Clinical trial NCT00610363: Study of the Safety and Effectiveness of Rilonacept for the Prevention of Gout Flares
Official title: A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study, Tolerability, and Efficacy of Rilonacept for the Prevention of Gout Flares During Initiation of Allopurinol Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gout
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-02-07
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was a clinical research study to determine the safety and effectiveness of an experimental drug called rilonacept in participants with gout who were beginning another additional treatment. Participants participated in this study for approximately 24 weeks. Rilonacept was being studied for use in preventing gout attacks in participants who had gout.


Eligibility criteria: Inclusion Criteria:

* Male or female greater than 18 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.

Exclusion Criteria:

* Acute gout flare within 2 weeks of the screening visit and 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.

Primary outcomes:
measure: Number of Gout Flares Per Participant Assessed From Day 1 to Day 84 (Week 12)
timeFrame: Day 1 (Baseline) to Day 84 (Week 12)
Secondary outcomes:
measure: Percentage of Participants With at Least One Gout Flare From Day 1 to Day 84 (Week 12)
timeFrame: Day 1 (Baseline) to Day 84 (Week 12)
measure: Mean Number of Gout Flares Per Month Per Participant From Day 1 to Day 84 (Week 12)
timeFrame: Day 1 (Baseline) to Day 84 (Week 12)
measure: Mean Number of Gout Flare Days Per Participant From Day 1 to Day 84 (Week 12)
timeFrame: Day 1 (Baseline) to Day 84 (Week 12)
measure: Mean Number of Gout Flare Days Per Month Per Participant From Day 1 to Day 84 (Week 12)
timeFrame: Day 1 (Baseline) to Day 84 (Week 12)
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 84 (Week 12)
timeFrame: Day 1 (Baseline) to Day 84 (Week 12)
measure: Number of Gout Flare Days With Participant's Pain Score of 5 or More (From Daily Diary) Per Month Per Participant From Day 1 to Day 84 (Week 12)
timeFrame: Day 1 (Baseline) to Day 84 (Week 12)
Other outcomes:
Locations:
city: San Diego
country: United States
state: California
city: Santa Maria
country: United States
state: California
city: Whittier
country: United States
state: California
city: Colorado Srings
country: United States
state: Colorado
city: DeLand
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Dunwoody
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Boise
country: United States
state: Idaho
city: Indianapolis
country: United States
state: Indiana
city: South Bend
country: United States
state: Indiana
city: Owensboro
country: United States
state: Kentucky
city: Wheaton
country: United States
state: Maryland
city: Billings
country: United States
state: Montana
city: Omaha
country: United States
state: Nebraska
city: Reno
country: United States
state: Nevada
city: Albany
country: United States
state: New York
city: Plainview
country: United States
state: New York
city: Roslyn
country: United States
state: New York
city: Monroe
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Mayfield Village
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Duncansville
country: United States
state: Pennsylvania
city: West Reading
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Grenville
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: Spokane
country: United States
state: Washington
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Shirletta King-Davis
role: STUDY_DIRECTOR
References:
citation: Schumacher HR Jr, Sundy JS, Terkeltaub R, Knapp HR, Mellis SJ, Stahl N, Yancopoulos GD, Soo Y, King-Davis S, Weinstein SP, Radin AR; 0619 Study Group. Rilonacept (interleukin-1 trap) in the prevention of acute gout flares during initiation of urate-lowering therapy: results of a phase II randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2012 Mar;64(3):876-84. doi: 10.1002/art.33412.
citation: Khanna D, Sarkin AJ, Khanna PP, Shieh MM, Kavanaugh AF, Terkeltaub RA, Lee SJ, Singh JA, Hirsch JD. Minimally important differences of the gout impact scale in a randomized controlled trial. Rheumatology (Oxford). 2011 Jul;50(7):1331-6. doi: 10.1093/rheumatology/ker023. Epub 2011 Mar 3.