Review of Safety Using Rilonacept in Preventing Gout Exacerbations (RE-SURGE)

This study is currently recruiting participants.

Verified by Regeneron Pharmaceuticals, April 2009

First Received: February 21, 2009 Last Updated: April 9, 2009 History of Changes

Sponsored by:	Regeneron Pharmaceuticals
Information provided by:	Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00856206

Purpose

The purpose of this clinical research study is to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are on urate-lowering therapy. Subjects will participate in this study for approximately 20 weeks. Rilonacept is being studied for use in preventing gout flares in subjects on urate-lowering therapy.

Condition	Intervention	Phase
Gout	Biological: Rilonacept Other: Placebo	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study
Official Title:	A Multi-Center, Randomized, Double-Blind, Placebo Controlled Trial of the Safety of Rilonacept for the Prophylaxis of Gout Flares in Patients on Urate- Lowering Therapy

Resource links provided by NLM:

MedlinePlus related topics: Gout Joint Disorders Metabolic Disorders

Drug Information available for: Rilonacept

U.S. FDA Resources

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:

Safety assessed by summarizing the incidences and types of treatment emergent adverse events and lab parameter changes. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Number of gout flares from Day 1 to Week 16 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	1200
Study Start Date:	March 2009
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Rilonacept 320 mg SC loading dose followed by 160 mg SC weekly for 16 weeks.	Biological: Rilonacept 160mg once a week
2: Placebo Comparator Placebo SC loading dose followed by placebo SC weekly for 16 weeks	Other: Placebo Placebo once a week

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female 18 to 80 years of age
Previously met the preliminary criteria of ARA for the classification of acute gout arthritis of primary gout
Subjects with history of gout, initiating or currently on urate lowering therapy who are at risk of gout flare

Exclusion Criteria:

Acute gout flare within 2 weeks prior to the Screening Visit and during the screening visit
Persistent chronic or active infections
History of an allergic reaction to allopurinol
History or presence of cancer within 5 years of the Screening Visit

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00856206

Contacts

Contact: Kim Parsons	708-386-9616	kimberly.parsons@quintiles.com
Contact: John Mapel	512-416-5003	john.mapel@quintiles.com

Locations

United States, Florida
	Recruiting
Deland, Florida, United States
United States, Georgia
	Recruiting
Canton, Georgia, United States
United States, Kentucky
	Recruiting
Lexington, Kentucky, United States
United States, New Jersey
	Recruiting
Elizabeth, New Jersey, United States
United States, Ohio
	Recruiting
Middleburg Heights, Ohio, United States
United States, Tennessee
	Recruiting
Johnson City, Tennessee, United States
United States, Texas
	Recruiting
Houston, Texas, United States
United States, Virginia
	Recruiting
Norfolk, Virginia, United States

Sponsors and Collaborators

Regeneron Pharmaceuticals

Investigators

Study Director:

Robert Evans, PharmD

Regeneron Pharmaceuticals

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Regeneron Pharmaceuticals, Inc. ( Robert Evans, PharmD/Director of Clinical Sciences )
Study ID Numbers:	IL1T-GA-0815
Study First Received:	February 21, 2009
Last Updated:	April 9, 2009
ClinicalTrials.gov Identifier:	NCT00856206 History of Changes
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; Germany: Paul-Ehrlich-Institut; South Africa: Medicines Control Council; India: Drugs Controller General of India; Indonesia: National Agency of Drug and Food Control; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Regeneron Pharmaceuticals:

Metabolism, Inborn Errors
Allopurinol
Metabolic Disease
Genetic Diseases, Inborn
Musculoskeletal Diseases
Joint Diseases

Arthritis
Rheumatic Diseases
Metabolic disorder
Purine Pyrimidine Metabolism, Inborn Errors
Gout
Intercritical Gout

Study placed in the following topic categories:

Metabolism, Inborn Errors
Uric Acid
Allopurinol
Metabolic Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn

Arthritis
Joint Diseases
Rheumatic Diseases
Metabolic Disorder
Purine-Pyrimidine Metabolism, Inborn Errors
Gout

Additional relevant MeSH terms:

Metabolism, Inborn Errors
Metabolic Diseases
Genetic Diseases, Inborn
Musculoskeletal Diseases
Joint Diseases

Arthritis
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Gout

ClinicalTrials.gov processed this record on September 10, 2009