Study Utilizing Rilonacept in Gout Exacerbations (SURGE)
This study has been completed.
Sponsor:
Regeneron Pharmaceuticals
Information provided by:
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00855920
First received: February 13, 2009
Last updated: June 23, 2011
Last verified: June 2011
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Purpose
This purpose of this clinical research is to determine the efficacy and safety of an experimental drug called rilonacept in subjects with an acute gout attack. Subjects will participate in in this study for 30 days. Rilonacept alone is being compared with indomethacin alone and the combination of rilonacept plus indomethacin in treating acute gout flares.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Gout Flare |
Drug: rilonacept Drug: indomethacin Other: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multi-Center, Randomized, Double-Blind, Active-Controlled Study of the Safety and Efficacy of Rilonacept Administered Subcutaneously for the Treatment of an Acute Gout Flare |
Resource links provided by NLM:
Further study details as provided by Regeneron Pharmaceuticals:
Primary Outcome Measures:
- The change in PAP (patient's assessment of pain) in the index joint from baseline measured over 72 hours [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- The change from baseline in PAP at Days 2, 3 and 4 [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]
| Enrollment: | 225 |
| Study Start Date: | March 2009 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Group 1
indomethacin and placebo
|
Drug: indomethacin
oral indomethacin for 12 days (50mg TID for 3 days, then 25mg TID x 9 days)
Other: placebo
placebo one time dose
|
|
Active Comparator: Group 2
rilonacept and indomethacin
|
Drug: rilonacept
rilonacept 320 mg SC injection at baseline
Drug: indomethacin
oral indomethacin for 12 days (50mg TID for 3 days, then 25mg TID x 9 days)
|
|
Active Comparator: Group 3
rilonacept and placebo
|
Drug: rilonacept
rilonacept 320 mg SC injection at baseline
Other: placebo
oral placebo TID x 12 days
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 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
- Subjects with history of chronic, gouty arthritis
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00855920
Show 44 Study Locations
Show 44 Study LocationsSponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
| Study Director: | Robert Evans, PharmD | Regeneron Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Robert Evans, PharmD / Director of Clinical Sciences, Regeneron Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00855920 History of Changes |
| Other Study ID Numbers: | IL1T-GA-0814 |
| Study First Received: | February 13, 2009 |
| Last Updated: | June 23, 2011 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Keywords provided by Regeneron Pharmaceuticals:
|
Metabolism, Inborn Errors Allopurinol Metabolic Diseases Genetic Diseases, Inborn Musculoskeletal Diseases Joint Diseases |
Arthritis Rheumatic Diseases Metabolic disorder Purine-Pyrimidine Metabolism, Inborn Errors Gout Flare |
Additional relevant MeSH terms:
|
Gout Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Metabolic Diseases Indomethacin Gout Suppressants Antirheumatic Agents Therapeutic Uses Pharmacologic Actions |
Tocolytic Agents Reproductive Control Agents Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Cardiovascular Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 21, 2013