Phase 3
Completed N=1,315
Review of Safety Using Rilonacept in Preventing Gout Exacerbations (RE-SURGE)
Source: ClinicalTrials.gov NCT00856206 ↗Enrolled (actual)
1,315
Serious AEs
3.4%
Results posted
Apr 2017
Primary outcomePrimary: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) — 59.1; 66.6; 13.0; 27.5 percentage of participants
◆ Published Evidence
Established
72citations · ~6 / year
Rilonacept for gout flare prevention in patients receiving uric acid-lowering therapy: results of RESURGE, a phase III, international safety study.
Summary
The purpose of this clinical research study is to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are on urate-lowering therapy. Subjects will participate in this study for approximately 20 weeks. Rilonacept is being studied for use in preventing gout flares in subjects on urate-lowering therapy.
Linked Publications
-
Rilonacept for gout flare prevention in patients receiving uric acid-lowering therapy: results of RESURGE, a phase III, international safety study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) |
59.1; 66.6; 13.0; 27.5; 3.9; 3.1 | — |
| SECONDARY Number of Gout Flares Per Participant Assessed From Day 1 to Day 112 (Week 16) |
1.73; 0.51 | — |
| SECONDARY Percentage of Participants With at Least One Flare From Day 1 to Day 112 (Week 16) |
51.1; 25.7 | — |
| SECONDARY Percentage of Participants With at Least Two Flares From Day 1 to Day 112 (Week 16) |
34.7; 11.7 | — |
| SECONDARY Number of Gout Flare Days Per Participant From Day 1 to Day 112 (Week 16) |
7.66; 2.66 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female 18 to 80 years of age;
- Previously met the preliminary criteria of American Rheumatism Associatio (ARA) for the classification of acute gout arthritis of primary gout;
- Subjects with history of gout, initiating or currently on urate lowering; therapy who are at risk of gout flare.
Exclusion Criteria
- Acute gout flare within 2 weeks prior to the screening visit and during the screening visit;
- Persistent chronic or active infections;
- History of an allergic reaction to allopurinol;
- History or presence of cancer within 5 years of the Screening Visit;;;
Data sourced from ClinicalTrials.gov (NCT00856206) 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.