Study of the Safety and Effectiveness of Rilonacept for the Prevention of Gout Flares
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
1 other identifier
interventional
83
1 country
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2007
Shorter than P25 for phase_2
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 24, 2008
CompletedFirst Posted
Study publicly available on registry
February 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedResults Posted
Study results publicly available
May 2, 2017
CompletedMay 2, 2017
March 1, 2017
11 months
January 24, 2008
March 20, 2017
March 20, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Gout Flares Per Participant Assessed From Day 1 to Day 84 (Week 12)
A gout flare was defined as participant reported acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Number of gout flares per participant was reported for this outcome measure. For drop-outs, only flares occurred before Day 84 were counted, regardless whether the flares occurred during the treatment period or not.
Day 1 (Baseline) to Day 84 (Week 12)
Secondary Outcomes (6)
Percentage of Participants With at Least One Gout Flare From Day 1 to Day 84 (Week 12)
Day 1 (Baseline) to Day 84 (Week 12)
Mean Number of Gout Flares Per Month Per Participant From Day 1 to Day 84 (Week 12)
Day 1 (Baseline) to Day 84 (Week 12)
Mean Number of Gout Flare Days Per Participant From Day 1 to Day 84 (Week 12)
Day 1 (Baseline) to Day 84 (Week 12)
Mean Number of Gout Flare Days Per Month Per Participant From Day 1 to Day 84 (Week 12)
Day 1 (Baseline) to Day 84 (Week 12)
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)
Day 1 (Baseline) to Day 84 (Week 12)
- +1 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORTwo subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 16.
Rilonacept 160 mg
EXPERIMENTALTwo subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
Interventions
Rilonacept 320 mg loading dose on Day 1 followed by Rilonacept 160 mg/2 mL injections qw for 17 weeks.
Placebo loading dose on Day 1 followed by single placebo injections (2 mL) qw for 17 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Unknown Facility
San Diego, California, 92108, United States
Unknown Facility
Santa Maria, California, 93454, United States
Unknown Facility
Whittier, California, 90601, United States
Unknown Facility
Colorado Srings, Colorado, 80910, United States
Unknown Facility
DeLand, Florida, 32720, United States
Unknown Facility
Ocala, Florida, 34471, United States
Unknown Facility
Orlando, Florida, 32804, United States
Unknown Facility
St. Petersburg, Florida, 33710, United States
Unknown Facility
Tampa, Florida, 33614, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Dunwoody, Georgia, 30338, United States
Unknown Facility
Honolulu, Hawaii, 96814, United States
Unknown Facility
Boise, Idaho, 83702, United States
Unknown Facility
Indianapolis, Indiana, 46268, United States
Unknown Facility
South Bend, Indiana, 46601, United States
Unknown Facility
Owensboro, Kentucky, 42303, United States
Unknown Facility
Wheaton, Maryland, 20902, United States
Unknown Facility
Billings, Montana, 59101, United States
Unknown Facility
Omaha, Nebraska, 68114, United States
Unknown Facility
Reno, Nevada, 89502, United States
Unknown Facility
Albany, New York, 12206, United States
Unknown Facility
Plainview, New York, 11803, United States
Unknown Facility
Roslyn, New York, 11576, United States
Unknown Facility
Monroe, North Carolina, 28112, United States
Unknown Facility
Raleigh, North Carolina, 27612, United States
Unknown Facility
Cincinnati, Ohio, 45242, United States
Unknown Facility
Mayfield Village, Ohio, 44143, United States
Unknown Facility
Oklahoma City, Oklahoma, 73112, United States
Unknown Facility
Duncansville, Pennsylvania, 16635, United States
Unknown Facility
West Reading, Pennsylvania, 19611, United States
Unknown Facility
Charleston, South Carolina, 29406, United States
Unknown Facility
Grenville, South Carolina, 29601, United States
Unknown Facility
Dallas, Texas, 75235, United States
Unknown Facility
Spokane, Washington, 99204, United States
Related Publications (2)
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.
PMID: 22223180DERIVEDKhanna 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.
PMID: 21372003DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Management
- Organization
- Regeneron Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Shirletta King-Davis
Regeneron Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2008
First Posted
February 7, 2008
Study Start
November 1, 2007
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
May 2, 2017
Results First Posted
May 2, 2017
Record last verified: 2017-03