Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares

Gout Clinical Trial

— UPSURGE  

Official title:

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01459796
• Other study ID #: IL1T-GA-1101
• Status: Terminated
• Phase: Phase 3
• First received: October 12, 2011
• Last updated: September 27, 2013
• Start date: November 2011
• Est. completion date: June 2013

Study information

• Verified date: November 2012
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and tolerability of rilonacept for patients with gout who are initiating allopurinol.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 219
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

Key Inclusion criteria:

• Male or female patients aged 18 to 80 years

• Previously met the preliminary criteria of the ARA for the classification of the acute arthritis of primary gout

• Serum uric acid greater than or equal to 7.5 mg/dL at the Screening Visit

• A self-reported history of at least 2 gout flares in the year prior to screening

Exclusion Criteria:

Key Exclusion criteria:

• Pregnant or nursing, or planning to become pregnant or father a child within 3 months after receiving the last dose of study drug

• Patients requiring dialysis

• Patients who have had an organ transplant

• Persistent chronic or active infections

• Previous exposure to rilonacept

• Use of allopurinol, benzbromarone, febuxostat, probenecid or sulfinpyrazone within 84 days prior to the Screening Visit

Study Design

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

Related Conditions & MeSH terms

• Gout

Intervention

Drug:
• Rilonacept
Regimen 1
• Placebo
Regimen 2
• Allopurinol
Background Treatment

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	Summary of TEAEs (Treatment-Emergent Adverse Events)	Safety as assessed by summarizing the incidences and types of treatment-emergent adverse events (TEAEs) and changes in laboratory parameters from day 1 to wk 56	day 1 to week 56	Yes
Secondary	Proportion of patients with 1 or more gout flares from day 1 to week 24		day 1 to week 24	No
Secondary	Proportion of patients with 1 or more gout flares from day 1 to wk 52		day 1 to week 52	No
Secondary	Proportion of patients with 2 or more gout flares from day 1 to wk 52.		day 1 to week 52	No
Secondary	Proportion of patients with 2 or more gout flares from day 1 to week 24		day 1 to week 24	No