Study of the Safety and Effectiveness of Rilonacept for the Prevention of Gout Flares

Gout Clinical Trial

Official title:

A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study, Tolerability, and Efficacy of Rilonacept for the Prevention of Gout Flares During Initiation of Allopurinol Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00610363
• Other study ID #: IL1T-GA-0619
• Status: Completed
• Phase: Phase 2
• First received: January 24, 2008
• Last updated: September 27, 2013
• Start date: November 2007
• Est. completion date: October 2008

Study information

• Verified date: June 2011
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a clinical research study to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are beginning another additional treatment. Subjects will participate in this study for approximately 24 weeks. Rilonacept is being studied for use in preventing gout attacks in patients who have gout.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female greater than 18 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

Exclusion Criteria:

• Acute gout flare within 2 weeks of the Screening visit and 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

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

Biological:
• rilonacept
160mg sc once a week

Other:
• placebo
placebo sc once a week

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of flares during the treatment period		16 weeks	Yes