Phase 3
Completed N=225
Study Utilizing Rilonacept in Gout Exacerbations
Acute Gout Flare
Source: ClinicalTrials.gov NCT00855920 ↗
Enrolled (actual)
225
Serious AEs
1.3%
Results posted
Apr 2017
Primary outcomePrimary: 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
◆ Published Evidence
Highly cited
122citations · ~9 / year
Rilonacept in the treatment of acute gouty arthritis: a randomized, controlled clinical trial using indomethacin as the active comparator.
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.
Linked Publications
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Rilonacept in the treatment of acute gouty arthritis: a randomized, controlled clinical trial using indomethacin as the active comparator.
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 | — |
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
Data sourced from ClinicalTrials.gov (NCT00855920) and the linked publication. 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. Informational only — not medical advice.