PREventative Study Against URate-Lowering Drug-Induced Gout Exacerbations (PRE-SURGE 2)

Gout Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00958438
• Other study ID #: IL1T-GA-0816
• Secondary ID: 2008-007762-39
• Status: Completed
• Phase: Phase 3
• First received: August 11, 2009
• Last updated: December 1, 2011
• Start date: July 2009
• Est. completion date: December 2010

Study information

• Verified date: December 2011
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSouth Africa: Medicines Control CouncilGermany: Paul-Ehrlich-InstitutIndia: Drugs Controller General of IndiaIndonesia: National Agency of Drug and Food ControlTaiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gout

Intervention

Drug:
• placebo
Placebo loading dose followed by placebo SC injections (2 mL) once a week for 16 weeks
• rilonacept
rilonacept 160 mg SC loading dose followed by rilonacept 80 mg/2 mL SC injections once a week for 16 weeks
• rilonacept
rilonacept 320 mg SC loading dose followed by rilonacept 160 mg/2 mL SC injections once a week for 16 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Countries where clinical trial is conducted

Germany,  India,  Indonesia,  South Africa,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of flares during the treatment period		16 Weeks	Yes
Secondary	number of modified gout flares per subject from Day 1 to Week 16		16 Weeks	Yes
Secondary	proportion of subjects with at least one flare from Day 1 to Week 16		16 Weeks	Yes
Secondary	proportion of subjects with at least two flares from Day 1 to Week 16		16 Weeks	Yes
Secondary	mean number of gout flare days per subject assessed from Day 1 to Week 16		16 Weeks	Yes
Secondary	mean number of days with the subject's pain score of 5 or more (daily diary) per subject from Day 1 to Week 16		16 Weeks	Yes

External Links

•   Allopurinol
•   Allopurinol sodium
•   Rilonacept