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PREventative Study Against URate-lowering Drug-induced Gout Exacerbations 1 (PRE-SURGE1)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00829829
First Posted: January 27, 2009
Last Update Posted: April 28, 2017
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.
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
Results First Submitted: March 20, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Intercritical Gout
Interventions: Other: Placebo
Drug: Rilonacept 80 mg
Drug: Rilonacept 160 mg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 49 study sites in Unites States (US) and 15 study sites in Canada between 5 March 2009 and 18 May 2010. A total of 468 participants were screened in the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of 468 participants, 241 were randomized and 240 treated in the study. Participants were randomized in 1:1:1 ratio to receive either Placebo or Rilonacept 80 mg or Rilonacept 160 mg.

Reporting Groups
  Description
Placebo Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
Rilonacept 80 mg Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
Rilonacept 160 mg Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.

Participant Flow:   Overall Study
    Placebo   Rilonacept 80 mg   Rilonacept 160 mg
STARTED   80   80   81 
Treated [1]   79   80   81 
COMPLETED   58   64   70 
NOT COMPLETED   22   16   11 
Protocol Violation                0                3                0 
Adverse Event                4                4                3 
Withdrawal by Subject                8                4                2 
Decision by the Sponsor                1                0                2 
Lost to Follow-up                7                3                3 
Other than specified above                2                2                1 
[1] Participants treated were included in safety population.



  Baseline Characteristics
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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.
Baseline population included full analysis set (FAS) comprising of all randomized participants who received any study medication and was based on treatment allocated by Interactive voice response system (IVRS) at randomization (as randomized).

Reporting Groups
  Description
Placebo Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
Rilonacept 80 mg Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
Rilonacept 160 mg Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
Total Total of all reporting groups

Baseline Measures
   Placebo   Rilonacept 80 mg   Rilonacept 160 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 79   80   81   240 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.2  (13.6)   52.9  (12.5)   51.9  (11.6)   52.3  (12.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      3   3.8%      9  11.3%      5   6.2%      17   7.1% 
Male      76  96.2%      71  88.8%      76  93.8%      223  92.9% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      2   2.5%      2   2.5%      2   2.5%      6   2.5% 
Not Hispanic or Latino      77  97.5%      78  97.5%      79  97.5%      234  97.5% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      4   5.1%      5   6.3%      1   1.2%      10   4.2% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      1   1.2%      1   0.4% 
Black or African American      11  13.9%      15  18.8%      10  12.3%      36  15.0% 
White      64  81.0%      60  75.0%      69  85.2%      193  80.4% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Gout Flares Per Participant Assessed From Day 1 to Day 112 (Week 16)   [ Time Frame: Day 1 to Day 112 (Week 16) ]

2.  Secondary:   Number of Modified Gout Flares Per Participant From Day 1 to Day 112 (Week 16)   [ Time Frame: Day 1 to Day 112 (Week 16) ]

3.  Secondary:   Percentage of Participants With at Least One Gout Flare From Day 1 to Day 112 (Week 16)   [ Time Frame: Day 1 to Day 112 (Week 16) ]

4.  Secondary:   Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 112 (Week 16)   [ Time Frame: Day 1 to Day 112 (Week 16) ]

5.  Secondary:   Number of Gout Flare Days Per Participant From Day 1 to Day 112 (Week 16)   [ Time Frame: Day 1 to Day 112 (Week 16) ]

6.  Secondary:   Number of Gout Flare Days With Participant’s Pain Score of 5 or More (From Daily Diary) Per Participant From Day 1 to Day 112 (Week 16)   [ Time Frame: Day 1 to Day 112 (Week 16) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: Clinical Trial Management
Organization: Regeneron Pharmaceuticals, Inc. Phone:
e-mail: clinicaltrials@regeneron.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00829829     History of Changes
Other Study ID Numbers: IL1T-GA-0810
First Submitted: January 23, 2009
First Posted: January 27, 2009
Results First Submitted: March 20, 2017
Results First Posted: April 28, 2017
Last Update Posted: April 28, 2017