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

Gout Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00856206
• Other study ID #: IL1T-GA-0815
• Status: Completed
• Phase: Phase 3
• First received: February 21, 2009
• Last updated: December 1, 2011
• Start date: March 2009
• Est. completion date: January 2011

Study information

• Verified date: December 2011
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesGermany: Paul-Ehrlich-InstitutSouth Africa: Medicines Control CouncilIndia: Drugs Controller General of IndiaIndonesia: National Agency of Drug and Food ControlUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1274
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• 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 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

Study Design

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

Related Conditions & MeSH terms

• Gout

Intervention

Biological:
• Rilonacept
160mg once a week

Other:
• Placebo
Placebo once a week

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Germany,  India,  Indonesia,  South Africa,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessed by summarizing the incidences and types of treatment emergent adverse events and lab parameter changes.		16 weeks	Yes
Secondary	Number of gout flares from Day 1 to Week 16		16 weeks	No