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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-007762-39 | EudraCT Number |
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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 participants with gout who are beginning allopurinol treatment for gout. Participants will participate in this study for approximately 22 weeks. Rilonacept was 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 | 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 15. |
|
| 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 15. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo loading dose followed by placebo subcutaneous (SC) injection (2 mL) once a week for 16 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Gout Flares Per Participant Assessed From Day 1 to Day 113 (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 flares per participant was reported for this outcome measure. | Day 1 to Day 113 (Week 16) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Modified Gout Flares Per Participant From Day 1 to Day 113 (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 113 (Week 16) |
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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 |
|---|---|---|---|---|---|---|
| Berlin | Germany | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23485476 | Derived | Mitha E, Schumacher HR, Fouche L, Luo SF, Weinstein SP, Yancopoulos GD, Wang J, King-Davis S, Evans RR. Rilonacept for gout flare prevention during initiation of uric acid-lowering therapy: results from the PRESURGE-2 international, phase 3, randomized, placebo-controlled trial. Rheumatology (Oxford). 2013 Jul;52(7):1285-92. doi: 10.1093/rheumatology/ket114. Epub 2013 Mar 13. |
| Label | URL |
|---|---|
| Rilonacept | View source |
Not provided
Out of 471 participants, 248 were randomized and treated in the study. Participants were randomized in 1:1:1 ratio to receive Placebo or Rilonacept 80 mg or Rilonacept 160 mg.
The study was conducted at 57 study sites in European Union (EU) and rest of world (ROW) between 7 March 2009 and 17 December 2010. A total of 471 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 | Drug | Rilonacept 160 mg SC loading dose followed by Rilonacept 80 mg/2 mL SC injections once a week for 16 weeks. |
|
| Rilonacept | Drug | Rilonacept 320 mg SC loading dose followed by Rilonacept 160 mg/2 mL SC injections once a week for 16 weeks. |
|
| Percentage of Participants With at Least One Flare From Day 1 to Day 113 (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 113 (Week 16) |
| Percentage of Participants With at Least Two Flares From Day 1 to Day 113 (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 113 (Week 16) |
| Number of Gout Flare Days Per Participant From Day 1 to Day 113 (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 113 (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 113 (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 113 (Week 16) |
| Essen |
| Germany |
| Goch | Germany |
| Hamburg | Germany |
| Kassel | Germany |
| Künzing | Germany |
| Lollar | Germany |
| Magdeburg | Germany |
| München | Germany |
| Rhaunen | Germany |
| Siegen | Germany |
| Ahmedabad | India |
| Bangalore | India |
| Gandhinagar | India |
| Hyderabaad | India |
| Kolkata | India |
| Mangalore | India |
| Pune | India |
| Secunderabad | India |
| Vadodara | India |
| Varanasi | India |
| Denpasar | Indonesia |
| Jakarta | Indonesia |
| Kemerdekaan | Indonesia |
| Palembang | Indonesia |
| Semarang | Indonesia |
| South Sulawesi | Indonesia |
| West Java | Indonesia |
| Yogyakarta | Indonesia |
| Benoni | South Africa |
| Bloemfontein | South Africa |
| Breyten | South Africa |
| Cape Town | South Africa |
| Dundee | South Africa |
| Durban | South Africa |
| Durban North | South Africa |
| eManzimtoti | South Africa |
| Gauteng | South Africa |
| Johannesburg | South Africa |
| Kempton Park | South Africa |
| Krugersdorp | South Africa |
| KZ-Natal | South Africa |
| Lenasia | South Africa |
| Lyttleton | South Africa |
| Middleburg | South Africa |
| Port Elizabeth | South Africa |
| Pretoria | South Africa |
| Roodepoort | South Africa |
| Scottburgh | South Africa |
| Somerset West | South Africa |
| Soweto | South Africa |
| Worcester | South Africa |
| Yungkang City | Tainan | Taiwan |
| Changhua | Taiwan |
| Dalin Town | Taiwan |
| Hualien City | Taiwan |
| Kaohsiung City | Taiwan |
| Kwei-Shan | Taiwan |
| Taichung | Taiwan |
| Tainan | Taiwan |
| Taipei | Taiwan |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Baseline population included all randomized participants.
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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 once a week (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 113 (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 flares 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 the Interactive voice response system (IVRS) at randomization (as randomized). Here, number of participants analyzed=participants with available data for this endpoint. | Posted | Mean | Standard Deviation | Gout flares | Day 1 to Day 113 (Week 16) |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Modified Gout Flares Per Participant From Day 1 to Day 113 (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. | FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by the IVRS at randomization (as randomized). Here, number of participants analyzed=participants with available data for this endpoint. | Posted | Mean | Standard Deviation | Gout flares | Day 1 to Day 113 (Week 16) |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least One Flare From Day 1 to Day 113 (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. | FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by the IVRS at randomization (as randomized). | Posted | Number | percentage of participants | Day 1 to Day 113 (Week 16) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least Two Flares From Day 1 to Day 113 (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. | FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by the IVRS at randomization (as randomized). | Posted | Number | percentage of participants | Day 1 to Day 113 (Week 16) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Gout Flare Days Per Participant From Day 1 to Day 113 (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. | FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by the IVRS at randomization (as randomized). Here, number of participants analyzed=participants with available data for this endpoint. | Posted | Mean | Standard Deviation | Gout flare days | Day 1 to Day 113 (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 113 (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. | FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by IVRS at randomization (as randomized). Here, number of participants analyzed=participants with available data for this endpoint. | Posted | Mean | Standard Deviation | Gout flare days | Day 1 to Day 113 (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).
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. | 4 | 82 | 12 | 82 | ||
| 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. | 5 | 82 | 20 | 82 | ||
| 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 | 84 | 20 | 84 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cor pulmonale | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Umbilical hernia, obstructive | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hypertension | Vascular 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 |
| |
| Influenza | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | 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. | clinicaltrials@regeneron.com |
| ID | Term |
|---|---|
| D006073 | Gout |
| 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 |
| ID | Term |
|---|---|
| D000070657 | Crystal Arthropathies |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009750 | Nutritional and Metabolic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue 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 |
|
|
|
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. |
|
|