Expired Study
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Delray Beach, Florida 33446


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 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.


Criteria:

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


Study is Available At:


Original ID:

IL1T-GA-0810


NCT ID:

NCT00829829


Secondary ID:


Study Acronym:

PRE-SURGE1


Brief Title:

PREventative Study Against URate-lowering Drug-induced Gout Exacerbations 1


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Regeneron Pharmaceuticals


Oversight Authority:

  • United States: Food and Drug Administration
  • Canada: Health Canada
  • Canada: Ethics Review Committee


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

241


Enrollment Type:

Actual


Study Dates

Start Date:February 2009
Completion Date:June 2010
Completion Type:Actual
Primary Completion Date:May 2010
Primary Completion Type:Actual
Verification Date:April 2012
Last Changed Date:April 26, 2012
First Received Date:January 23, 2009

Study Outcomes

Outcome Type:Primary Outcome
Measure:number of flares during the treatment period
Time Frame:16 Weeks
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:number of modified gout flares per subject from Day 1 to Week 16
Time Frame:16 Weeks
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:proportion of subjects with at least one flare from Day 1 to Week 16
Time Frame:16 Weeks
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:proportion of subjects with at least two flares from Day 1 to Week 16
Time Frame:16 Weeks
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:mean number of gout flare days per subject assessed from Day 1 to Week 16
Time Frame:16 Weeks
Safety Issues:True
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:rilonacept
Description:Placebo loading dose followed by placebo SC injections (2 mL) once a week for 16 weeks
Arm Name:1
Intervention Type:Drug
Name:rilonacept
Description:rilonacept 160 mg SC loading dose followed by rilonacept 80 mg/2 mL SC injections once a week for 16 weeks
Arm Name:2
Intervention Type:Drug
Name:rilonacept
Description:rilonacept 320 mg SC loading dose followed by rilonacept 160 mg/2 mL SC injections once a week for 16 weeks
Arm Name:3

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:1
Description:Placebo
Study Arm Type:Active Comparator
Arm Name:2
Description:rilonacept 80 mg
Study Arm Type:Active Comparator
Arm Name:3
Description:rilonacept 160 mg

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Regeneron Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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