Green | Kentucky | 42101 | United States |
| Owensboro | Kentucky | 42303 | United States |
| Baltimore | Maryland | 21286 | United States |
| Ellicott City | Maryland | 21042 | United States |
| Resistertown | Maryland | 01136 | United States |
| Troy | Michigan | 48098 | United States |
| Jackson | Mississippi | 39202 | United States |
| Florissant | Missouri | 63031 | United States |
| Las Vegas | Nevada | 89123 | United States |
| Las Vegas | Nevada | 89146 | United States |
| Berkeley Heights | New Jersey | 07922 | United States |
| Freehold | New Jersey | 07728 | United States |
| Brooklyn | New York | 11201 | United States |
| Greensboro | North Carolina | 27408 | United States |
| Hickory | North Carolina | 28601 | United States |
| Morehead City | North Carolina | 28516 | United States |
| Raleigh | North Carolina | 27607 | United States |
| Raleigh | North Carolina | 27612 | United States |
| Salisbury | North Carolina | 28144 | United States |
| Akron | Ohio | 44313 | United States |
| Cincinnati | Ohio | 45246 | United States |
| Middleburg Heights | Ohio | 44130 | United States |
| Perrysburg | Ohio | 43551 | United States |
| Duncansville | Pennsylvania | 16635 | United States |
| Fountain Hill | Pennsylvania | 18105 | United States |
| Huntingdon Valley | Pennsylvania | 19006 | United States |
| Lancaster | Pennsylvania | 17601 | United States |
| Charleston | South Carolina | 29406 | United States |
| Columbia | South Carolina | 29204 | United States |
| Greer | South Carolina | 29651 | United States |
| North Charleston | South Carolina | 29406 | United States |
| Rock Hill | South Carolina | 29732 | United States |
| Memphis | Tennessee | 38120 | United States |
| Dallas | Texas | 75224 | United States |
| Dallas | Texas | 75231 | United States |
| Houston | Texas | 77074 | United States |
| Longview | Texas | 75605 | United States |
| Richardson | Texas | 75080 | United States |
| San Antonio | Texas | 78229 | United States |
| Burke | Virginia | 22015 | United States |
| Richmond | Virginia | 23219 | United States |
| Spokane | Washington | 99204 | United States |
| Tacoma | Washington | 98405 | United States |
| Calgary | Alberta | T2X3X7 | Canada |
| Burnaby | British Columbia | V5G1T4 | Canada |
| Kamloops | British Columbia | V2C1K7 | Canada |
| Kelowna | British Columbia | V1Y3G8 | Canada |
| Quesnel | British Columbia | V2J2K3 | Canada |
| Victoria | British Columbia | V8R 6V4 | Canada |
| Mount Pearl | Newfoundland and Labrador | A1N1W7 | Canada |
| St. John's | Newfoundland and Labrador | A1E2E2 | Canada |
| Brampton | Ontario | L6W3E1 | Canada |
| Corunna | Ontario | N0N1G0 | Canada |
| Fort Erie | Ontario | L2A1Z3 | Canada |
| Greater Sudbury | Ontario | P3E1H5 | Canada |
| Kitchener | Ontario | N2M5N6 | Canada |
| Listowel | Ontario | N4W2P4 | Canada |
| London | Ontario | N5Z3L2 | Canada |
| London | Ontario | N6B2E5 | Canada |
| Mississauga | Ontario | L5M2V8 | Canada |
| Newmarket | Ontario | L3Y5G8 | Canada |
| Toronto | Ontario | M9W4L6 | Canada |
| Windsor | Ontario | N8X5A6 | Canada |
| Montreal | Quebec | H1T2M4 | Canada |
| Québec | Quebec | G1V3M7 | Canada |
| Trois-Rivières | Quebec | G8Z1YZ | Canada |
| Saskatoon | Saskatchewan | S7K0H6 | Canada |
| Allopurinol | View source |
| Allopurinol sodium | View source |
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 15.
| FG002 | 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 15. |
| Treated | Participants treated were included in safety population. |
|
| 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 15. |
| 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 15. |
| BG002 | 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 15. |
| 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 |
| ||||||||||||||||
| 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 112 (Week 16) | 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 112 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 the treatment allocated by IIVRS at randomization (as randomized). | Posted | Mean | Standard Deviation | Number of Gout flares per participant | Day 1 to Day 112 (Week 16) |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Modified Gout Flares Per Participant From Day 1 to Day 112 (Week 16) | Modified gout flare was defined using modified definition of a gout flare as participant-reported articular pain typical of a gout attack that was deemed to require treatment with anti-inflammatory therapy. Number of modified gout flares per participant were reported for this outcome measure. | Full analysis set (FAS) that included all randomized participants who received any study medication and was based on the treatment allocated by IVRS at randomization (as randomized). | Posted | Mean | Standard Deviation | modified gout flares | Day 1 to Day 112 (Week 16) |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least One Gout Flare From Day 1 to Day 112 (Week 16) | 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 the treatment allocated by IIVRS at randomization (as randomized). | Posted | Number | percentage of participants | Day 1 to Day 112 (Week 16) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 112 (Week 16) | 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 was reported for this outcome measure. | Full analysis set (FAS) that included all randomized participants who received any study medication and was based on the treatment allocated by IIVRS at randomization (as randomized). | Posted | Number | percentage of participants | Day 1 to Day 112 (Week 16) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Gout Flare Days Per Participant From Day 1 to Day 112 (Week 16) | 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. 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 the treatment allocated by IIVRS at randomization (as randomized). | Posted | Mean | Standard Deviation | Gout flare Days | Day 1 to Day 112 (Week 16) |
| |||||||||||||||||||||||||||||||||
| 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 112 (Week 16) | 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 the treatment allocated by IIVRS at randomization (as randomized). | Posted | Mean | Standard Deviation | Gout flare days | Day 1 to Day 112 (Week 16) |
|
Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) 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 35 days after the last dose of study drug). Analysis was performed on safety population included all participants who received any study medication and was based on the treatment received.
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 15. | 3 | 79 | 8 | 79 | ||
| 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 15. | 3 | 80 | 16 | 80 | ||
| EG002 | 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 15. | 3 | 81 | 17 | 81 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Abdominal hernia obstructive | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (12.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 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 |
|
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. Phone: | 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 |
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 |
|
|
|
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 15.
|
|
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 15.
|
|
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 15.
|
|
| OG002 | 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 15. |
|
|