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Study Utilizing Rilonacept in Gout Exacerbations (SURGE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00855920
First received: February 13, 2009
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: Acute Gout Flare
Interventions: Drug: Rilonacept
Drug: Indomethacin
Other: Placebo (for Indomethacin)
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 80 study sites in North America between 16 March 2009 and 26 February 2010. A total of 747 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 747 participants, 225 were randomized and treated in the study. Participants were randomized in 1:1:1 ratio to receive one of the three treatment groups (Placebo [for Rilonacept] + Indomethacin or Rilonacept 320 mg + Indomethacin or Rilonacept 320 mg + Placebo [for Indomethacin]) on Day 1 of the study.

Reporting Groups
  Description
Placebo (for Rilonacept) and Indomethacin Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally thrice a day (TID) for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
Rilonacept and Indomethacin Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
Rilonacept and Placebo (for Indomethacin) Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.

Participant Flow:   Overall Study
    Placebo (for Rilonacept) and Indomethacin   Rilonacept and Indomethacin   Rilonacept and Placebo (for Indomethacin)
STARTED   76   74   75 
Safety Population   77 [1]   73 [1]   75 
COMPLETED   68   65   64 
NOT COMPLETED   8   9   11 
Protocol Violation                0                0                2 
Adverse Event                2                1                1 
Lack of Efficacy                2                2                2 
Withdrawal by Subject                2                3                2 
Lost to Follow-up                1                0                2 
Death                0                1                0 
Decision by the sponsor                0                1                1 
Other than specified above                1                1                1 
[1] 1 participant from Rilonacept+Indomethacin arm received Placebo (for Rilonacept)+Indomethacin



  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 drug and had at least 1 post-baseline assessment.

Reporting Groups
  Description
Placebo (for Rilonacept) and Indomethacin Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
Rilonacept and Indomethacin Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
Rilonacept and Placebo (for Indomethacin) Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
Total Total of all reporting groups

Baseline Measures
   Placebo (for Rilonacept) and Indomethacin   Rilonacept and Indomethacin   Rilonacept and Placebo (for Indomethacin)   Total 
Overall Participants Analyzed 
[Units: Participants]
 75   74   73   222 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.3  (10.90)   48.6  (9.95)   51.0  (10.83)   50.3  (10.59) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      4   5.3%      3   4.1%      6   8.2%      13   5.9% 
Male      71  94.7%      71  95.9%      67  91.8%      209  94.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      3   4.0%      4   5.4%      5   6.8%      12   5.4% 
Not Hispanic or Latino      72  96.0%      70  94.6%      68  93.2%      210  94.6% 
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      1   1.3%      1   1.4%      0   0.0%      2   0.9% 
Asian      5   6.7%      2   2.7%      2   2.7%      9   4.1% 
Native Hawaiian or Other Pacific Islander      0   0.0%      2   2.7%      0   0.0%      2   0.9% 
Black or African American      15  20.0%      15  20.3%      11  15.1%      41  18.5% 
White      54  72.0%      54  73.0%      60  82.2%      168  75.7% 
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:   Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint to Averaged PAP-LS at 24, 48 and 72 Hours   [ Time Frame: Pre-dose on Day 1 (Baseline); post-dose at 4, 8, 12, 24, 48, 72 hours and then daily up to Day 13 or until gout flare ends ]

2.  Secondary:   Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 72 Hours   [ Time Frame: Baseline (Day 1) to 72 hours ]

3.  Secondary:   Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 48 Hours   [ Time Frame: Baseline (Day 1) to 48 hours ]

4.  Secondary:   Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 24 Hours   [ Time Frame: Baseline (Day 1) to 24 hours ]


  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.
e-mail: clinicaltrials@regeneron.com


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

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00855920     History of Changes
Other Study ID Numbers: IL1T-GA-0814
Study First Received: February 13, 2009
Results First Received: March 20, 2017
Last Updated: March 20, 2017