We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Efficacy Study of PEG-uricase in the Treatment of Hyperuricemic Patients With Symptomatic Gout

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
Recruitment Status : Completed
First Posted : May 12, 2006
Results First Posted : February 25, 2011
Last Update Posted : February 28, 2011
Sponsor:
Information provided by:

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Rheumatology practices across the US, Canada and Mexico

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
q2 Wks 8 mg pegloticase every 2 weeks
q4 Wks 8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
Placebo placebo infusion every 2 weeks

Participant Flow for 2 periods

Period 1:   Randomized
    q2 Wks   q4 Wks   Placebo
STARTED   90   89   46 
COMPLETED   85   84   43 
NOT COMPLETED   5   5   3 
Not dosed                5                5                3 

Period 2:   Received Intervention: ITT Population
    q2 Wks   q4 Wks   Placebo
STARTED   85   84   43 
COMPLETED   59   59   39 
NOT COMPLETED   26   25   4 
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

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
q2 Wks 8 mg pegloticase every 2 weeks
q4 Wks 8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
Placebo placebo infusion every 2 weeks
Total Total of all reporting groups

Baseline Measures
   q2 Wks   q4 Wks   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 85   84   43   212 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   56   65   31   152 
>=65 years   29   19   12   60 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.3  (15.53)   54.5  (13.34)   55.4  (12.21)   55.4  (14.01) 
Gender 
[Units: Participants]
       
Female   17   15   7   39 
Male   68   69   36   173 
Region of Enrollment 
[Units: Participants]
       
United States   73   77   39   189 
Canada   1   1   1   3 
Mexico   11   6   3   20 


  Outcome Measures

1.  Primary:   Plasma Uric Acid (PUA) Responder   [ Time Frame: Months 3 and 6 ]

2.  Secondary:   Reduction in Tophus Burden   [ Time Frame: Baseline and Final Visit (6 months or LOCF) ]

3.  Secondary:   Percentage of Subjects With Gout Flare Per 3-month Period   [ Time Frame: Months 1-3 and Months 4-6 ]

4.  Secondary:   Change in Number of Swollen Joints   [ Time Frame: Baseline and Final Visit (Month 6 or LOCF) ]

5.  Secondary:   Change in Number of Tender Joints   [ Time Frame: Baseline and Final Visit (Month 6 or LOCF) ]

6.  Secondary:   Change in Patient Reported Outcomes of Pain, Physical Function and Quality of Life   [ Time Frame: Baseline to Final Visit (Month 6 or LOCF) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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     History of Changes
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