Clinical trial NCT01459796: Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Gout
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-10-26
Enrollment: 220
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 study was to determine the safety and tolerability of rilonacept for participants with gout who were initiating allopurinol.


Eligibility criteria: Inclusion Criteria:

Key Inclusion criteria:

* Male or female participants aged 18 to 80 years;
* Previously met the preliminary criteria of the ARA for the classification of the acute arthritis of primary gout;
* Serum uric acid greater than or equal to 7.5 mg/dL at the screening visit;
* A self-reported history of at least 2 gout flares in the year prior to screening.

Exclusion Criteria:

Key Exclusion criteria:

* Pregnant or nursing, or planning to become pregnant or father a child within 3 months after receiving the last dose of study drug;
* Participants requiring dialysis;
* Participants who had had an organ transplant;
* Persistent chronic or active infections;
* Previous exposure to rilonacept;
* Use of allopurinol, benzbromarone, febuxostat, probenecid or sulfinpyrazone within 84 days prior to the screening visit.

Primary outcomes:
measure: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: Day 1 to Day 392 (Week 56)
Secondary outcomes:
measure: Percentage of Participants With at Least One Gout Flare From Day 1 to Day 168 (Week 24)
timeFrame: Day 1 to Day 168 (Week 24)
measure: Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 168 (Week 24)
timeFrame: Day 1 to Day 168 (Week 24)
measure: Percentage of Participants With at Least One Gout Flare From Day 1 to Day 364 (Week 52)
timeFrame: Day 1 to Day 364 (Week 52)
measure: Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 364 (Week 52)
timeFrame: Day 1 to Day 364 (Week 52)
measure: Percentage of Participants With Rescue Medication From Day 1 to Day 364 (Week 52)
timeFrame: Day 1 to Day 364 (Week 52)
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Mesa
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Sierra Vista
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Searcy
country: United States
state: Arkansas
city: Concord
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Whittier
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Trumbull
country: United States
state: Connecticut
city: Washington, D.C.
country: United States
state: District of Columbia
city: Clearwater
country: United States
state: Florida
city: DeLand
country: United States
state: Florida
city: Delray Beach
country: United States
state: Florida
city: New Port Richey
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Saint Petersburg
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Venice
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Coeur d'Alene
country: United States
state: Idaho
city: Meridian
country: United States
state: Idaho
city: Avon
country: United States
state: Indiana
city: Brownsburg
country: United States
state: Indiana
city: Evansville
country: United States
state: Indiana
city: Bowling Green
country: United States
state: Kentucky
city: Elizabethtown
country: United States
state: Kentucky
city: Owensboro
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Cumberland
country: United States
state: Maryland
city: Hagerstown
country: United States
state: Maryland
city: Wheaton
country: United States
state: Maryland
city: Fall River
country: United States
state: Massachusetts
city: Edina
country: United States
state: Minnesota
city: Saint Louis
country: United States
state: Missouri
city: Kalispell
country: United States
state: Montana
city: Omaha
country: United States
state: Nebraska
city: Brooklyn
country: United States
state: New York
city: Cary
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Greensboro
country: United States
state: North Carolina
city: Greenville
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Salisbury
country: United States
state: North Carolina
city: Statesville
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Carlisle
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Huntingdon Valley
country: United States
state: Pennsylvania
city: Johnstown
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Reading
country: United States
state: Pennsylvania
city: Anderson
country: United States
state: South Carolina
city: Charleston
country: United States
state: South Carolina
city: Columbia
country: United States
state: South Carolina
city: Greenville
country: United States
state: South Carolina
city: Rock Hill
country: United States
state: South Carolina
city: Simpsonville
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Lake Jackson
country: United States
state: Texas
city: North Richland Hills
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Sugar Land
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Arlington
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: