Study Utilizing Rilonacept in Gout Exacerbations (SURGE)

• ClinicalTrials.gov Identifier: NCT00855920
• Recruitment Status: Completed
• First Posted: March 5, 2009
• Results First Posted: April 28, 2017
• Last Update Posted: April 28, 2017
• Sponsor: Regeneron Pharmaceuticals
• Information provided by (Responsible Party): Regeneron Pharmaceuticals

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.

Condition or disease	Intervention/treatment	Phase
Acute Gout Flare	Drug: Rilonacept; Drug: Indomethacin; Other: Placebo (for Indomethacin); Other: Placebo (for Rilonacept)	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 225 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: March 2009
• Actual Primary Completion Date: February 2010
• Actual Study Completion Date: February 2010

Arms and Interventions

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: Rilonacept; Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 (Baseline).; Drug: Indomethacin; Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
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.

Outcome Measures

Primary Outcome Measures :

1. 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 [ 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 ]
   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 :

1. Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 72 Hours [ Time Frame: Baseline (Day 1) to 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.
2. Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 48 Hours [ Time Frame: Baseline (Day 1) to 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.
3. Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 24 Hours [ Time Frame: Baseline (Day 1) to 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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 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

Contacts and Locations

Locations

United States, Alabama

Birmingham, Alabama, United States

Huntsville, Alabama, United States

United States, Arizona

Mesa, Arizona, United States

Phoenix, Arizona, United States

Sierra Vista, Arizona, United States

United States, California

Burbank, California, United States

Whittier, California, United States

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

United States, Idaho

Boise, Idaho, United States

United States, Kentucky

Elizabethtown, Kentucky, United States

United States, Maryland

Baltimore, Maryland, United States

Wheaton, Maryland, United States

United States, Michigan

Detroit, Michigan, United States, 48221

Stevenville, Michigan, United States

United States, Montana

Billings, Montana, United States

United States, New Mexico

Albuquerque, New Mexico, United States

United States, New York

Albany, New York, United States

United States, North Carolina

Burlington, North Carolina, United States

Cary, North Carolina, United States

Raleigh, North Carolina, United States, 27612

Raleigh, North Carolina, United States

Wilmington, North Carolina, United States

United States, Ohio

Willoughby Hills, Ohio, United States

United States, Oklahoma

Oklahoma City, Oklahoma, United States

United States, Oregon

Lake Oswego, Oregon, United States

Portland, Oregon, United States

United States, Pennsylvania

Johnstown, Pennsylvania, United States

Limerick, Pennsylvania, United States

Norristown, Pennsylvania, United States

United States, South Carolina

Greenville, South Carolina, United States

United States, Tennessee

Bristol, Tennessee, United States

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

Sponsors and Collaborators

Regeneron Pharmaceuticals

Investigators

• Study Director: Robert Evans, PharmD; Regeneron Pharmaceuticals

More Information

Additional Information:

Rilonacept 

Related Info 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Regeneron Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00855920
• Other Study ID Numbers: IL1T-GA-0814
• First Posted: March 5, 2009
• Results First Posted: April 28, 2017
• Last Update Posted: April 28, 2017
• Last Verified: March 2017

Keywords provided by Regeneron Pharmaceuticals:

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

Additional relevant MeSH terms:

Gout; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Indomethacin; Rilonacept; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Gout Suppressants; Tocolytic Agents; Reproductive Control Agents; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action