Back to resultsReview of Safety Using Rilonacept in Preventing Gout Exacerbations (RE-SURGE)
Primary Purpose
Gout
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rilonacept
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Gout focused on measuring Metabolism, Inborn Errors, Allopurinol, Metabolic Disease, Genetic Diseases, Inborn, Musculoskeletal Diseases, Joint Diseases, Arthritis, Rheumatic Diseases, Metabolic disorder, Purine Pyrimidine Metabolism, Inborn Errors, Gout, Intercritical Gout
Eligibility Criteria
Inclusion Criteria:
- Male or female 18 to 80 years of age;
- Previously met the preliminary criteria of American Rheumatism Associatio (ARA) for the classification of acute gout arthritis of primary gout;
- Subjects with history of gout, initiating or currently on urate lowering; therapy who are at risk of gout flare.
Exclusion Criteria:
- Acute gout flare within 2 weeks prior to the screening visit and during the screening visit;
- Persistent chronic or active infections;
- History of an allergic reaction to allopurinol;
- History or presence of cancer within 5 years of the Screening Visit;;;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Rilonacept 160 mg
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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. Treatment-emergent adverse events (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 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.
Secondary Outcome Measures
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.
Percentage of Participants With at Least One Flare 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. Percentage of participants with at least one gout flare 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.
Percentage of Participants With at Least Two Flares 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. Percentage of participants with at least two gout flare 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.
Number of Gout Flare Days Per Participant 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. Flare days were counted up to Week 16, regardless of whether or not the flares occurred during the treatment period.
Full Information
NCT ID
NCT00856206
First Posted
February 21, 2009
Last Updated
March 20, 2017
Sponsor
Regeneron Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00856206
Brief Title
Review of Safety Using Rilonacept in Preventing Gout Exacerbations (RE-SURGE)
Official Title
A Multi-Center, Randomized, Double-Blind, Placebo Controlled Trial of the Safety of Rilonacept for the Prophylaxis of Gout Flares in Patients on Urate- Lowering Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this clinical research study is to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are on urate-lowering therapy. Subjects will participate in this study for approximately 20 weeks. Rilonacept is being studied for use in preventing gout flares in subjects on urate-lowering therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout
Keywords
Metabolism, Inborn Errors, Allopurinol, Metabolic Disease, Genetic Diseases, Inborn, Musculoskeletal Diseases, Joint Diseases, Arthritis, Rheumatic Diseases, Metabolic disorder, Purine Pyrimidine Metabolism, Inborn Errors, Gout, Intercritical Gout
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1315 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Rilonacept 160 mg
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Rilonacept
Intervention Description
Rilonacept 160 mg subcutaneous injection once a week
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo subcutaneous injection once a week
Primary Outcome Measure Information:
Title
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Description
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. Treatment-emergent adverse events (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 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.
Time Frame
Baseline up to Week 20
Secondary Outcome Measure Information:
Title
Number of Gout Flares Per Participant Assessed From Day 1 to Day 112 (Week 16)
Description
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.
Time Frame
Day 1 to Day 112 (Week 16)
Title
Percentage of Participants With at Least One Flare From Day 1 to Day 112 (Week 16)
Description
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. Percentage of participants with at least one gout flare 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.
Time Frame
Day 1 to Day 112 (Week 16)
Title
Percentage of Participants With at Least Two Flares From Day 1 to Day 112 (Week 16)
Description
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. Percentage of participants with at least two gout flare 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.
Time Frame
Day 1 to Day 112 (Week 16)
Title
Number of Gout Flare Days Per Participant From Day 1 to Day 112 (Week 16)
Description
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. Flare days were counted up to Week 16, regardless of whether or not the flares occurred during the treatment period.
Time Frame
Day 1 to Day 112 (Week 16)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female 18 to 80 years of age;
Previously met the preliminary criteria of American Rheumatism Associatio (ARA) for the classification of acute gout arthritis of primary gout;
Subjects with history of gout, initiating or currently on urate lowering; therapy who are at risk of gout flare.
Exclusion Criteria:
Acute gout flare within 2 weeks prior to the screening visit and during the screening visit;
Persistent chronic or active infections;
History of an allergic reaction to allopurinol;
History or presence of cancer within 5 years of the Screening Visit;;;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Evans, PharmD
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Alabaster
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Mesa
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Burbank
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Carrollton
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West Jordan
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Norfolk
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Richmond
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Wauwatosa
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Kuenzing
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BY
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Germany
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Dietzenbach
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HE
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Germany
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Hamburg
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HH
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Germany
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Essen
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NW
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Germany
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Goch
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Germany
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Siegen
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Germany
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Rhaunen
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RP
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Germany
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Secundrabad
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Andh Prad
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India
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New Dehli
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Delhi
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India
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Ahmedabad
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India
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Gandhinagar
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India
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Bangalore
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Karna
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India
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Mangalore
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Karna
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India
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Mumbai
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Mahara
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India
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Kolkatta
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W Bengal
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India
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Denpasar
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Bali
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Indonesia
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Makassar
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South Sulawesi
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Indonesia
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Padang
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West Sumatra
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Indonesia
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Bandung
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Indonesia
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Daerah Istimewa Yogyakarta
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Indonesia
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Malang
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Indonesia
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South Sumatra
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Indonesia
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Port Elizabeth
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E Cape
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South Africa
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Bloemfontein
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Free State
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Benoni
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Gauteng
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South Africa
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Centurion
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South Africa
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Eldoraigne
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Gauteng
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South Africa
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Johannesburg
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Gauteng
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Kempton Park
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Gauteng
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Krugersdorp
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Gauteng
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South Africa
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Lenasia
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Gauteng
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Limpopo
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Gauteng
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Pretoria
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Gauteng
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Rustenburg
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Gauteng
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Soweto
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Gauteng
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Dundee
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KZ-Natal
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South Africa
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Durban North
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KZ-Natal
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South Africa
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Phoenix
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South Africa
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Verulam
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South Africa
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Breyten
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Mpumalanga
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South Africa
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Durban
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Mpumalanga
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South Africa
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Cape Town
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W Cape
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South Africa
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Mpumalanga
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South Africa
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Changhua
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Taiwan
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Hualien
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Taiwan
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Tainan
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Taiwan
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Taipei
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Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
25028379
Citation
Sundy JS, Schumacher HR, Kivitz A, Weinstein SP, Wu R, King-Davis S, Evans RR. Rilonacept for gout flare prevention in patients receiving uric acid-lowering therapy: results of RESURGE, a phase III, international safety study. J Rheumatol. 2014 Aug;41(8):1703-11. doi: 10.3899/jrheum.131226. Epub 2014 Jul 15.
Results Reference
derived
Learn more about this trial
Review of Safety Using Rilonacept in Preventing Gout Exacerbations (RE-SURGE)
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