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Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares (UPSURGE)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01459796
First received: October 12, 2011
Last updated: June 19, 2017
Last verified: June 2017
Results First Received: April 23, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Gout
Interventions: Drug: Rilonacept
Drug: Placebo
Drug: Allopurinol

  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 60 study sites in the United States (US) from 12 November 2011 to 02 November 2012. A total of 485 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 485 participants, 220 were randomized and treated in the study. Participants were randomized in 4:3 ratio to receive either Rilonacept 80 mg or Placebo.

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 51.
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 51.

Participant Flow:   Overall Study
    Placebo   Rilonacept 80 mg
STARTED   94   126 
COMPLETED   0   0 
NOT COMPLETED   94   126 
Non compliance with protocol                2                4 
Adverse Event                5                5 
Withdrawal by Subject                6                3 
Lost to Follow-up                5                4 
Reason unspecified                1                2 
Decision by the sponsor                75                108 



  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 web response system (IWRS) 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 51.
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 51.
Total Total of all reporting groups

Baseline Measures
   Placebo   Rilonacept 80 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 94   126   220 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.5  (10.69)   52.1  (11.18)   51.9  (10.95) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      8   8.5%      15  11.9%      23  10.5% 
Male      86  91.5%      111  88.1%      197  89.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      7   7.4%      6   4.8%      13   5.9% 
Not Hispanic or Latino      87  92.6%      120  95.2%      207  94.1% 
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      1   1.1%      0   0.0%      1   0.5% 
Asian      2   2.1%      9   7.1%      11   5.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      3   2.4%      3   1.4% 
Black or African American      16  17.0%      27  21.4%      43  19.5% 
White      75  79.8%      87  69.0%      162  73.6% 
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:   Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)   [ Time Frame: Day 1 to Day 392 (Week 56) ]

2.  Secondary:   Percentage of Participants With at Least One Gout Flare From Day 1 to Day 168 (Week 24)   [ Time Frame: Day 1 to Day 168 (Week 24) ]

3.  Secondary:   Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 168 (Week 24)   [ Time Frame: Day 1 to Day 168 (Week 24) ]

4.  Secondary:   Percentage of Participants With at Least One Gout Flare From Day 1 to Day 364 (Week 52)   [ Time Frame: Day 1 to Day 364 (Week 52) ]

5.  Secondary:   Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 364 (Week 52)   [ Time Frame: Day 1 to Day 364 (Week 52) ]

6.  Secondary:   Percentage of Participants With Rescue Medication From Day 1 to Day 364 (Week 52)   [ Time Frame: Day 1 to Day 364 (Week 52) ]


  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



Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01459796     History of Changes
Other Study ID Numbers: IL1T-GA-1101
Study First Received: October 12, 2011
Results First Received: April 23, 2017
Last Updated: June 19, 2017