Clinical trial NCT00855920: Study Utilizing Rilonacept in Gout Exacerbations
Official title: A Multi-Center, Randomized, Double-Blind, Active-Controlled Study of the Safety and Efficacy of Rilonacept Administered Subcutaneously for the Treatment of an Acute Gout Flare
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Gout Flare
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
Flare
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-03-05
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This purpose of this clinical research was to determine the efficacy and safety of an experimental drug called Rilonacept in participants with an acute gout attack. Participants participated in this study for 30 days. Rilonacept alone was being compared with Indomethacin alone and the combination of Rilonacept plus Indomethacin in treating acute gout flares.


Eligibility criteria: Inclusion Criteria:

1. Male or female 18 - 70 years of age
2. Previously met the preliminary criteria of ARA for the classification of the acute arthritis of primary gout
3. Presenting with an acute attack (flare) of gout within 48 hours of pain onset and pain of at least moderate severity
4. Must have at least 1 on the 0-3 scale for the swelling and the tenderness assessments of the gouty index joint
5. Current presentation of acute gout flare in 3 joints or less

Exclusion Criteria:

1. Treatment with any non-steroidal anti-inflammatory drug (NSAIDs) or opiates within 48 hours prior to baseline assessments. Treatment with long-acting NSAIDs within 1 month prior to baseline visit. Treatment with naproxen, meloxicam, nabumetone, celecoxib and indomethacin SR within 5 days prior to baseline visit.
2. Treatment with oral analgesics within 6 hours before baseline assessments. Treatment with topical analgesics within 12 hours before baseline assessments
3. History of NSAID intolerance
4. Participants with history of chronic, gouty arthritis

Primary outcomes:
measure: Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint to Averaged PAP-LS at 24, 48 and 72 Hours
timeFrame: Pre-dose on Day 1 (Baseline); post-dose at 4, 8, 12, 24, 48, 72 hours and then daily up to Day 13 or until gout flare ends
Secondary outcomes:
measure: Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 72 Hours
timeFrame: Baseline (Day 1) to 72 hours
measure: Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 48 Hours
timeFrame: Baseline (Day 1) to 48 hours
measure: Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 24 Hours
timeFrame: Baseline (Day 1) to 24 hours
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Mesa
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Sierra Vista
country: United States
state: Arizona
city: Burbank
country: United States
state: California
city: Whittier
country: United States
state: California
city: Clearwater
country: United States
state: Florida
city: Debary
country: United States
state: Florida
city: Deland
country: United States
state: Florida
city: Jupiter
country: United States
state: Florida
city: Orange Park
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Oviedo
country: United States
state: Florida
city: Boise
country: United States
state: Idaho
city: Elizabethtown
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Wheaton
country: United States
state: Maryland
city: Detroit
country: United States
state: Michigan
city: Stevenville
country: United States
state: Michigan
city: Billings
country: United States
state: Montana
city: Albuquerque
country: United States
state: New Mexico
city: Albany
country: United States
state: New York
city: Burlington
country: United States
state: North Carolina
city: Cary
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Willoughby Hills
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Lake Oswego
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Johnstown
country: United States
state: Pennsylvania
city: Limerick
country: United States
state: Pennsylvania
city: Norristown
country: United States
state: Pennsylvania
city: Greenville
country: United States
state: South Carolina
city: Bristol
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Forth Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Irving
country: United States
state: Texas
city: Mesquite
country: United States
state: Texas
city: North Richland Hills
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Robert Evans, PharmD
role: STUDY_DIRECTOR
References:
citation: Terkeltaub RA, Schumacher HR, Carter JD, Baraf HS, Evans RR, Wang J, King-Davis S, Weinstein SP. Rilonacept in the treatment of acute gouty arthritis: a randomized, controlled clinical trial using indomethacin as the active comparator. Arthritis Res Ther. 2013 Feb 1;15(1):R25. doi: 10.1186/ar4159.