Clinical trial NCT00829829: PREventative Study Against URate-lowering Drug-induced Gout Exacerbations 1
Official title: A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Rilonacept for the Prophylaxis of Gout Flares During the Initiation of Allopurinol Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Intercritical Gout
Keywords: Metabolism, Inborn Errors
Allopurinol
Metabolic Diseases
Genetic Diseases, Inborn
Musculoskeletal Diseases
Joint Diseases
Arthritis
Rheumatic Diseases
Metabolic disorder
Purine-Pyrimidine Metabolism, Inborn Errors
Gout
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-01-27
Enrollment: 241
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: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Male or female 18 to 80 years of age;
* Previously met the preliminary criteria of the American Rheumatism Association (ARA) for the classification; of the acute arthritis of primary gout;
* At least 2 gout flares in the year prior to the screening visit;
* Serum uric acid greater than or equal to 7.5 mg/dL at the screening visit;

Exclusion Criteria:

* Acute gout flare within 2 weeks of the screening visit or during screening;
* Persistent chronic or active infections;
* History of an allergic reaction to allopurinol;
* History or presence of cancer within 5 years of the screening visit;
* Previous exposure to Rilonacept;
* Use of allopurinol, benzbromarone, febuxostat, probenecid or sulfinpyrazone within 3 months prior to the screening visit.

Primary 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)
Secondary outcomes:
measure: Number of Modified Gout Flares Per Participant From Day 1 to Day 112 (Week 16)
timeFrame: Day 1 to Day 112 (Week 16)
measure: Percentage of Participants With at Least One Gout 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 Gout 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)
measure: 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)
timeFrame: Day 1 to Day 112 (Week 16)
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Gilbert
country: United States
state: Arizona
city: Peoria
country: United States
state: Arizona
city: Searcy
country: United States
state: Arkansas
city: Concord
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Maria
country: United States
state: California
city: Trumball
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Daytona Beach
country: United States
state: Florida
city: Delray Beach
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Jupiter
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Gainsville
country: United States
state: Georgia
city: Rome
country: United States
state: Georgia
city: Tucker
country: United States
state: Georgia
city: Woodstock
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Avon
country: United States
state: Indiana
city: Evansville
country: United States
state: Indiana
city: South Bend
country: United States
state: Indiana
city: Wichita
country: United States
state: Kansas
city: Bowling Green
country: United States
state: Kentucky
city: Owensboro
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Ellicott City
country: United States
state: Maryland
city: Resistertown
country: United States
state: Maryland
city: Troy
country: United States
state: Michigan
city: Jackson
country: United States
state: Mississippi
city: Florissant
country: United States
state: Missouri
city: Las Vegas
country: United States
state: Nevada
city: Las Vegas
country: United States
state: Nevada
city: Berkeley Heights
country: United States
state: New Jersey
city: Freehold
country: United States
state: New Jersey
city: Brooklyn
country: United States
state: New York
city: Greensboro
country: United States
state: North Carolina
city: Hickory
country: United States
state: North Carolina
city: Morehead City
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Salisbury
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Middleburg Heights
country: United States
state: Ohio
city: Perrysburg
country: United States
state: Ohio
city: Duncansville
country: United States
state: Pennsylvania
city: Fountain Hill
country: United States
state: Pennsylvania
city: Huntingdon Valley
country: United States
state: Pennsylvania
city: Lancaster
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Columbia
country: United States
state: South Carolina
city: Greer
country: United States
state: South Carolina
city: North Charleston
country: United States
state: South Carolina
city: Rock Hill
country: United States
state: South Carolina
city: Memphis
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Longview
country: United States
state: Texas
city: Richardson
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Burke
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Calgary
country: Canada
state: Alberta
city: Burnaby
country: Canada
state: British Columbia
city: Kamloops
country: Canada
state: British Columbia
city: Kelowna
country: Canada
state: British Columbia
city: Quesnel
country: Canada
state: British Columbia
city: Victoria
country: Canada
state: British Columbia
city: Mt. Pearl
country: Canada
state: Newfoundland and Labrador
city: St. John's
country: Canada
state: Newfoundland and Labrador
city: Brampton
country: Canada
state: Ontario
city: Corunna
country: Canada
state: Ontario
city: Fort Erie
country: Canada
state: Ontario
city: Kitchener
country: Canada
state: Ontario
city: Listowel
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Mississauga
country: Canada
state: Ontario
city: Newmarket
country: Canada
state: Ontario
city: Sudbury
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Trois-Rivieres
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
city: Quebec
country: Canada
Study officials:
References:
citation: 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.