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History of Changes for Study: NCT00855920
Study Utilizing Rilonacept in Gout Exacerbations (SURGE)
Latest version (submitted March 20, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 3, 2009 None (earliest Version on record)
2 March 19, 2009 Recruitment Status, Study Status and Contacts/Locations
3 March 30, 2009 References and Study Status
4 May 19, 2009 Study Status and Contacts/Locations
5 November 19, 2009 Study Status
6 March 24, 2010 Recruitment Status, Study Status and Contacts/Locations
7 January 5, 2011 Study Status
8 June 1, 2011 Study Status, Study Design and Oversight
9 June 23, 2011 Arms and Interventions and Study Status
10 September 27, 2013 Sponsor/Collaborators and Study Status
11 March 20, 2017 Outcome Measures, Study Status, Arms and Interventions, More Information, Reported Adverse Events, Baseline Characteristics, Participant Flow, Eligibility and Study Description
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Study NCT00855920
Submitted Date:  November 19, 2009 (v5)

Open or close this module Study Identification
Unique Protocol ID: IL1T-GA-0814
Brief Title: Study Utilizing Rilonacept in Gout Exacerbations (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
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2009
Overall Status: Recruiting
Study Start: March 2009
Primary Completion: March 2010 [Anticipated]
Study Completion: April 2010 [Anticipated]
First Submitted: February 13, 2009
First Submitted that
Met QC Criteria:
March 3, 2009
First Posted: March 5, 2009 [Estimate]
Last Update Submitted that
Met QC Criteria:
November 19, 2009
Last Update Posted: November 23, 2009 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Regeneron Pharmaceuticals
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: This purpose of this clinical research is to determine the efficacy and safety of an experimental drug called rilonacept in subjects with an acute gout attack. Subjects will participate in in this study for 30 days. Rilonacept alone is being compared with indomethacin alone and the combination of rilonacept plus indomethacin in treating acute gout flares.
Detailed Description:
Open or close this module Conditions
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
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 225 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: 1
placebo and indomethacin
Drug: placebo and indomethacin
Placebo one time dose and oral indomethacin for 12 days (50 mg TID for 3 days, then 25 mg TID x 9 days)
Active Comparator: 2
rilonacept 320 mg and indomethacin
Drug: rilonacept and indomethacin
rilonacept 320 mg SC injection at baseline and oral indomethacin x 12 days (50 mg TID for 3 days, then 25 mg TID x 9 days)
Active Comparator: 3
rilonacept 320 mg and placebo
Drug: rilonacept and placebo
rilonacept 320mg SC injection at baseline and oral placebo TID x 12 days
Open or close this module Outcome Measures
Primary Outcome Measures:
1. The change in PAP (patient's assessment of pain) in the index joint from baseline measured over 72 hours

[Time Frame: 72 hours]
Secondary Outcome Measures:
2. The change from baseline in PAP at Days 2, 3 and 4

[Time Frame: 4 days]
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 70 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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 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. Subjects with history of chronic, gouty arthritis
Open or close this module Contacts/Locations
Central Contact Person: Robert Evans
Telephone: 9143457400 Ext. 7782
Email: robert.evans@regeneron.com
Study Officials: Robert Evans, PharmD
Study Director
Regeneron Pharmaceuticals
Locations: United States, Alabama
[Recruiting]
Birmingham, Alabama, United States
[Recruiting]
Huntsville, Alabama, United States
United States, Arizona
[Recruiting]
Mesa, Arizona, United States
[Recruiting]
Phoenix, Arizona, United States
[Recruiting]
Sierra Vista, Arizona, United States
United States, California
[Recruiting]
Burbank, California, United States
[Recruiting]
Whittier, California, United States
United States, Florida
[Recruiting]
Clearwater, Florida, United States
[Recruiting]
Debary, Florida, United States
[Recruiting]
Deland, Florida, United States
[Recruiting]
Jupiter, Florida, United States
[Recruiting]
Orange Park, Florida, United States
[Recruiting]
Orlando, Florida, United States
[Recruiting]
Oviedo, Florida, United States
United States, Idaho
[Recruiting]
Boise, Idaho, United States
United States, Kentucky
[Recruiting]
Elizabethtown, Kentucky, United States
United States, Maryland
[Recruiting]
Baltimore, Maryland, United States
[Recruiting]
Wheaton, Maryland, United States
United States, Michigan
[Recruiting]
Detroit, Michigan, United States, 48221
[Recruiting]
Stevenville, Michigan, United States
United States, Montana
[Recruiting]
Billings, Montana, United States
United States, New Mexico
[Recruiting]
Albuquerque, New Mexico, United States
United States, New York
[Recruiting]
Albany, New York, United States
United States, North Carolina
[Recruiting]
Burlington, North Carolina, United States
[Recruiting]
Cary, North Carolina, United States
[Recruiting]
Raleigh, North Carolina, United States, 27612
[Recruiting]
Raleigh, North Carolina, United States
[Recruiting]
Wilmington, North Carolina, United States
United States, Ohio
[Recruiting]
Willoughby Hills, Ohio, United States
United States, Oklahoma
[Recruiting]
Oklahoma City, Oklahoma, United States
United States, Oregon
[Recruiting]
Lake Oswego, Oregon, United States
[Recruiting]
Portland, Oregon, United States
United States, Pennsylvania
[Recruiting]
Johnstown, Pennsylvania, United States
[Recruiting]
Limerick, Pennsylvania, United States
[Recruiting]
Norristown, Pennsylvania, United States
United States, South Carolina
[Recruiting]
Greenville, South Carolina, United States
United States, Tennessee
[Recruiting]
Bristol, Tennessee, United States
United States, Texas
[Recruiting]
Dallas, Texas, United States
[Recruiting]
Forth Worth, Texas, United States
[Recruiting]
Houston, Texas, United States
[Recruiting]
Irving, Texas, United States
[Recruiting]
Mesquite, Texas, United States
[Recruiting]
North Richland Hills, Texas, United States
[Recruiting]
San Antonio, Texas, United States
Open or close this module IPDSharing
Plan to Share IPD:

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