A Phase 3 interventional study of Placebo and Rilonacept in Gout, sponsored by Regeneron Pharmaceuticals. Completed at 61 sites in 5 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-04-28.
Sponsored by Regeneron Pharmaceuticals · Phase 3, Interventional, and Treatment
The purpose of this clinical research study was to determine the safety and effectiveness of an experimental drug called rilonacept in participants with gout who are beginning allopurinol treatment for gout. Participants will participate in this study for approximately 22 weeks. Rilonacept was being studied for use in preventing allopurinol-induced gout flares.
232 studies on the registry are indexed under Gout; 45 are open to participants now.
This study's enrollment of 248 is above the median of 121 across 202 interventional studies indexed under Gout.
Browse Gout studies →Regeneron Pharmaceuticals is the lead sponsor of 400 studies on the registry; 91 are open to participants now.
Of its 120 completed or terminated interventional studies of FDA-regulated products, 77 (64%) have results posted.
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Exclusion Criteria:
Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
Drug: Placebo
Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
Drug: Rilonacept
Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
Drug: Rilonacept
Placebo loading dose followed by placebo subcutaneous (SC) injection (2 mL) once a week for 16 weeks.
Rilonacept 160 mg SC loading dose followed by Rilonacept 80 mg/2 mL SC injections once a week for 16 weeks.
Rilonacept 320 mg SC loading dose followed by Rilonacept 160 mg/2 mL SC injections once a week for 16 weeks.
Number of Gout Flares Per Participant Assessed From Day 1 to Day 113 (Week 16)
Gout flare was defined as 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.
Time frame: Day 1 to Day 113 (Week 16)
Number of Modified Gout Flares Per Participant From Day 1 to Day 113 (Week 16)
Modified gout flare was defined using modified definition of a gout flare as participant-reported articular pain typical of a gout attack that was deemed to require treatment with anti-inflammatory therapy. Number of modified gout flares per participant were reported for this outcome measure.
Time frame: Day 1 to Day 113 (Week 16)
Percentage of Participants With at Least One Flare From Day 1 to Day 113 (Week 16)
Gout flare was defined as 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.
Time frame: Day 1 to Day 113 (Week 16)
Percentage of Participants With at Least Two Flares From Day 1 to Day 113 (Week 16)
Gout flare was defined as 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 flares was reported for this outcome measure.
Time frame: Day 1 to Day 113 (Week 16)
Number of Gout Flare Days Per Participant From Day 1 to Day 113 (Week 16)
Gout flare was defined as 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 flare days per participant was reported for this outcome measure.
Time frame: Day 1 to Day 113 (Week 16)
Number of Gout Flare Days With Participant's Pain Score of 5 or More (From Daily Diary) Per Participant From Day 1 to Day 113 (Week 16)
Participants were asked to complete a telephone diary by calling the IVRS daily beginning at the baseline visit (Day 1) through the follow-up visit (Day 141) and reported their general well-being, gout symptoms, and weekly study drug administrations. At the onset of pain from a gout flare, participants were to answer additional diary questions regarding their gout flare and had to continue daily flare assessments until they reported the flare had ended. If a flare occurred just prior to the follow-up visit (Day 141), participants were to continue completing the daily diary until the flare resolved. Gout flare pain was assessed on a scale from 0 to 10 (with 0=no pain and 10=severe pain) within the past 24 hours.
Time frame: Day 1 to Day 113 (Week 16)
The study was conducted at 57 study sites in European Union (EU) and rest of world (ROW) between 7 March 2009 and 17 December 2010. A total of 471 participants were screened in the study.
| Milestone | Placebo | Rilonacept 80 mg | Rilonacept 160 mg |
|---|---|---|---|
| Started | 82 | 82 | 84 |
| Completed | 72 | 72 | 78 |
| Not completed | 10 | 10 | 6 |
| Withdrew: Protocol violation | 3 | 2 | 2 |
| Withdrew: Withdrawal by subject | 4 | 2 | 1 |
| Withdrew: Adverse event | 0 | 3 | 0 |
| Withdrew: Physician decision | 1 | 0 | 1 |
| Withdrew: Other than specified above | 2 | 3 | 2 |
Gout flare was defined as 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.
| Gout flares | Placebo | Rilonacept 80 mg | Rilonacept 160 mg |
|---|---|---|---|
| Number of Gout Flares Per Participant Assessed From Day 1 to Day 113 (Week 16) | 1.23 ± 1.57 | 0.35 ± 0.67 | 0.34 ± 0.86 |
Modified gout flare was defined using modified definition of a gout flare as participant-reported articular pain typical of a gout attack that was deemed to require treatment with anti-inflammatory therapy. Number of modified gout flares per participant were reported for this outcome measure.
| Gout flares | Placebo | Rilonacept 80 mg | Rilonacept 160 mg |
|---|---|---|---|
| Number of Modified Gout Flares Per Participant From Day 1 to Day 113 (Week 16) | 1.51 ± 1.87 | 0.62 ± 1.32 | 0.48 ± 0.99 |
Gout flare was defined as 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.
| percentage of participants | Placebo | Rilonacept 80 mg | Rilonacept 160 mg |
|---|---|---|---|
| Percentage of Participants With at Least One Flare From Day 1 to Day 113 (Week 16) | 56.1 | 25.6 | 20.5 |
Gout flare was defined as 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 flares was reported for this outcome measure.
| percentage of participants | Placebo | Rilonacept 80 mg | Rilonacept 160 mg |
|---|---|---|---|
| Percentage of Participants With at Least Two Flares From Day 1 to Day 113 (Week 16) | 32.9 | 8.5 | 6.0 |
Gout flare was defined as 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 flare days per participant was reported for this outcome measure.
| Gout flare days | Placebo | Rilonacept 80 mg | Rilonacept 160 mg |
|---|---|---|---|
| Number of Gout Flare Days Per Participant From Day 1 to Day 113 (Week 16) | 11.7 ± 21.0 | 4.30 ± 17.13 | 1.86 ± 5.80 |
Participants were asked to complete a telephone diary by calling the IVRS daily beginning at the baseline visit (Day 1) through the follow-up visit (Day 141) and reported their general well-being, gout symptoms, and weekly study drug administrations. At the onset of pain from a gout flare, participants were to answer additional diary questions regarding their gout flare and had to continue daily flare assessments until they reported the flare had ended. If a flare occurred just prior to the follow-up visit (Day 141), participants were to continue completing the daily diary until the flare resolved. Gout flare pain was assessed on a scale from 0 to 10 (with 0=no pain and 10=severe pain) within the past 24 hours.
| Gout flare days | Placebo | Rilonacept 80 mg | Rilonacept 160 mg |
|---|---|---|---|
| Number of Gout Flare Days With Participant's Pain Score of 5 or More (From Daily Diary) Per Participant From Day 1 to Day 113 (Week 16) | 4.28 ± 7.67 | 1.67 ± 8.43 | 0.88 ± 2.66 |
Collected over Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 4/82 (4.9%) | 12/82 (14.6%) |
| Rilonacept 80 mg | — | 5/82 (6.1%) | 20/82 (24.4%) |
| Rilonacept 160 mg | — | 3/84 (3.6%) | 20/84 (23.8%) |
| Event | Placebo | Rilonacept 80 mg | Rilonacept 160 mg |
|---|---|---|---|
| Umbilical hernia, obstructiveGastrointestinal disorders | 1/82 | 0/82 | 0/84 |
| AppendicitisInfections and infestations | 0/82 | 1/82 | 0/84 |
| PyelonephritisInfections and infestations | 0/82 | 1/82 | 0/84 |
| ContusionInjury, poisoning and procedural complications | 1/82 | 0/82 | 0/84 |
| FallInjury, poisoning and procedural complications | 1/82 | 0/82 | 0/84 |
| Post procedural complicationInjury, poisoning and procedural complications | 0/82 | 1/82 | 0/84 |
| Road traffic accidentInjury, poisoning and procedural complications | 1/82 | 0/82 | 0/84 |
| Tendon ruptureInjury, poisoning and procedural complications | 1/82 | 0/82 | 0/84 |
| Upper limb fractureInjury, poisoning and procedural complications | 1/82 | 0/82 | 0/84 |
| Gastric cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/82 | 1/82 | 0/84 |
| Event | Placebo | Rilonacept 80 mg | Rilonacept 160 mg |
|---|---|---|---|
| Injection site erythemaGeneral disorders | 0/82 | 6/82 | 7/84 |
| InfluenzaInfections and infestations | 6/82 | 5/82 | 5/84 |
| Accidental overdoseInjury, poisoning and procedural complications | 2/82 | 6/82 | 4/84 |
| NasopharyngitisInfections and infestations | 2/82 | 3/82 | 6/84 |
| HeadacheNervous system disorders | 2/82 | 5/82 | 1/84 |
Baseline population included all randomized participants.
| Age, Continuous(years) | Placebo | Rilonacept 80 mg | Rilonacept 160 mg | Total |
|---|---|---|---|---|
| Mean | 51.7 ± 12.87 | 52.6 ± 11.47 | 49 ± 11.77 | 51.1 ± 12.10 |
| Sex: Female, Male(Participants) | Placebo | Rilonacept 80 mg | Rilonacept 160 mg | Total |
|---|---|---|---|---|
| Female | 5 | 5 | 7 | 17 |
| Male | 77 | 77 | 77 | 231 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Rilonacept 80 mg | Rilonacept 160 mg | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 82 | 82 | 84 | 248 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo | Rilonacept 80 mg | Rilonacept 160 mg | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 29 | 23 | 30 | 82 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 10 | 14 | 10 | 34 |
| White | 43 | 45 | 44 | 132 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Regeneron Pharmaceuticals