Trial · NCT00856206
Review of Safety Using Rilonacept in Preventing Gout Exacerbations (RE-SURGE)
NCT00856206, Phase 3, Completed, Regeneron Pharmaceuticals; results first posted 2017-04-28
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Review of Safety Using Rilonacept in Preventing Gout Exacerbations (RE-SURGE). Trials, record NCT00856206. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00856206
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Review of Safety Using Rilonacept in Preventing Gout Exacerbations (RE-SURGE)
- NCT number
- NCT00856206
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,315 participants, actual
- Lead sponsor
- Regeneron Pharmaceuticals
- Conditions
- Gout
- Interventions
- Rilonacept, Placebo
- First posted
- 2009-03-05
- Last updated
- 2017-04-28
- Results first posted
- 2017-04-28
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Baseline up to Week 20 | Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the administration of first dose of study drug up to 35 days after the last dose of study drug). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. |
| Secondary | Number of Gout Flares Per Participant Assessed From Day 1 to Day 112 (Week 16) | Day 1 to Day 112 (Week 16) | A gout flare was defined as participant reported acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Number of gout flares per participant was reported for this outcome measure. For drop-outs, only flares occurred before Day 112 were counted, regardless whether the flares occurred during the treatment period or not. |
| Secondary | Percentage of Participants With at Least One Flare From Day 1 to Day 112 (Week 16) | Day 1 to Day 112 (Week 16) | A gout flare was defined as participant reported acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least one gout flare was reported for this outcome measure. For drop-outs, only flares occurred before Day 112 were counted, regardless whether the flares occurred during the treatment period or not. |
| Secondary | Percentage of Participants With at Least Two Flares From Day 1 to Day 112 (Week 16) | Day 1 to Day 112 (Week 16) | A gout flare was defined as participant reported acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least two gout flare was reported for this outcome measure. For drop-outs, only flares occurred before Day 112 were counted, regardless whether the flares occurred during the treatment period or not. |
| Secondary | Number of Gout Flare Days Per Participant From Day 1 to Day 112 (Week 16) | Day 1 to Day 112 (Week 16) | A gout flare was defined as participant reported acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Number of gout flares per participant was reported for this outcome measure. Flare days were counted up to Week 16, regardless of whether or not the flares occurred during the treatment period. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Baseline up to Week 20 | Safety analysis set that included all participants who received any study drug and safety analyses were based on the treatment received. | percentage of participants | NUMBER |
| SECONDARY | Number of Gout Flares Per Participant Assessed From Day 1 to Day 112 (Week 16) | Day 1 to Day 112 (Week 16) | Full analysis set (FAS) that included all randomized participants who received any study medication, and was based on the treatment allocated by the Interactive voice response system (IVRS) at randomization (as randomized). Here, number of participants analyzed=participants with available data for this endpoint. | Gout flares | MEAN |
| SECONDARY | Percentage of Participants With at Least One Flare From Day 1 to Day 112 (Week 16) | Day 1 to Day 112 (Week 16) | FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by the IVRS at randomization (as randomized). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With at Least Two Flares From Day 1 to Day 112 (Week 16) | Day 1 to Day 112 (Week 16) | FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by the IVRS at randomization (as randomized). | percentage of participants | NUMBER |
| SECONDARY | Number of Gout Flare Days Per Participant From Day 1 to Day 112 (Week 16) | Day 1 to Day 112 (Week 16) | FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by the IVRS at randomization (as randomized). Here, number of participants analyzed=participants with available data for this endpoint. | Gout flare Days | MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Placebo | With at least 1 TEAE | 59.1 | percentage of participants | |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Rilonacept 160 mg | With at least 1 TEAE | 66.6 | percentage of participants | |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Placebo | With TEAEs related to study drug | 13.0 | percentage of participants | |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Rilonacept 160 mg | With TEAEs related to study drug | 27.5 | percentage of participants | |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Placebo | With serious TEAEs | 3.9 | percentage of participants | |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Rilonacept 160 mg | With serious TEAEs | 3.1 | percentage of participants | |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Placebo | With TEAEs resulting in drug withdrawal | 3.3 | percentage of participants | |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Rilonacept 160 mg | With TEAEs resulting in drug withdrawal | 5.0 | percentage of participants | |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Placebo | With serious TEAEs resulting in drug withdrawal | 1.8 | percentage of participants | |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Rilonacept 160 mg | With serious TEAEs resulting in drug withdrawal | 1.1 | percentage of participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 330 | |
| Overall Study | STARTED | Rilonacept 160 mg | 985 | |
| Overall Study | COMPLETED | Placebo | 276 | |
| Overall Study | COMPLETED | Rilonacept 160 mg | 824 | |
| Overall Study | NOT COMPLETED | Placebo | 54 | |
| Overall Study | NOT COMPLETED | Rilonacept 160 mg | 161 |
Source ClinicalTrials.gov
Adverse events96
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection site erythema | General disorders | Placebo | 1 | 330 | 1 |
| other | Injection site erythema | General disorders | Rilonacept 160 mg | 61 | 985 | 195 |
| other | Accidental overdose | Injury, poisoning and procedural complications | Placebo | 20 | 330 | 21 |
| other | Accidental overdose | Injury, poisoning and procedural complications | Rilonacept 160 mg | 54 | 985 | 61 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo | 20 | 330 | 41 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Rilonacept 160 mg | 65 | 985 | 85 |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Placebo | 15 | 330 | 21 |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Rilonacept 160 mg | 52 | 985 | 74 |
| other | Headache | Nervous system disorders | Placebo | 26 | 330 | 45 |
| other | Headache | Nervous system disorders | Rilonacept 160 mg | 90 | 985 | 169 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Rilonacept 160 mg | ||
| Total, other adverse events | Placebo | 74 | 330 |
| Total, other adverse events | Rilonacept 160 mg | 266 | 985 |
| Total, serious adverse events | Placebo | 13 | 330 |
| Total, serious adverse events | Rilonacept 160 mg | 31 | 985 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25028379 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Rilonacept 160 mg vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00856206
GET https://conductscience.org/api/trials/v1/NCT00856206/results?page=2