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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT00856206 |
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Date of registration:
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21/02/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Review of Safety Using Rilonacept in Preventing Gout Exacerbations (RE-SURGE)
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Scientific title:
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A Multi-Center, Randomized, Double-Blind, Placebo Controlled Trial of the Safety of Rilonacept for the Prophylaxis of Gout Flares in Patients on Urate- Lowering Therapy |
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Date of first enrolment:
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March 2009 |
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Target sample size:
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1315 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00856206 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Germany
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India
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Indonesia
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South Africa
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Taiwan
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United States
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Contacts
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Name:
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Robert Evans, PharmD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Regeneron Pharmaceuticals |
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Key inclusion & exclusion criteria
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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;;;
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Gout
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Intervention(s)
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Biological: Rilonacept
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Other: Placebo
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Primary Outcome(s)
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Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
[Time Frame: Baseline up to Week 20]
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Secondary Outcome(s)
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Percentage of Participants With at Least Two Flares From Day 1 to Day 112 (Week 16)
[Time Frame: Day 1 to Day 112 (Week 16)]
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Number of Gout Flares Per Participant Assessed From Day 1 to Day 112 (Week 16)
[Time Frame: Day 1 to Day 112 (Week 16)]
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Percentage of Participants With at Least One Flare From Day 1 to Day 112 (Week 16)
[Time Frame: Day 1 to Day 112 (Week 16)]
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Number of Gout Flare Days Per Participant From Day 1 to Day 112 (Week 16)
[Time Frame: Day 1 to Day 112 (Week 16)]
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Secondary ID(s)
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IL1T-GA-0815
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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