Study Utilizing Rilonacept in Gout Exacerbations (SURGE)

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Gout Flare
• Intervention / Treatment: Drug: Indomethacin; Other: Placebo (for Rilonacept); Drug: Rilonacept; Other: Placebo (for Indomethacin)

• Study Type: Interventional
• Enrollment (Actual): 225
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States
    • Huntsville, Alabama, United States
  • Arizona
    • Mesa, Arizona, United States
    • Phoenix, Arizona, United States
    • Sierra Vista, Arizona, United States
  • California
    • Burbank, California, United States
    • Whittier, California, United States
  • Florida
    • Clearwater, Florida, United States
    • Debary, Florida, United States
    • Deland, Florida, United States
    • Jupiter, Florida, United States
    • Orange Park, Florida, United States
    • Orlando, Florida, United States
    • Oviedo, Florida, United States
  • Idaho
    • Boise, Idaho, United States
  • Kentucky
    • Elizabethtown, Kentucky, United States
  • Maryland
    • Baltimore, Maryland, United States
    • Wheaton, Maryland, United States
  • Michigan
    • Detroit, Michigan, United States, 48221
    • Stevenville, Michigan, United States
  • Montana
    • Billings, Montana, United States
  • New Mexico
    • Albuquerque, New Mexico, United States
  • New York
    • Albany, New York, United States
  • North Carolina
    • Burlington, North Carolina, United States
    • Cary, North Carolina, United States
    • Raleigh, North Carolina, United States
    • Raleigh, North Carolina, United States, 27612
    • Wilmington, North Carolina, United States
  • Ohio
    • Willoughby Hills, Ohio, United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
  • Oregon
    • Lake Oswego, Oregon, United States
    • Portland, Oregon, United States
  • Pennsylvania
    • Johnstown, Pennsylvania, United States
    • Limerick, Pennsylvania, United States
    • Norristown, Pennsylvania, United States
  • South Carolina
    • Greenville, South Carolina, United States
  • Tennessee
    • Bristol, Tennessee, United States
  • Texas
    • Dallas, Texas, United States
    • Forth Worth, Texas, United States
    • Houston, Texas, United States
    • Irving, Texas, United States
    • Mesquite, Texas, United States
    • North Richland Hills, Texas, United States
    • San Antonio, Texas, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Placebo (for Rilonacept) and Indomethacin; 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).	Drug: Indomethacin; Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).; Other: Placebo (for Rilonacept); Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 (Baseline).
Active Comparator: Rilonacept and Indomethacin; 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).	Drug: Indomethacin; Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).; Drug: Rilonacept; Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 (Baseline).
Active Comparator: Rilonacept and Placebo (for Indomethacin); 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.	Drug: Rilonacept; Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 (Baseline).; Other: Placebo (for Indomethacin); Placebo (for Indomethacin) orally TID for 12 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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 Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (Day 1) to 72 hours
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.	Baseline (Day 1) to 48 hours
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.	Baseline (Day 1) to 24 hours

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals

Publications and helpful links

General Publications

• 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.

Helpful Links

• Rilonacept
• Related Info

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: February 13, 2009
• First Submitted That Met QC Criteria: March 3, 2009
• First Posted (Estimate): March 5, 2009

Study Record Updates

• Last Update Posted (Actual): April 28, 2017
• Last Update Submitted That Met QC Criteria: March 20, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Gout; Allopurinol; Genetic Diseases, Inborn; Metabolic Diseases; Metabolism, Inborn Errors; Flare; Metabolic disorder; Purine-Pyrimidine Metabolism, Inborn Errors
• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Gout; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Reproductive Control Agents; Gout Suppressants; Tocolytic Agents; Indomethacin; Rilonacept
• Other Study ID Numbers: IL1T-GA-0814