Study Utilizing Rilonacept in Gout Exacerbations (SURGE)

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Acute Gout Flare

Treatments: Other: Placebo (for Rilonacept); Other: Placebo (for Indomethacin); Drug: Rilonacept; Drug: Indomethacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00855920

IL1T-GA-0814

Details and patient eligibility

About

This purpose of this clinical research was to determine the efficacy and safety of an experimental drug called Rilonacept in participants with an acute gout attack. Participants participated in this study for 30 days. Rilonacept alone was being compared with Indomethacin alone and the combination of Rilonacept plus Indomethacin in treating acute gout flares.

Enrollment: 225 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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 non-steroidal anti-inflammatory drug (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. Participants with history of chronic, gouty arthritis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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225 participants in 3 patient groups

Placebo (for Rilonacept) and Indomethacin

Active Comparator group

Description:

Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally thrice a day (TID) for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).

Treatment:

Drug: Indomethacin

Other: Placebo (for Rilonacept)

Rilonacept and Indomethacin

Active Comparator group

Description:

Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).

Treatment:

Drug: Indomethacin

Drug: Rilonacept

Rilonacept and Placebo (for Indomethacin)

Active Comparator group

Description:

Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.

Treatment:

Other: Placebo (for Indomethacin)

Drug: Rilonacept