Study of the Safety and Effectiveness of Rilonacept for the Prevention of Gout Flares
This study has been completed.
Sponsor:
Regeneron Pharmaceuticals
Information provided by:
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00610363
First received: January 24, 2008
Last updated: June 1, 2011
Last verified: June 2011
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| Tracking Information | |||||
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| First Received Date ICMJE | January 24, 2008 | ||||
| Last Updated Date | June 1, 2011 | ||||
| Start Date ICMJE | November 2007 | ||||
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
number of flares during the treatment period [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00610363 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of the Safety and Effectiveness of Rilonacept for the Prevention of Gout Flares | ||||
| Official Title ICMJE | A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study, Tolerability, and Efficacy of Rilonacept for the Prevention of Gout Flares During Initiation of Allopurinol Therapy | ||||
| Brief Summary | This is a clinical research study to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are beginning another additional treatment. Subjects will participate in this study for approximately 24 weeks. Rilonacept is being studied for use in preventing gout attacks in patients who have gout. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Gout | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 83 | ||||
| Completion Date | October 2008 | ||||
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00610363 | ||||
| Other Study ID Numbers ICMJE | IL1T-GA-0619 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Robert Evans, PharmD/ Director of Clinical Sciences, Regeneron Pharmaceuticals, Inc | ||||
| Study Sponsor ICMJE | Regeneron Pharmaceuticals | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Regeneron Pharmaceuticals | ||||
| Verification Date | June 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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