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Study of the Safety and Effectiveness of Rilonacept for the Prevention of Gout Flares

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00610363
First received: January 24, 2008
Last updated: March 20, 2017
Last verified: March 2017
Results First Received: March 20, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Condition: Gout
Interventions: Biological: Rilonacept
Other: Placebo (for Rilonacept)

  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 27 study sites in United States (US) between 19 November 2007 and 16 October 2008. A total of 154 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 154 participants, 83 were randomized and treated in the study. Participants were randomized in 1:1 ratio to receive either Placebo 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 16.
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 16.

Participant Flow:   Overall Study
    Placebo   Rilonacept 160 mg
STARTED   42   41 
COMPLETED   31   38 
NOT COMPLETED   11   3 
Non-compliance with protocol                0                1 
Adverse Event                3                1 
Lack of Efficacy                2                0 
Lost to Follow-up                4                0 
Withdrawal by Subject                1                0 
Other than specified above                1                1 



  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 16.
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 16.
Total Total of all reporting groups

Baseline Measures
   Placebo   Rilonacept 160 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 42   41   83 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.1  (11.59)   51.9  (10.61)   51.0  (11.09) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2   4.8%      1   2.4%      3   3.6% 
Male      40  95.2%      40  97.6%      80  96.4% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      1   2.4%      1   2.4%      2   2.4% 
Not Hispanic or Latino      41  97.6%      40  97.6%      81  97.6% 
Unknown or Not Reported      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% 
Asian      0   0.0%      2   4.9%      2   2.4% 
Native Hawaiian or Other Pacific Islander      1   2.4%      1   2.4%      2   2.4% 
Black or African American      3   7.1%      2   4.9%      5   6.0% 
White      38  90.5%      36  87.8%      74  89.2% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      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 84 (Week 12)   [ Time Frame: Day 1 (Baseline) to Day 84 (Week 12) ]

2.  Secondary:   Percentage of Participants With at Least One Gout Flare From Day 1 to Day 84 (Week 12)   [ Time Frame: Day 1 (Baseline) to Day 84 (Week 12) ]

3.  Secondary:   Mean Number of Gout Flares Per Month Per Participant From Day 1 to Day 84 (Week 12)   [ Time Frame: Day 1 (Baseline) to Day 84 (Week 12) ]

4.  Secondary:   Mean Number of Gout Flare Days Per Participant From Day 1 to Day 84 (Week 12)   [ Time Frame: Day 1 (Baseline) to Day 84 (Week 12) ]

5.  Secondary:   Mean Number of Gout Flare Days Per Month Per Participant From Day 1 to Day 84 (Week 12)   [ Time Frame: Day 1 (Baseline) to Day 84 (Week 12) ]

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 84 (Week 12)   [ Time Frame: Day 1 (Baseline) to Day 84 (Week 12) ]

7.  Secondary:   Number of Gout Flare Days With Participant’s Pain Score of 5 or More (From Daily Diary) Per Month Per Participant From Day 1 to Day 84 (Week 12)   [ Time Frame: Day 1 (Baseline) to Day 84 (Week 12) ]


  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
No text entered.


  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.
e-mail: clinicaltrials@regeneron.com


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

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00610363     History of Changes
Other Study ID Numbers: IL1T-GA-0619
Study First Received: January 24, 2008
Results First Received: March 20, 2017
Last Updated: March 20, 2017