Clinical trial NCT00856206: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: 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
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-03-05
Enrollment: 1315
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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;;;

Primary outcomes:
measure: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Baseline up to Week 20
Secondary outcomes:
measure: Number of Gout Flares Per Participant Assessed From Day 1 to Day 112 (Week 16)
timeFrame: Day 1 to Day 112 (Week 16)
measure: Percentage of Participants With at Least One Flare From Day 1 to Day 112 (Week 16)
timeFrame: Day 1 to Day 112 (Week 16)
measure: Percentage of Participants With at Least Two Flares From Day 1 to Day 112 (Week 16)
timeFrame: Day 1 to Day 112 (Week 16)
measure: Number of Gout Flare Days Per Participant From Day 1 to Day 112 (Week 16)
timeFrame: Day 1 to Day 112 (Week 16)
Other outcomes:
Locations:
city: Alabaster
country: United States
state: Alabama
city: Mesa
country: United States
state: Arizona
city: Burbank
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Upland
country: United States
state: California
city: Brooksville
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Debary
country: United States
state: Florida
city: Deland
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: Palm Harbor
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Canton
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Sandy Springs
country: United States
state: Georgia
city: Stockbridge
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Brownsburg
country: United States
state: Indiana
city: Evansville
country: United States
state: Indiana
city: Greenfield
country: United States
state: Indiana
city: Bowling Green
country: United States
state: Kentucky
city: Elizabethtown
country: United States
state: Kentucky
city: Lexington
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Springfield
country: United States
state: Massachusetts
city: Worcester
country: United States
state: Massachusetts
city: Bingham Farms
country: United States
state: Michigan
city: Brooklyn Center
country: United States
state: Minnesota
city: Richmond Heights
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Billings
country: United States
state: Montana
city: Kalispell
country: United States
state: Montana
city: Lincoln
country: United States
state: Nebraska
city: Elizabeth
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Brooklyn
country: United States
state: New York
city: Mineola
country: United States
state: New York
city: New York
country: United States
state: New York
city: Roslyn
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Hickory
country: United States
state: North Carolina
city: Mooresville
country: United States
state: North Carolina
city: Morganton
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Middleburg Heights
country: United States
state: Ohio
city: Duncansville
country: United States
state: Pennsylvania
city: Morrisville
country: United States
state: Pennsylvania
city: Ridley Park
country: United States
state: Pennsylvania
city: Willow Grove
country: United States
state: Pennsylvania
city: Anderson
country: United States
state: South Carolina
city: Monck's Corner
country: United States
state: South Carolina
city: Orangeburg
country: United States
state: South Carolina
city: Johnson City
country: United States
state: Tennessee
city: Arlington
country: United States
state: Texas
city: Carrollton
country: United States
state: Texas
city: Corsicana
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Lake Jackson
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Southlake
country: United States
state: Texas
city: Sugarland
country: United States
state: Texas
city: Ogden
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: West Jordan
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Oak Creek
country: United States
state: Wisconsin
city: Wauwatosa
country: United States
state: Wisconsin
city: Kuenzing
country: Germany
state: BY
city: Dietzenbach
country: Germany
state: HE
city: Hamburg
country: Germany
state: HH
city: Essen
country: Germany
state: NW
city: Goch
country: Germany
state: NW
city: Siegen
country: Germany
state: NW
city: Rhaunen
country: Germany
state: RP
city: Secundrabad
country: India
state: Andh Prad
city: New Dehli
country: India
state: Delhi
city: Ahmedabad
country: India
state: Gujarat
city: Gandhinagar
country: India
state: Gujarat
city: Bangalore
country: India
state: Karna
city: Mangalore
country: India
state: Karna
city: Mumbai
country: India
state: Mahara
city: Kolkatta
country: India
state: W Bengal
city: Denpasar
country: Indonesia
state: Bali
city: Makassar
country: Indonesia
state: South Sulawesi
city: Padang
country: Indonesia
state: West Sumatra
city: Bandung
country: Indonesia
city: Daerah Istimewa Yogyakarta
country: Indonesia
city: Malang
country: Indonesia
city: South Sumatra
country: Indonesia
city: Port Elizabeth
country: South Africa
state: E Cape
city: Bloemfontein
country: South Africa
state: Free State
city: Benoni
country: South Africa
state: Gauteng
city: Centurion
country: South Africa
state: Gauteng
city: Eldoraigne
country: South Africa
state: Gauteng
city: Johannesburg
country: South Africa
state: Gauteng
city: Kempton Park
country: South Africa
state: Gauteng
city: Krugersdorp
country: South Africa
state: Gauteng
city: Lenasia
country: South Africa
state: Gauteng
city: Limpopo
country: South Africa
state: Gauteng
city: Pretoria
country: South Africa
state: Gauteng
city: Rustenburg
country: South Africa
state: Gauteng
city: Soweto
country: South Africa
state: Gauteng
city: Dundee
country: South Africa
state: KZ-Natal
city: Durban North
country: South Africa
state: KZ-Natal
city: Phoenix
country: South Africa
state: KZ-Natal
city: Verulam
country: South Africa
state: KZ-Natal
city: Breyten
country: South Africa
state: Mpumalanga
city: Durban
country: South Africa
state: Mpumalanga
city: Cape Town
country: South Africa
state: W Cape
city: Mpumalanga
country: South Africa
city: Changhua
country: Taiwan
city: Hualien
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Robert Evans, PharmD
role: STUDY_DIRECTOR
References:
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.