Back to resultsStudy Utilizing Rilonacept in Gout Exacerbations (SURGE)
Primary Purpose
Acute Gout Flare
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Rilonacept
Indomethacin
Placebo (for Indomethacin)
Placebo (for Rilonacept)
Sponsored by
About this trial
This is an interventional treatment trial for Acute Gout Flare focused on measuring 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
Eligibility Criteria
Inclusion Criteria:
- Male or female 18 - 70 years of age
- Previously met the preliminary criteria of ARA for the classification of the acute arthritis of primary gout
- Presenting with an acute attack (flare) of gout within 48 hours of pain onset and pain of at least moderate severity
- Must have at least 1 on the 0-3 scale for the swelling and the tenderness assessments of the gouty index joint
- Current presentation of acute gout flare in 3 joints or less
Exclusion Criteria:
- 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.
- Treatment with oral analgesics within 6 hours before baseline assessments. Treatment with topical analgesics within 12 hours before baseline assessments
- History of NSAID intolerance
- Participants with history of chronic, gouty arthritis
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Placebo (for Rilonacept) and Indomethacin
Rilonacept and Indomethacin
Rilonacept and Placebo (for Indomethacin)
Arm Description
Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally thrice a day (TID) for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
Outcomes
Primary Outcome Measures
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
Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain. Change in PAP-LS in the index joint from baseline (Day 1) to the averaged PAP-LS values at 24, 48 and 72 hours was reported in this outcome measure (averaged PAP value= [PAP at 24 hours + PAP at 48 hours + PAP at 72 hours]/3).
Secondary Outcome Measures
Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 72 Hours
Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain.
Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 48 Hours
Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain.
Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 24 Hours
Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain.
Full Information
NCT ID
NCT00855920
First Posted
February 13, 2009
Last Updated
March 20, 2017
Sponsor
Regeneron Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00855920
Brief Title
Study Utilizing Rilonacept in Gout Exacerbations
Acronym
SURGE
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
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
225 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo (for Rilonacept) and Indomethacin
Arm Type
Active Comparator
Arm Description
Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally thrice a day (TID) for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
Arm Title
Rilonacept and Indomethacin
Arm Type
Active Comparator
Arm Description
Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
Arm Title
Rilonacept and Placebo (for Indomethacin)
Arm Type
Active Comparator
Arm Description
Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
Intervention Type
Drug
Intervention Name(s)
Rilonacept
Intervention Description
Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 (Baseline).
Intervention Type
Drug
Intervention Name(s)
Indomethacin
Intervention Description
Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
Intervention Type
Other
Intervention Name(s)
Placebo (for Indomethacin)
Intervention Description
Placebo (for Indomethacin) orally TID for 12 days.
Intervention Type
Other
Intervention Name(s)
Placebo (for Rilonacept)
Intervention Description
Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 (Baseline).
Primary Outcome Measure Information:
Title
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
Description
Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain. Change in PAP-LS in the index joint from baseline (Day 1) to the averaged PAP-LS values at 24, 48 and 72 hours was reported in this outcome measure (averaged PAP value= [PAP at 24 hours + PAP at 48 hours + PAP at 72 hours]/3).
Time Frame
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 Outcome Measure Information:
Title
Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 72 Hours
Description
Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain.
Time Frame
Baseline (Day 1) to 72 hours
Title
Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 48 Hours
Description
Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain.
Time Frame
Baseline (Day 1) to 48 hours
Title
Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 24 Hours
Description
Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain.
Time Frame
Baseline (Day 1) to 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female 18 - 70 years of age
Previously met the preliminary criteria of ARA for the classification of the acute arthritis of primary gout
Presenting with an acute attack (flare) of gout within 48 hours of pain onset and pain of at least moderate severity
Must have at least 1 on the 0-3 scale for the swelling and the tenderness assessments of the gouty index joint
Current presentation of acute gout flare in 3 joints or less
Exclusion Criteria:
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.
Treatment with oral analgesics within 6 hours before baseline assessments. Treatment with topical analgesics within 12 hours before baseline assessments
History of NSAID intolerance
Participants with history of chronic, gouty arthritis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Evans, PharmD
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Huntsville
State/Province
Alabama
Country
United States
City
Mesa
State/Province
Arizona
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
Sierra Vista
State/Province
Arizona
Country
United States
City
Burbank
State/Province
California
Country
United States
City
Whittier
State/Province
California
Country
United States
City
Clearwater
State/Province
Florida
Country
United States
City
Debary
State/Province
Florida
Country
United States
City
Deland
State/Province
Florida
Country
United States
City
Jupiter
State/Province
Florida
Country
United States
City
Orange Park
State/Province
Florida
Country
United States
City
Orlando
State/Province
Florida
Country
United States
City
Oviedo
State/Province
Florida
Country
United States
City
Boise
State/Province
Idaho
Country
United States
City
Elizabethtown
State/Province
Kentucky
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Wheaton
State/Province
Maryland
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48221
Country
United States
City
Stevenville
State/Province
Michigan
Country
United States
City
Billings
State/Province
Montana
Country
United States
City
Albuquerque
State/Province
New Mexico
Country
United States
City
Albany
State/Province
New York
Country
United States
City
Burlington
State/Province
North Carolina
Country
United States
City
Cary
State/Province
North Carolina
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
City
Raleigh
State/Province
North Carolina
Country
United States
City
Wilmington
State/Province
North Carolina
Country
United States
City
Willoughby Hills
State/Province
Ohio
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Lake Oswego
State/Province
Oregon
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Johnstown
State/Province
Pennsylvania
Country
United States
City
Limerick
State/Province
Pennsylvania
Country
United States
City
Norristown
State/Province
Pennsylvania
Country
United States
City
Greenville
State/Province
South Carolina
Country
United States
City
Bristol
State/Province
Tennessee
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Forth Worth
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Irving
State/Province
Texas
Country
United States
City
Mesquite
State/Province
Texas
Country
United States
City
North Richland Hills
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23375025
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.
Results Reference
derived
Links:
URL
http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?mergeData=true&objectHandle=DBMaint&APPLICATION_NAME=drugportal&actionHandle=default&nextPage=jsp/drugportal/ResultScreen.jsp&TXTSUPERLISTID=501081761&QV1=RILONACEPT
Description
Rilonacept
URL
http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?objectHandle=DBMaint&APPLICATION_NAME=drugportal&mergeData=true&actionHandle=default&nextPage=jsp%2Fdrugportal%2FResultScreen.jsp%3FprevPage%3Djsp%2Fdrugportal%2FChemidDataview.jsp%26OriginalSearc
Description
Related Info
Learn more about this trial
Study Utilizing Rilonacept in Gout Exacerbations
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