Study Utilizing Rilonacept in Gout Exacerbations

Acute Gout Flare Clinical Trial

— SURGE  

Official title:

A Multi-Center, Randomized, Double-Blind, Active-Controlled Study of the Safety and Efficacy of Rilonacept Administered Subcutaneously for the Treatment of an Acute Gout Flare

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00855920
• Other study ID #: IL1T-GA-0814
• Status: Completed
• Phase: Phase 3
• First received: February 13, 2009
• Last updated: September 27, 2013
• Start date: March 2009
• Est. completion date: February 2010

Study information

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

Clinical Trial Summary

This purpose of this clinical research is to determine the efficacy and safety of an experimental drug called rilonacept in subjects with an acute gout attack. Subjects will participate in in this study for 30 days. Rilonacept alone is being compared with indomethacin alone and the combination of rilonacept plus indomethacin in treating acute gout flares.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Male or female 18 - 70 years of age

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

3. Presenting with an acute attack (flare) of gout within 48 hours of pain onset and pain of at least moderate severity

4. Must have at least 1 on the 0-3 scale for the swelling and the tenderness assessments of the gouty index joint

5. Current presentation of acute gout flare in 3 joints or less

Exclusion Criteria:

1. Treatment with any NSAIDs or opiates within 48 hours prior to baseline assessments. Treatment with long-acting NSAIDs within 1 month prior to baseline visit. Treatment with naproxen, meloxicam, nabumetone, celecoxib and indomethacin SR within 5 days prior to baseline visit.

2. Treatment with oral analgesics within 6 hours before baseline assessments. Treatment with topical analgesics within 12 hours before baseline assessments

3. History of NSAID intolerance

4. Subjects with history of chronic, gouty arthritis

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

• Acute Gout Flare
• Gout

Intervention

Drug:
• rilonacept
rilonacept 320 mg SC injection at baseline
• indomethacin
oral indomethacin for 12 days (50mg TID for 3 days, then 25mg TID x 9 days)

Other:
• placebo
oral placebo TID x 12 days
• placebo
placebo one time dose

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	The change in PAP (patient's assessment of pain) in the index joint from baseline measured over 72 hours		72 hours	Yes
Secondary	The change from baseline in PAP at Days 2, 3 and 4		4 days	Yes

External Links

•   Link
•   Rilonacept