Safety and Efficacy Study of PEG-uricase in the Treatment of Hyperuricemic Patients With Symptomatic Gout
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00325195 |
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Recruitment Status :
Completed
First Posted : May 12, 2006
Results First Posted : February 25, 2011
Last Update Posted : February 28, 2011
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Sponsor:
Savient Pharmaceuticals
Information provided by:
Savient Pharmaceuticals
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Gout |
| Interventions |
Other: placebo Biological: pegloticase |
| Enrollment | 225 |
Participant Flow
| Recruitment Details | Rheumatology practices across the US, Canada and Mexico |
| Pre-assignment Details | 13 subjects were randomized but withdrew before intervention. These subjects were not part of the modified Intent to Treat Population, which included only subjects who received at least one dose of study drug. |
| Arm/Group Title | q2 Wks | q4 Wks | Placebo |
|---|---|---|---|
 Arm/Group Description |
8 mg pegloticase every 2 weeks | 8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks) | placebo infusion every 2 weeks |
| Period Title: Randomized | |||
| Started | 90 | 89 | 46 |
| Completed | 85 | 84 | 43 |
| Not Completed | 5 | 5 | 3 |
| Reason Not Completed | |||
| Not dosed | 5 | 5 | 3 |
| Period Title: Received Intervention: ITT Population | |||
| Started | 85 | 84 | 43 |
| Completed | 59 | 59 | 39 |
| Not Completed | 26 | 25 | 4 |
| Reason Not Completed | |||
| Adverse Event | 15 | 17 | 1 |
| Death | 3 | 1 | 0 |
| Withdrawal by Subject | 7 | 6 | 1 |
| Lost to Follow-up | 0 | 0 | 2 |
| Protocol violation/non-compliance | 1 | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | q2 Wks | q4 Wks | Placebo | Total | |
|---|---|---|---|---|---|
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Arm/Group Description |
8 mg pegloticase every 2 weeks | 8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks) | placebo infusion every 2 weeks | Total of all reporting groups | |
| Overall Number of Baseline Participants | 85 | 84 | 43 | 212 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 85 participants | 84 participants | 43 participants | 212 participants | |
| <=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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| Between 18 and 65 years |
56 65.9%
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65 77.4%
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31 72.1%
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152 71.7%
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| >=65 years |
29 34.1%
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19 22.6%
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12 27.9%
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60 28.3%
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 85 participants | 84 participants | 43 participants | 212 participants | |
| 56.3 (15.53) | 54.5 (13.34) | 55.4 (12.21) | 55.4 (14.01) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 85 participants | 84 participants | 43 participants | 212 participants | |
| Female |
17 20.0%
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15 17.9%
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7 16.3%
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39 18.4%
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| Male |
68 80.0%
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69 82.1%
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36 83.7%
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173 81.6%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 85 participants | 84 participants | 43 participants | 212 participants |
| United States | 73 | 77 | 39 | 189 | |
| Canada | 1 | 1 | 1 | 3 | |
| Mexico | 11 | 6 | 3 | 20 | |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Multicenter publication is to be generated before any individual PI publishes on the results. If multicenter publication is not completed within 18 months from the date of completion, then PI can publish individual results from the Study. Sponsor can review results prior to public release and embargo for no more than 90 days. Sponsor can request removal of Confidential Information only.
Results Point of Contact
| Name/Title: | Medical Director |
| Organization: | Savient Pharmaceuticals, Inc. |
| Phone: | 732-418-9300 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Savient Pharmaceuticals, Inc |
| ClinicalTrials.gov Identifier: | NCT00325195 |
| Other Study ID Numbers: |
C0405 & C0406 |
| First Submitted: | May 10, 2006 |
| First Posted: | May 12, 2006 |
| Results First Submitted: | October 13, 2010 |
| Results First Posted: | February 25, 2011 |
| Last Update Posted: | February 28, 2011 |