PREventative Study Against URate-lowering Drug-induced Gout Exacerbations 1 (PRE-SURGE1)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Regeneron Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00829829

First received: January 23, 2009

Last updated: April 26, 2012

Last verified: April 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 23, 2009
Last Updated Date	April 26, 2012
Start Date ^ICMJE	February 2009
Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 26, 2009)	number of flares during the treatment period [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00829829 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 20, 2009)	number of modified gout flares per subject from Day 1 to Week 16 [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ] proportion of subjects with at least one flare from Day 1 to Week 16 [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ] proportion of subjects with at least two flares from Day 1 to Week 16 [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ] mean number of gout flare days per subject assessed from Day 1 to Week 16 [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ] mean number of days with the subject's pain score of 5 or more (daily diary) per subject from Day 1 to Week 16 [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE (submitted: January 26, 2009)	number of modified gout flares per subject from Day 1 to Week 16 (a gout flare for this analysis will be defined as subject reported articular pain typical of a gout attack that is deemed to require treatment with an anti-inflammatory agent) [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ] proportion of subjects with at least one flare from Day 1 to Week 16 [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ] proportion of subjects with at least two flares from Day 1 to Week 16 [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ] mean number of gout flare days per subject assessed from Day 1 to Week 16 [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ] mean number of days with the subject's pain score of 5 or more (daily diary) per subject from Day 1 to Week 16 [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	PREventative Study Against URate-lowering Drug-induced Gout Exacerbations 1
Official Title ^ICMJE	A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Rilonacept for the Prophylaxis of Gout Flares During the Initiation of Allopurinol Therapy
Brief Summary	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 beginning allopurinol treatment for gout. Subjects will participate in this study for approximately 22 weeks. Rilonacept is being studied for use in preventing allopurinol-induced gout flares.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Intercritical Gout
Intervention ^ICMJE	Drug: rilonacept Placebo loading dose followed by placebo SC injections (2 mL) once a week for 16 weeks Drug: rilonacept rilonacept 160 mg SC loading dose followed by rilonacept 80 mg/2 mL SC injections once a week for 16 weeks Drug: rilonacept rilonacept 320 mg SC loading dose followed by rilonacept 160 mg/2 mL SC injections once a week for 16 weeks
Study Arm (s)	Placebo Comparator: 1 Placebo Intervention: Drug: rilonacept Active Comparator: 2 rilonacept 80 mg Intervention: Drug: rilonacept Active Comparator: 3 rilonacept 160 mg Intervention: Drug: rilonacept
Publications *	Schumacher HR Jr, Evans RR, Saag KG, Clower J, Jennings W, Weinstein SP, Yancopoulos GD, Wang J, Terkeltaub R. Rilonacept (interleukin-1 trap) for prevention of gout flares during initiation of uric acid-lowering therapy: results from a phase III randomized, double-blind, placebo-controlled, confirmatory efficacy study. Arthritis Care Res (Hoboken). 2012 Oct;64(10):1462-70. doi: 10.1002/acr.21690.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	241
Completion Date	June 2010
Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Male or female 18 to 80 years of age Previously met the preliminary criteria of the ARA for the classification of the acute arthritis of primary gout At least 2 gout flares in the year prior to the Screening Visit Serum uric acid greater than or equal to 7.5 mg/dL at the Screening Visit Exclusion Criteria: Acute gout flare within 2 weeks of the Screening Visit or during Screening Persistent chronic or active infections History of an allergic reaction to allopurinol History or presence of cancer within 5 years of the Screening Visit Previous exposure to rilonacept Use of allopurinol, benzbromarone, febuxostat, probenecid or sulfinpyrazone within 3 months prior to the Screening Visit
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada

Administrative Information
NCT Number ^ICMJE	NCT00829829
Other Study ID Numbers ^ICMJE	IL1T-GA-0810
Has Data Monitoring Committee	Not Provided
Responsible Party	Regeneron Pharmaceuticals
Study Sponsor ^ICMJE	Regeneron Pharmaceuticals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Regeneron Pharmaceuticals
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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