Phase 3 N=225 Randomized Quadruple-blind Treatment

Study Utilizing Rilonacept in Gout Exacerbations

Acute Gout Flare

Bottom Line

View on ClinicalTrials.gov: NCT00855920 ↗

Enrolled (actual)

225

Serious AEs

1.3%

Results posted

Apr 2017

Primary outcome: Primary: Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint to Averaged PAP-LS at 24, 48 and 72 Hours — -1.40; -1.55; -0.69 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Rilonacept (Drug); Indomethacin (Drug); Placebo (for Indomethacin) (Other); Placebo (for Rilonacept) (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Regeneron Pharmaceuticals
Primary completion: Feb 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint to Averaged PAP-LS at 24, 48 and 72 Hours	-1.40; -1.55; -0.69	—
SECONDARY Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 72 Hours	-1.41; -1.57; -1.29	—
SECONDARY Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 48 Hours	-1.36; -1.54; -1.08	—
SECONDARY Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 24 Hours	-1.16; -1.44; -0.55	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

Male or female 18 - 70 years of age
Previously met the preliminary criteria of ARA for the classification of the acute arthritis of primary gout
Presenting with an acute attack (flare) of gout within 48 hours of pain onset and pain of at least moderate severity
Must have at least 1 on the 0-3 scale for the swelling and the tenderness assessments of the gouty index joint
Current presentation of acute gout flare in 3 joints or less

Exclusion Criteria

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.
Treatment with oral analgesics within 6 hours before baseline assessments. Treatment with topical analgesics within 12 hours before baseline assessments
History of NSAID intolerance
Participants with history of chronic, gouty arthritis

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00855920). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.